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Histone Deacetylase Inhibitor

Abexinostat + Pembrolizumab for Advanced Solid Tumor Malignancies

Phase 1
Waitlist Available
Led By Rahul Aggarwal, MD
Research Sponsored by Rahul Aggarwal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing abexinostat + pembrolizumab to treat participants with advanced MSI solid tumors. Abexinostat may stop tumor growth by blocking enzymes needed for cell growth. Pembrolizumab may stop tumor growth by interfering with the ability of tumor cells to grow and spread.

Eligible Conditions
  • Metastatic Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Ureter Cancer
  • Cutaneous Melanoma
  • Urothelial Carcinoma
  • Solid Tumors
  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximally Tolerated Dose (MTD)
Objective Response Rate (ORR)
Secondary outcome measures
Immune-modified Objective response rate (ORR)
Median DoR per iRECIST
Median Duration of Response (DoR)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose Escalation: (abexinostat, pembrolizumab)Experimental Treatment2 Interventions
Participants receive abexinostat PO BID on days -7 to -4 of the lead-in period, and days 1-4, 8-11 of each treatment cycle and pembrolizumab over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Cohort B: Dose Expansion (abexinostat, pembrolizumab)Experimental Treatment2 Interventions
Participants with acquired resistance, defined as treatment duration on prior CPI for greater than 6 months with evidence of clinical benefit (tumor regression or disease stabilization) with subsequent disease progression will receive abexinostat PO BID on days -7 to -4 of the lead-in period, and days 1-4, 8-11 of each treatment cycle and pembrolizumab over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group III: Cohort A: Dose Expansion (abexinostat, pembrolizumab)Experimental Treatment2 Interventions
Participants with primary resistance to prior anti-PD-1/PD-L1 will receive abexinostat PO BID on days -7 to -4 of the lead-in period, and days 1-4, 8-11 of each treatment cycle and pembrolizumab over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abexinostat
2018
Completed Phase 1
~40
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Rahul AggarwalLead Sponsor
11 Previous Clinical Trials
485 Total Patients Enrolled
Xynomic Pharmaceuticals, Inc.Industry Sponsor
10 Previous Clinical Trials
1,174 Total Patients Enrolled
Rahul Aggarwal, MDPrincipal Investigator - University of California, San Francisco
UCSF Medical Center at Parnassus
Northwestern University Medical Sch (Medical School)
22 Previous Clinical Trials
1,375 Total Patients Enrolled

Media Library

Abexinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03590054 — Phase 1
Cancer Research Study Groups: Dose Escalation: (abexinostat, pembrolizumab), Cohort A: Dose Expansion (abexinostat, pembrolizumab), Cohort B: Dose Expansion (abexinostat, pembrolizumab)
Cancer Clinical Trial 2023: Abexinostat Highlights & Side Effects. Trial Name: NCT03590054 — Phase 1
Abexinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03590054 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this research endeavor?

"The primary objective of this 2-year trial is to identify the Maximum Tolerated Dose. Additionally, we will collect data on Adverse Events reported by participants (as per NCI-CTCAE version 5), Median Duration of Response for complete and partial responses, as well as Immune-modified Objective Response Rate (iRECIST)."

Answered by AI

Are there any accessible opportunities for patients to join this experiment?

"Evidenced by the information on clinicaltrials.gov, this medical experiment is not presently enrolling patients; however, it was posted in August 2018 and last updated in May 2022. Though recruitment for this particular study has ended, there are 8,084 other trials currently admitting participants."

Answered by AI

Has Abexinostat received regulatory authorization from the FDA?

"Abexinostat's safety is rated as a 1 on our team at Power's scale, as this trial has yet to gather sufficient data to support its efficacy and the risk of adverse effects."

Answered by AI

How many participants are recruited for this research endeavor?

"Currently, this clinical trial is not accepting enrolments. Having been posted on August 20th 2018 and subsequently updated May 24th 2022, it no longer requires additional patients. For those seeking alternative studies, there are 7114 trials recruiting participants with melanoma and 970 for Abexinostat in operation."

Answered by AI

Has Abexinostat been evaluated for therapeutic efficacy before?

"Presently, there are 970 investigations being conducted for Abexinostat. 123 of these studies have reached the third phase of trials. While Houston, Texas is a major centre for this research, 35888 different medical sites around the world are running experiments with this drug."

Answered by AI

What medical condition is Abexinostat typically prescribed for?

"Abexinostat is regularly used to combat malignant neoplasms and, in some cases, can be given as a treatment for unresectable melanoma, microsatellite instability high states, and chemotherapy-induced progression of the disease."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies
Rahul Aggarwal 2018. "Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03590054.
~5 spots leftby Apr 2025
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