NCT05548296

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 353 (estimated)
• Sponsor: Acrivon Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label Phase 2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or with ultra-low dose gemcitabine (ULDG) sensitization in participants with endometrial cancer.

Detailed description

OncoSignature Selected Cohorts (Arms 1 and 2): Participants in Arms 1 \& 2 will be allocated into two arms based on prospectively predicted sensitivity to ACR-368 using the OncoSignature® Companion Diagnostic test, as follows: Arm 1: OncoSignature Positive tumors Arm 2: OncoSignature Negative tumors OncoSignature Unselected Cohort (Arm 3): In Arm 3 participants will not require a biopsy or OncoSignature result. Participants in Arm 1 will receive ACR-368 as monotherapy. Participants in Arms 2 and 3 will receive ACR-368 with ULDG sensitization. Participants in all arms will be treated until disease progression, unacceptable toxicity or any criterion for stopping the study drug or withdrawal from the trial occurs. Arms 1 and 2 do not apply to sites in the European Union (EU), which will enroll subjects in Arm 3.

Conditions

• Endometrial Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ACR-368	ACR-368 is an experimental drug
DRUG	Gemcitabine	Sensitization of tumor cells is provided through administration of ULDG
DIAGNOSTIC_TEST	OncoSignature	Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy

Timeline

• Start date: 2022-08-29
• Primary completion: 2026-10-31
• Completion: 2027-04-30
• First posted: 2022-09-21
• Last updated: 2026-03-24

Locations

90 sites across 5 countries: United States, France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study
• FDA-regulated device study