Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed for the treatment of endometrial adenocarcinoma, a type of cancer that forms in the lining of the uterus. It is currently being studied in a Phase 2 clinical trial for this indication.
ACR-368 is being developed by Acrivon Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ACRV. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with endometrial adenocarcinoma.
ACR-368 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 study is actively recruiting participants to evaluate its effects in endometrial adenocarcinoma.
ACR-368 is being studied in a Phase 2 clinical trial registered as NCT05548296. This trial is recruiting female patients aged 18 years and older with endometrial adenocarcinoma. The study is being conducted in the United States, France, Germany, Italy, and Spain, with a planned enrollment of 350 participants.
Yes, ACR-368 has received Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration. These designations are intended to expedite the development and review of drugs that show promise in treating serious conditions and addressing unmet medical needs.