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Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies

NCT03590054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-03-22

No results posted yet for this study

Summary

This phase I trial studies the best dose and side effects of abexinostat and how well it works with given together with pembrolizumab in treating participants with microsatellite instability (MSI) solid tumors that have spread to other places in the body. Abexinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving abexinostat and pembrolizumab may work better in treating participants with solid tumors.

Conditions

  • Stage III Cutaneous Melanoma
  • Stage IV Cutaneous Melanoma
  • Locally Advanced Melanoma
  • Locally Advanced Solid Neoplasm
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Metastatic Urothelial Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Stage IB Lung Cancer AJCC v7
  • Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage III Ureter Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Ureter Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Interventions

DRUG

Abexinostat

Given orally (PO) twice a day (BID) days 1-4, 8-11 of every 21 day cycle

BIOLOGICAL

Pembrolizumab

Given IV on day 1 of every 21 day cycle

Sponsors & Collaborators

  • Xynomic Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Rahul Aggarwal

    lead OTHER

Principal Investigators

  • Rahul Aggarwal, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03590054 on ClinicalTrials.gov