A Phase I/II Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in Patients With Relapsed/Refractory Small Cell Lung, Bladder and Prostate Cancers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of EP0057 (CLRX101) in Participants With Refractory Cancers.
研究概览
简要总结
Background: EP0057 (formerly CRLX101) consists of a sugar molecule cyclodextrin linked to a chemotherapy drug called camptothecin. The combined molecule or "nanoparticle drug conjugate" travels through the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule. Olaparib is a drug that may stop cancer cells from repairing the deoxyribonucleic acid (DNA) damage caused by chemotherapy. Researchers want to see how safe it is to give EP0057 and olaparib together and to see how well the combination treats a specific type of lung cancer called small cell lung cancer (SCLC).
Objectives:
To test the safety and maximum dose of EP0057 and olaparib together. To test how well they treat small cell lung cancer.
Eligibility:
Adults 18 and older with small cell lung cancer.
Design:
Participants will be screened with standard cancer care tests.
Participants will get the 2 study drugs in 28-day cycles. EP0057 will be given every 2 weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a day most days. Participants will keep a pill diary.
For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits.
At study visits, participants may have:
- Blood and hair samples taken
- History and Physical exam
- Questions about health and side effects
- Pregnancy test
- Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin.
- Computed tomography (CT) scan
- Injection of EP0057 (twice per cycle)
- Olaparib prescription
Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will have a physical exam and blood tests. They may have a tumor biopsy. The study team will call the patient every 3 months for follow up after completing the study treatment.
详细描述
Background:
- Small cell lung cancer (SCLC) is an aggressive cancer with a poor prognosis.
- Although highly responsive to chemotherapy initially, SCLC relapses quickly and becomes refractory to treatment within a few months.
- Urothelial Carcinoma (UC) of the Bladder is the fourth most common malignancy in men and the ninth most common in women.
- Prostate cancer is the most common cancer among men in the United States. While prostate cancer is initially responsive to androgen deprivation therapy (ADT), the median duration of sensitivity is 24-36 months. Moreover, patients develop resistance to current treatment options.
- The use of poly adenosine diphosphate ribose polymerase (PARP) inhibitors in combination with chemotherapy builds upon pre-clinical data in lung cancer and other cancers supporting the notion that PARP inhibitors potentiate the effect of deoxyribonucleic acid (DNA) damaging therapies.
- Despite their highly synergistic activity in preclinical models, human studies combining PARP inhibitors and camptothecins have not translated into clinical benefit due to enhanced toxicity with the combination.
- One approach to improve ability to combine camptothecins with agents that sensitize their activity like PARP inhibitors is to use alternative formulations that minimize toxicity to the normal tissues.
- EP0057 (formerly CRLX101) is a nanoparticle drug conjugate composed of 20 (S)-camptothecin (a potent and highly selective topoisomerase I inhibitor) conjugated to a linear, cyclodextrin polyethylene glycol-based polymer.
- Olaparib is a PARP inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline breast cancer gene (BRCA) mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Olaparib has an established safety profile, and it is under investigation in a number of different cancers.
Objectives:
- Phase I: To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of EP0057 in combination with olaparib in patients with refractory cancers.
- Phase II: To determine the antitumor activity of olaparib plus EP0057 with respect to progression free survival at 16 weeks in SCLC patients with resistant or sensitive relapse.
- Expansion Cohorts: To determine overall response rate of EP0057 plus olaparib in patients with mCRPC and urothelial carcinoma.
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •* INCLUSION CRITERIA: - Phase I
- •* Patients must have histologically or cytologically confirmed advanced solid tumor that is resistant or refractory to standard therapy.
- •* A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade \<= 1 from all reversible toxicities related to prior therapy is required at study entry.
- •* Patients do not need to have measurable disease to enroll on phase I.
- •* Age 18 years.
- •* Eastern cooperative Oncology Group (ECOG) performance status \<=2
- •* Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed.
- •* Patients must have normal organ and marrow function as defined below:
- •* leukocytes \>=3,000/mcL
- •* absolute neutrophil count \>=1,500/mcL without growth factor support
- •* platelets \>=100,000/mcL without growth factor support
- •* hemoglobin \>=9 g/dL, and no blood transfusion within 4 weeks.
- •* Hemoglobin \>10 g/dL, and no blood transfusion within 2 weeks.
- •* total bilirubin \<=1.5 x upper limit of normal (ULN) (unless Gilbert's Disease)
- •* Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT)\<=2.5 X institutional upper limit of normal (\<= 5X ULN if liver mets)
- •* creatinine \<= ULN
- •* creatinine clearance \>= 51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.
