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Also known as prexasertib
ACR-368 · 1 trial · 1 indication
Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic
| Arm | Type | Description |
|---|---|---|
| OncoSignature Positive Tumors | EXPERIMENTAL | ARM 1: Participants with OncoSignature Positive Tumors will enter a Phase 2 Simon 2-Stage Study that will assess the efficacy of ACR-368 as monotherapy. |
| OncoSignature Negative Tumors | EXPERIMENTAL | Arm 2: Participants with OncoSignature Negative Tumors will receive ACR-368 with ULDG sensitization. The Phase 2 Study will assess the efficacy and safety of ACR-368 with ULDG sensitization. |
| OncoSignature Unselected (Serous All-Comers) ACR-368 with ULDG | EXPERIMENTAL | Arm 3: Participants who are OncoSignature Unselected will receive ACR-368 with ULDG sensitization. The Phase 2 Study will assess the efficacy and safety of ACR-368 with ULDG sensitization. |
| OncoSignature Unselected (Serous All-Comers) ACR-368 | EXPERIMENTAL | Arm 4: Participants who are OncoSignature Unselected will receive ACR-368. The Phase 2 Study will assess the efficacy and safety of ACR-368. |
| Name | Type | Description |
|---|---|---|
| ACR-368 | DRUG | ACR-368 is an experimental drug |
| Gemcitabine | DRUG | Sensitization of tumor cells is provided through administration of ULDG |
| OncoSignature | DIAGNOSTIC_TEST | Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy |
Inclusion Criteria: General 1. Participant must be able to give signed, written informed consent. 2. Participant must have histologically documented, high-grade endometrial cancer. Arms 1 and 2 1. All high-grade epithelial endometrial histological subtypes are eligible including: endometrioi...
ACR-368 is an investigational small molecule being studied for the treatment of endometrial adenocarcinoma, a type of endometrial cancer. It is being developed by Acrivon Therapeutics, Inc. and is currently in Phase 2 clinical development. It has not been approved by the FDA for any indication.
ACR-368 is being developed by Acrivon Therapeutics, Inc., which trades on the Nasdaq under the ticker ACRV. The company is running a Phase 2 study of the drug in endometrial adenocarcinoma across sites in the United States, France, Germany, Italy, and Spain.
ACR-368 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 study is currently recruiting participants and has an planned enrollment of 350 patients.
ACR-368 is being evaluated in a single Phase 2 study, NCT05548296, titled A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma. The trial is currently recruiting, with an planned enrollment of 350 female participants aged 18 years and older across the United States, France, Germany, Italy, and Spain.
Yes. ACR-368 has received both Breakthrough Therapy and Fast Track designations from the FDA for its development in endometrial adenocarcinoma. These designations are intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.
The Phase 2 trial NCT05548296 is enrolling female participants aged 18 years and older with endometrial adenocarcinoma. It is a controlled study that is not randomized and not double-blind, and it does not enroll healthy volunteers. The study is recruiting at sites across the United States and several European countries.