Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA UCSD
Dates
study started
completion around
Principal Investigator
by Ramez Eskander, MD (ucsd)Nataliya Mar, MD (uci)Hui Chen, MD (ucdavis)Alexandra Drakaki, MD (ucla)

Description

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 ultralow dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.

Official Title

A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination With Gemcitabine in Adult Subjects With Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status

Details

Participants will be selected for predicted efficacy of ACR-368 using the OncoSignature® Companion Diagnostic test. Participants will be allocated to one of 2 arms based on OncoSignature result:

Arm 1: OncoSignature Positive tumors

Arm 2: OncoSignature Negative

Participants in Arm 1 will receive ACR-368 as monotherapy. Participants in Arm 2 will receive the combination of ACR-368 and ultralow-dose gemcitabine. Participants in both arms will be treated until disease progression, unacceptable toxicity or any criterion for stopping the study drug or withdrawal from the trial occurs.

Keywords

Platinum-resistant Ovarian Cancer, Endometrial Adenocarcinoma, Urothelial Carcinoma, Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasm, Urogenital Neoplasm, Endometrial Cancer, Endometrial Neoplasm, Ovarian Cancer, Ovarian Neoplasm, Ultralow dose gemcitabine, Platinum-resistant Ovarian Carcinoma, Carcinoma, Adenocarcinoma, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Transitional Cell Carcinoma, Uterine Neoplasms, Endometrial Neoplasms, Gemcitabine, Prexasertib, ACR-368, OncoSignature, OncoSignature Positive Tumors, OncoSignature Negative

Eligibility

Locations

Lead Scientists at University of California Health

  • Ramez Eskander, MD (ucsd)
    Clinical Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 104 research publications
  • Nataliya Mar, MD (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 36 research publications
  • Hui Chen, MD (ucdavis)
    Assistant Professor, Med: Obstetrics & Gynecology, School of Medicine
  • Alexandra Drakaki, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 115 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acrivon Therapeutics
Links
Related Info
ID
NCT05548296
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 390 study participants
Last Updated