A Phase 1b Dose Escalation/Expansion Study of Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Urothelial Carcinoma
- Locally Advanced Melanoma
- Locally Advanced Solid Neoplasm
- Stage IVA Lung Cancer AJCC v8
- Metastatic Head and Neck Squamous Cell Carcinoma
- Metastatic Malignant Solid Neoplasm
- Metastatic Melanoma
- Stage III Ureter Cancer AJCC v8
- Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Non Small Cell Lung Carcinoma
- Stage IV Cutaneous Melanoma
- Stage IV Lung Cancer AJCC v8
- Stage IB Lung Cancer AJCC v7
- Stage IIIB Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Stage III Cutaneous Melanoma
- Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- Stage IV Ureter Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the maximally tolerated and recommended phase 2 dose of abexinostat in combination with anti-PD-1/PD-L1 checkpoint inhibitor (CPI). (Dose escalation) II. To determine the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 cr...
PRIMARY OBJECTIVES: I. To determine the maximally tolerated and recommended phase 2 dose of abexinostat in combination with anti-PD-1/PD-L1 checkpoint inhibitor (CPI). (Dose escalation) II. To determine the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients treated with abexinostat in combination with CPI in patients with prior primary (cohort A) or acquired (cohort B) resistance to prior CPI treatment. (Dose expansion) SECONDARY OBJECTIVES: I. To determine the objective response rate and median duration of response (DoR) by immune modified (i)RECIST criteria. II. To determine the median progression-free survival (PFS). III. To further characterize the safety profile of the treatment combination. OUTLINE: This is a dose-escalation study of abexinostat. Participants receive abexinostat orally (PO) twice daily (BID) on days 1-21 and pembrolizumab intravenously (IV) on over 30 minutes day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up for 90 days.
Tracking Information
- NCT #
- NCT03590054
- Collaborators
- Xynomic Pharmaceuticals, Inc.
- Investigators
- Principal Investigator: Rahul Aggarwal, MD University of California, San Francisco
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