ACR-368 for Transitional Cell, Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gabrail Cancer Center, Canton, OH
Transitional Cell, Carcinoma+10 More
ACR-368 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or in combination with low dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.

Eligible Conditions

  • Platinum-resistant Ovarian Cancer (PROC)
  • Endometrial Adenocarcinomas
  • Transitional Cell, Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: Response will be assessed every 8 weeks from baseline through 2 years or death.

Year 2
Arm 1: Adverse Events (AEs) for ACR-368 monotherapy
Arm 2 Phase 1b: Adverse Events (AEs) for ACR-368 in combination with LDG
Day 28
Arm 2 Phase 1b: Determine the RP2D of LDG
Week 8
Arm 1: Number of subjects with confirmed OncoSignature thresholds for enrichment of ACR-368 monotherapy responders
Day 15
Arm 1: Limited pharmacokinetic (PK) testing in participants with Ovarian Carcinoma
Arm 2: Limited pharmacokinetic (PK) testing of ACR-368 in combination with LDG in all participants in Phase 1b
Day 15
Relative dose intensity of ACR-368
Year 2
Arm 1 Monotherapy: Anti-tumor activity of ACR-368 in Ovarian, Endometrial, and Urothelial Cohorts
Arm 2 Exploratory Phase 2: Anti-tumor activity of ACR-368 plus LDG in Ovarian, Endometrial and Urothelial Cohorts
Up to 2 years
Duration of Response (DOR)
Overall Survival (OS)
Progression-free Survival (PFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

OncoSignature Positive Tumors
1 of 2
OncoSignature Negative or Unevaluable test
1 of 2
Experimental Treatment

333 Total Participants · 2 Treatment Groups

Primary Treatment: ACR-368 · No Placebo Group · Phase 1 & 2

OncoSignature Positive TumorsExperimental Group · 2 Interventions: OncoSignature, ACR-368 · Intervention Types: DiagnosticTest, Drug
OncoSignature Negative or Unevaluable testExperimental Group · 3 Interventions: OncoSignature, Gemcitabine, ACR-368 · Intervention Types: DiagnosticTest, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2940

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: response will be assessed every 8 weeks from baseline through 2 years or death.
Closest Location: Gabrail Cancer Center · Canton, OH
Photo of ohio 1Photo of ohio 2Photo of ohio 3
2007First Recorded Clinical Trial
1 TrialsResearching Transitional Cell, Carcinoma
112 CompletedClinical Trials

Who is running the clinical trial?

GOG FoundationNETWORK
26 Previous Clinical Trials
11,321 Total Patients Enrolled
Acrivon TherapeuticsLead Sponsor
Jung-Min Lee, MDPrincipal InvestigatorNational Cancer Institute (NCI)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 years of age or older at time of consent.
Participants must have an Eastern Cooperative Oncology Group Performance Status 0 or 1.
You have histologically confirmed, locally advanced (ie, not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
You are willing to donate tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated.
You are willing to provide an archival tumor tissue block or at least 20 unstained slides, if available.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.