Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

This Phase 2 study is testing an experimental drug called ACR-368 for people with high-grade endometrial adenocarcinoma (a type of uterine cancer). Researchers want to see how well ACR-368 works, either alone or with a very low dose of gemcitabine (another drug that may make cancer cells more sensitive to treatment). You could be eligible if you are an adult woman with this type of cancer. The study aims to enroll about 350 participants. Success will be measured by how much the tumors shrink or stop growing over time. The current status of the study is unclear.

Study design
This is an open-label Phase 2 study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll about 350 participants.
What's involved
You would receive treatment until your disease gets worse, you experience unacceptable side effects, or you withdraw from the study. Tumor response will be checked every 8 weeks for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Your tumor response will be assessed every 8 weeks from the start of the study through 2 years or until death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05548296

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Acrivon Therapeutics
~350 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:ACR-368GemcitabineOncoSignature

At a glance

Recruiting sites
59 of 90 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Arm 1: Anti-tumor activity of ACR-368 in Endometrial cancer subjects that are OncoSignature Positive.
Measured over Response will be assessed every 8 weeks from baseline through 2 years or death.
+3 more outcomes measured
Endometrial Adenocarcinoma
90 sites across 35 states
California9
Italy7
Spain7
New York5
Ohio5
Washington5
Illinois4
Texas4
  • Panagiotis Konstantinopoulos, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute (DFCI)
  • Isabelle Ray-Coquard, MD · PRINCIPAL_INVESTIGATOR · Centre Leon Berard

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  • Arm 1: Anti-tumor activity of ACR-368 in Endometrial cancer subjects that are OncoSignature Positive.Response will be assessed every 8 weeks from baseline through 2 years or death.

    Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

  • Arm 2: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects that are OncoSignature Negative.Response will be assessed every 8 weeks from baseline through 2 years or death.

    Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

  • Arm 3: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).Response will be assessed every 8 weeks from baseline through 2 years or death.

    Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.

  • Arm 4: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).Response will be assessed every 8 weeks from baseline through 2 years or death.

    Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic