A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 138
- 试验地点
- 16
- 主要终点
- Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
研究概览
简要总结
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
- •Performance Status of 0, 1, or 2
- •Adequate bone marrow, kidney, and liver function
排除标准
- •OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction
- •Brain metastases requiring steroids
- •Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
- •Active and clinically significant bacterial, fungal, or viral infection
- •Q3W Inclusion Criteria:
- •Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
- •Performance Status of 0 or 1
- •Adequate bone marrow, kidney, and liver function
- •Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients
- •Q3W Exclusion Criteria:
- •OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction
- •Brain metastases requiring steroids
- •Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
- •Active and clinically significant bacterial, fungal, or viral infection
研究组 & 干预措施
PF-06647020 Q3W
Investigational drug infused over 60 minutes once every 21 days.
干预措施: PF-06647020 Q3W (Drug)
Drug-drug interaction (DDI)
PF-06647020 combined with fluconazole
干预措施: fluconazole (Drug)
PF-06647020 Q2W
Investigational drug infused over 60 minutes once every 14 days (28 day cycle)
干预措施: PF-06647020 Q2W (Drug)
PF-06647020 combined with Avelumab
PF-06647020 combined with Avelumab administered by infusion
干预措施: PF-06647020 combined with Avelumab (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
时间窗: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen
时间窗: Baseline and Day 1 of Cycle 1
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
时间窗: From baseline to end of treatment (approximately 19 months).
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.
Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)
时间窗: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
时间窗: From baseline to end of treatment (approximately 32 months).
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets.
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
时间窗: From baseline to end of treatment (approximately 32 months).
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia.
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen
时间窗: From baseline to end of treatment (approximately 19 months).
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia.
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen
时间窗: From baseline to end of treatment (approximately 19 months).
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio.
Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen
时间窗: First Cycle, Day 1 up to Day 21
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 anemia; Grade \>=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade \>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin \>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.
Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)
时间窗: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
时间窗: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Number of Participants With DLTs - Q2W Regimen
时间窗: First cycle, Day 1 up to Day 28
A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay \>14 days because of hematologic AE; (2) Hepatic: including Grade\>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST\>=3.0 x ULN concurrent with elevation in bilirubin\>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade \>=3 headache lasting \>48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days.
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)
时间窗: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)
时间窗: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen
时间窗: From baseline to end of treatment (approximately 32 months).
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen
时间窗: From baseline to end of treatment (approximately 32 months).
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time.
次要结局
- t1/2 for PF-06380101 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Rac for PF-06380101 - Q3W Regimen(pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).)
- Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen(pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).)
- AUCtau for PF-06380101 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Cmax for hu6M024 mAb - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- t1/2 for hu6M024 mAb - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- AUClast for hu6M024 mAb - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen(Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months).)
- Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Clearance (CL) for PF-06647020 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- AUClast for PF-06380101 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Rac for hu6M024 mAb - Q3W Regimen(pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).)
- Disease Control Rate - Q3W Regimen(Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).)
- Cmax(dn) for PF-06380101 [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Tmax for PF-06380101 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- AUCinf for PF-06380101 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- AUCtau for hu6M024 mAb - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Percentage of Participants With Objective Response - Q3W Regimen(Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).)
- Duration of Response - Q3W Regimen(Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).)
- Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Cmax for PF-06380101 - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Time to Progression - Q3W Regimen(Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).)
- Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- AUCinf(dn) for PF-06380101 [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- Cmax for PF-06380101 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- AUClast for PF-06380101- Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Tmax for hu6M024 mAb - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- AUCtau(dn) for hu6M024 mAb [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- CL for PF-06647020 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- t1/2 for PF-06647020 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- AUCinf for PF-06647020 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- AUClast(dn) for PF-06380101 [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- AUCinf for hu6M024 mAb - Q3W Regimen(pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).)
- Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- Rac for PF-06647020 - Q2W Regimen(pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).)
- Tmax for PF-06380101 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Progression Free Survival - Q3W Regimen(Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).)
- Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- AUCtau(dn) for PF-06380101 [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- AUCinf(dn) for hu6M024 mAb [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- AUClast(dn) for hu6M024 mAb [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- AUCtau for PF-06647020 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Tmax for PF-06647020 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- t1/2 for PF-06380101 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Cmax for hu6M024 mAb -Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Rac for hu6M024 mAb - Q2W Regimen(pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).)
- Cmax(dn) for hu6M024 mAb [DDI Sub-Study](pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).)
- Cmax for PF-06647020 -Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Vss for PF-06647020 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- AUClast for PF-06647020 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Tmax for hu6M024 mAb - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- AUCtau for PF-06380101 - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Rac for PF-06380101 - Q2W Regimen(pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).)
- AUCinf for PF-06380101- Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Progression Free Survival - Q2W Regimen(Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).)
- Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen(2 hours before the first dose up to 30 days after the last dose (approximately 18 months).)
- AUCtau for hu6M024 mAb- Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Disease Control Rate - Q2W Regimen(Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).)
- Time to Progression - Q2W Regimen(Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).)
- t1/2 for hu6M024 mAb - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- AUClast for hu6M024 mAb - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- AUCinf for hu6M024 mAb - Q2W Regimen(pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).)
- Percentage of Participants With Objective Response - Q2W Regimen(Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).)
- Duration of Response - Q2W Regimen(Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).)