An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 80
- 主要终点
- MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab
研究概览
简要总结
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Part 4 NSCLC Cohort F3 was randomized 1;1:1, open-label
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
- •Select Inclusion Criteria:
- •Males or females aged ≥18 years.
- •Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.
- •Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G/GEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.
- •Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G/GEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.
- •For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1/L1 regimen.
- •For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1/L1 in curative (neo-adjuvant/adjuvant) setting is allowed only if completed >/= 6 months prior to progression to local recurrence or metastatic disease.
- •For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery.
- •All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.
- •PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable.
- •Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.
排除标准
- •Prior exposure to OX40 agonists. Exposure to anti-PD-1 and/or anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways.
- •Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.
- •Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)
- •Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-
- •Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
- •Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.
- •Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
- •History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.
- •Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
- •Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation <92% on room air.
- •Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial.
- •Major surgery within 4 weeks prior to enrollment on this trial.
- •Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.
- •Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.
- •Additional in- and exclusion criteria per protocol.
研究组 & 干预措施
Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting)
INBRX-106 will be escalated, in combination with pembrolizumab, in subjects with locally advanced or metastatic solid tumors.
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting)
Subjects with melanoma (any type), head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma or MSI/TMB-high tumors that are relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)
Subjects with non-small cell lung cancer will be treated with alternating dosing of INBRX-106 0.3 mg/kg Q6W and 400 mg pembrolizumab IV Q6W. This is one of the randomized cohorts.
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)
Subjects with non-small cell lung cancer will be given a 0.3 mg/kg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg/kg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts.
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting)
Subjects with non-small cell lung cancer will be treated with 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts.
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting
Subjects with solid tumors that have confirmed MSI-high, TMB-high or MMR-deficient states who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting)
Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks
干预措施: Nab paclitaxel 100mg/m2 (Drug)
Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 200mg/m2 paclitaxel and carboplatin AUC-6 IV every 3 weeks OR INBRX-106, 200mg pembrolizumab, 100mg/m2 nab-paclitaxel (dosed Days 1,8 and 15 every cycle) and carboplatin AUC-6 IV every 3 weeks. Treating physician to determine if paclitaxel or nab-paclitaxel will be given
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks
干预措施: pembrolizumab 200 mg (Drug)
Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting)
Subjects with melanoma (any type), head and neck squamous cell carcinoma (non-nasopharyngeal) OR nasopharyngeal carcinoma, MSI-high, TMB-high or MMR-deficient tumors, will be treated with INBRX-106 in combination with 200mg pembrolizumab IV every 3 weeks.
干预措施: pembrolizumab 200 mg (Drug)
Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC
Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 (dosed Day 1 only) with gemcitabine 1000 mg/m2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 with pemetrexed 500 mg/m2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin following Cycle 1 at the Investigator's discretion and per protocol and due to cisplatin-related toxicity. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg/kg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles.
干预措施: Cisplatin 75mg/m2 (Drug)
Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting)
Subjects with non-small cell carcinoma relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106
干预措施: pembrolizumab 200 mg (Drug)
Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting)
Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks
干预措施: Carboplatin AUC-5 (Drug)
Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)
Subjects with non-small cell lung cancer will be treated with alternating dosing of INBRX-106 0.3 mg/kg Q6W and 400 mg pembrolizumab IV Q6W. This is one of the randomized cohorts.
干预措施: pembrolizumab 400 mg (Drug)
Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC
Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 (dosed Day 1 only) with gemcitabine 1000 mg/m2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 with pemetrexed 500 mg/m2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin following Cycle 1 at the Investigator's discretion and per protocol and due to cisplatin-related toxicity. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg/kg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles.
干预措施: pembrolizumab 200 mg (Drug)
Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)
Subjects with non-small cell lung cancer will be given a 0.3 mg/kg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg/kg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts.
干预措施: pembrolizumab 200 mg (Drug)
Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)
Subjects with non-small cell lung cancer will be given a 0.3 mg/kg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg/kg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts.
干预措施: pembrolizumab 400 mg (Drug)
Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting
Subjects with solid tumors that have confirmed MSI-high, TMB-high or MMR-deficient states who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks
干预措施: pembrolizumab 200 mg (Drug)
Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting)
Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks
干预措施: pembrolizumab 200 mg (Drug)
Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC
Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 (dosed Day 1 only) with gemcitabine 1000 mg/m2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 with pemetrexed 500 mg/m2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin following Cycle 1 at the Investigator's discretion and per protocol and due to cisplatin-related toxicity. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg/kg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles.
干预措施: Carboplatin AUC-5 (Drug)
Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting)
Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks
干预措施: Pemetrexed 500 mg/m2 (Drug)
Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks
干预措施: Pemetrexed 500 mg/m2 (Drug)
Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks
干预措施: pembrolizumab 200 mg (Drug)
Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks
干预措施: Carboplatin AUC-6 (Drug)
Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks
干预措施: Paclitaxel 200mg/m2 (Drug)
Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 200mg/m2 paclitaxel and carboplatin AUC-6 IV every 3 weeks OR INBRX-106, 200mg pembrolizumab, 100mg/m2 nab-paclitaxel (dosed Days 1,8 and 15 every cycle) and carboplatin AUC-6 IV every 3 weeks. Treating physician to determine if paclitaxel or nab-paclitaxel will be given
干预措施: pembrolizumab 200 mg (Drug)
Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC
Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 (dosed Day 1 only) with gemcitabine 1000 mg/m2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 with pemetrexed 500 mg/m2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin following Cycle 1 at the Investigator's discretion and per protocol and due to cisplatin-related toxicity. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg/kg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles.
干预措施: Pemetrexed 500 mg/m2 (Drug)
Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC
This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks
干预措施: Cisplatin 75mg/m2 (Drug)
Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting)
Subjects with melanoma (any type), head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma or MSI/TMB-high tumors that are relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106
干预措施: pembrolizumab 200 mg (Drug)
Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting)
INBRX-106 will be escalated, in combination with pembrolizumab, in subjects with locally advanced or metastatic solid tumors.
干预措施: pembrolizumab 200 mg (Drug)
Part 1 INBRX-106 Escalation (Not Recruiting)
INBRX-106 will be escalated in subjects with locally advanced or metastatic solid tumors.
干预措施: INBRX-106 - Hexavalent OX40 agonist antibody (Drug)
结局指标
主要结局
MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab
时间窗: ~2 years
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-106 and INBRX-106 in combination with pembrolizumab
Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC
时间窗: ~2 years
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
时间窗: ~2 years
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
时间窗: ~2 years
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts
时间窗: ~2 years
The evaluation of efficacy will be based on the subject's measurable disease using RECIST v1.1
Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC
时间窗: ~2 years
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant/adjuvant therapy in adult subjects with NSCLC. (Cohort F8)
时间窗: ~2 years
Major pathological response (mPR) and pathological complete response (cPR) criteria.
次要结局
- Maximum observed serum concentration (Cmax) of INBRX-106(~2 years)
- Immunogenicity of INBRX-106(~2 years)
- Time to Cmax (Tmax) of INBRX-106(~2 years)
- Area under the serum concentration time curve (AUC) of INBRX-106(~2 years)
- Trough observed serum concentration (Ctrough) of INBRX-106(~2 years)