- •-The effects of EP0057 (formerly CRLX101) and olaparib on the developing human fetus are unknown. For this reason and because these agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as:
- •* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
- •* Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for women under 50,
- •* radiation-induced oophorectomy with last menses \>1 year ago,
- •* chemotherapy-induced menopause with \>1 year interval since last menses,
- •* or surgical sterilization (bilateral oophorectomy or hysterectomy).
- •* Negative urine pregnancy test \< =3 days prior to cycle 1 day 1 (C1D1) (women of childbearing potential only)
- •* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •INCLUSION CRITERIA: - Phase II Small Cell Lung Cancer (SCLC)
- •* Age \>=18 years.
- •* Patients must have histologically or cytologically confirmed diagnosis of SCLC from a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
- •* Have received and progressed during or after a platinum-based standard chemotherapy regimen and/or an immune-checkpoint inhibitor
- •* Patients could have received any number of therapies for relapsed or progressive disease, including re-treatment with original frontline regimen. A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade \<= 1 from all reversible toxicities related to prior therapy is required at study entry. No previous irradiation to the site of measurable or evaluable disease, unless that site had subsequent evidence of progression.
- •* Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors, version (RECIST 1.1).
- •* Radiographic evidence of disease progression after initial therapy should have been documented.
- •* Eastern Cooperative Oncology Group (ECOG) performance status \<=2.
- •* Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed.
- •* Patients must have normal organ and marrow function as defined below:
- •* Leukocytes \>=3,000/mcL
- •* absolute neutrophil count \>=1,500/mcL without growth factor support
- •* platelets \>=100,000/mcL without growth factor support
- •* hemoglobin \>=9 g/dL, and no blood transfusion within 4 weeks.
- •* hemoglobin \>10 g/dL, and no blood transfusion within 2 weeks.
- •* total bilirubin \<=1.5 x upper limit of normal (ULN) (unless Gilbert's Disease)
- •* AST(SGOT)/ALT(SGPT) \<=2.5 X institutional upper limit of normal (\<= 5X ULN if liver mets)
- •* creatinine \<= ULN
- •* creatinine clearance \>=51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.
- •* The effects of EP0057 and olaparib on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of child-bearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as:
- •* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
- •* LH and FSH levels in the post-menopausal range for women under 50,
- •* radiation-induced oophorectomy with last menses \>1 year ago,
- •* chemotherapy-induced menopause with \>1 year interval since last menses,
- •* or surgical sterilization (bilateral oophorectomy or hysterectomy).
- 另有 48 项未显示
排除标准
- •Phase I and II SCLC and UC Expansion Cohort (note: accrual to the UC cohort ended with amendment version 08/17/2022)
- •Patients who are receiving any other investigational agents.
- •Persistent toxicities (>= Common Terminology Criteria for Adverse Events (CTCAE) grade 2) with the exception of alopecia and neuropathy, caused by previous cancer therapy
- •Patients who have had prior treatment with olaparib or other camptothecin inhibitors (Ulcerative Colitis (UC) expansion Cohort Only).
- •Patients with myelodysplastic syndrome/acute myeloid leukemia or active pneumonitis; or baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated.
- •Hypersensitivity to study therapies ...
研究组 & 干预措施
1/Phase I - EP0057 (formerly CRLX101) + Olaparib
EP0057 + olaparib
干预措施: ECG (Diagnostic Test)
1/Phase I - EP0057 (formerly CRLX101) + Olaparib
EP0057 + olaparib
干预措施: Biopsy (Procedure)
2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
干预措施: CT scan (Diagnostic Test)
2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
干预措施: CT chest, abdomen, and pelvis (Diagnostic Test)
2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
干预措施: Bone scan (Diagnostic Test)
2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
干预措施: ECG (Diagnostic Test)
1/Phase I - EP0057 (formerly CRLX101) + Olaparib
EP0057 + olaparib
干预措施: CT scan (Diagnostic Test)
1/Phase I - EP0057 (formerly CRLX101) + Olaparib
EP0057 + olaparib
干预措施: CT chest, abdomen, and pelvis (Diagnostic Test)
1/Phase I - EP0057 (formerly CRLX101) + Olaparib
EP0057 + olaparib
干预措施: EP0057 (Drug)
1/Phase I - EP0057 (formerly CRLX101) + Olaparib
EP0057 + olaparib
干预措施: olaparib (Drug)
2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
干预措施: olaparib (Drug)
2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
干预措施: EP0057 (Drug)
1/Phase I - EP0057 (formerly CRLX101) + Olaparib
EP0057 + olaparib
干预措施: Echocardiogram (Diagnostic Test)
1/Phase I - EP0057 (formerly CRLX101) + Olaparib
EP0057 + olaparib
干预措施: Bone scan (Diagnostic Test)
2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
干预措施: Echocardiogram (Diagnostic Test)
2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
干预措施: Biopsy (Procedure)
结局指标
主要结局
Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of EP0057 (CLRX101) in Participants With Refractory Cancers.
