Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05548296 | A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma | PHASE2 | RECRUITING | 401 | — | — | Aug 29, 2022 | Nov 30, 2027 | May 14, 2026 | 90 | United States, France +3 |
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...