Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADI-212 · 1 trial · 1 indication
The primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed Dose (MAD) and Recommended Phase 2 Dose (RP2D)
This primary endpoint will be used to determine Overall Response Rate (ORR) per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 per local assessment and Radiographic progression-free survival (rPFS)
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | ADI-212 is administered via infusion using the 3 + 3 design starting with three planned dose levels to determine the maximum tolerated dose (MTD or maximum assessed dose (MAD) |
| Dose Expansion | EXPERIMENTAL | Dose Expansion to assess the anti-tumor responses to ADI-212 at the recommended Phase 2 dose (Part 2) |
| Name | Type | Description |
|---|---|---|
| ADI-212 | DRUG | Allogeneic cell therapy |
| Fludarabine | DRUG | Chemotherapy for Lymphodepletion |
| Cyclophosphamide | DRUG | Chemotherapy for Lymphodepletion |
Inclusion Criteria: * Histologic and/or cytologic confirmation of adenocarcinoma of the prostate * Documented evidence of metastatic disease. * Target lesions must be PSMA-avid by PET/CT, based on local determination. * Must have castration testosterone level (\< 50 ng/dL) and must remain on androg...
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ADI-212 is an investigational small molecule being developed for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development and has not been approved by the FDA.
ADI-212 is being developed by Adicet Bio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACET. The company is conducting a Phase 1/2 clinical trial to evaluate the drug in patients with metastatic prostate cancer.
ADI-212 is in Phase 1 clinical development. A Phase 1/2 trial is currently listed as not yet recruiting, with an enrollment target of 12 participants. The drug is investigational and has not received FDA approval.
ADI-212 is being evaluated in a Phase 1/2 trial with the identifier NCT07793435, titled 'A Phase 1/2 Trial of ADI-212 in mCRPC.' The study is not yet recruiting, plans to enroll 12 male patients aged 18 years and older, and is being conducted in the United States.
No alternative names for ADI-212 have been disclosed. The drug is identified solely by its development code ADI-212 and is being studied under the clinical trial identifier NCT07793435.