A Study of ACR-368 in Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma

Active:	Yes
Cancer Type:	Ovarian Cancer Solid Tumor Unknown Primary Uterine Cancer	NCT ID:	NCT05548296
Trial Phases:	Phase I Phase II	Protocol IDs:	ACR-368-201 (GOG 3082) (primary) NCI-2022-10629
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Acrivon Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT05548296

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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