时间窗: First 28 days
MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity.
Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Olaparib in Participants With Refractory Cancers.
时间窗: First 28 days
MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity.
Number of Dose Limiting Toxicities (DLTs) During the First Cycle
时间窗: First 28 days
DLTs will be defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4). The following toxicities, occurring during cycle 1 of the study combination, will be considered DLTs if deemed drug-related: Grade 4 neutropenia complicated by fever ≥38.5C and/or documented infection; Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia that does not resolve within 7 days or grade 3-4 thrombocytopenia complicated with hemorrhage. Grade 4 anemia that does not resolve within 7 days despite optimal therapy; and inability to begin subsequent treatment course within 28 days of the scheduled date, due to study drug toxicity, and any Grade 3-4 non-hematologic toxicity except fatigue/asthenia \<2 weeks in duration).
Expansion: Progression Free Survival (PFS) Rate in the Combination of Olaparib Plus EP0057 (CLRX101) at 16 Weeks in Small Cell Lung Cancer (SCLC) Participants
时间窗: 16 weeks
Determine if slightly more than 50% of participants may be identified as being without progression by 16 weeks. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Urothelial Carcinoma
时间窗: 8 weeks
Overall response rate is the best response recorded from the start of the treatment until disease progression/recurrence. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
时间窗: 12 weeks
Determine if slightly more than 50% of participants may be identified as being without progression by 12 weeks. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
次要结局
- Duration of Response (DOR) of the Combination(At baseline and after every 2 cycles up until the date of first documented progression or an average of average 11.09 months.)
- Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts(Start of treatment through 30 days post last dose, an average of 8.26 months.)
- Progression-free Survival (PFS) on Expansion Cohorts(Every 3 months post-treatment, up until date of death from any cause or an average of 9.57 months.)
- Progression-free Survival (PFS) of the Combination(Duration of time from start of treatment to time of progression or death, whichever occurs first, up to 2.5 years)
- Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) With an 80% Confidence Interval(40.71 weeks from start of treatment to best response date)
- Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) an 95% Confidence Interval(40.71 weeks from start of treatment to best response date.)
- Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts(Start of treatment through 30 days post last dose, up to 3.99 months)
- Maximum Observed Plasma Concentration of EP0057 (Both the Total Drug and Released Camptothecin) and Olaparib(Cycle 1 (pre-dose, mid-infusion (30 minutes), end of infusion (EOI), and 1, 2, 12, 24, and 48 hours (hr) post-EOI); and Cycle 6 Day 1.)
- Mean Change From Baseline γ- H2A Histone Family Member X (H2AX) Intensity in Plucked Hair Follicles(4 days)
- Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, and 3) With Probable Association to Study Regimen in Participants on Expansion Cohorts(Start of treatment through 30 days post last dose, an average of 8.26 months.)
- Progression-free Survival (PFS) on Expansion Cohorts(Every 3 months post-treatment, up until date of death from any cause or an average of 9.57 months.)
- Progression-free Survival (PFS) of the Combination(Duration of time from start of treatment to time of progression or death, whichever occurs first, up to 2.5 years)
- Overall Survival (OS) of the Combination(Date of on-study to the date of death from any cause or last follow up, up to 2.5 years)
- Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) With an 80% Confidence Interval(40.71 weeks from start of treatment to best response date)
- Prostate-specific Antigen (PSA) on Metastatic Castration-Resistant Prostate Cancer (mCRPC) Expansion Cohort Reported at Time of Documented Partial Response (PR) an 95% Confidence Interval(40.71 weeks from start of treatment to best response date.)
- Duration of Response (DOR) of the Combination(At baseline and after every 2 cycles up until the date of first documented progression or an average of average 11.09 months.)
- Occurrences of Toxicities Including Toxicity Type and Severity (Grades 1, 2, 3, 4 and/or 5) With Probable Association to Study Regimen in Participants on Solid Tumor Cohorts(Start of treatment through 30 days post last dose, up to 3.99 months)
- Maximum Observed Plasma Concentration of EP0057 (Both the Total Drug and Released Camptothecin) and Olaparib(Cycle 1 (pre-dose, mid-infusion (30 minutes), end of infusion (EOI), and 1, 2, 12, 24, and 48 hours (hr) post-EOI); and Cycle 6 Day 1.)
- Pharmacodynamic (PD) Activity of EP0057 in Surrogate Tissue Specimens(Baseline, Cycle 1, then every 2 cycles, and at progression)
- Pharmacodynamic (PD) Activity of EP0057 in Tumor Biopsy Specimens(Baseline, Cycle 1, then every 2 cycles, and at progression)
研究者
Anish Thomas
Principal Investigator
National Cancer Institute (NCI)