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...
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 yet been approved by regulatory authorities.
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 clinical trials of ADI-212 in the United States.
ADI-212 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing trial is a Phase 1/2 study, but the drug is currently in the Phase 1 portion.
ADI-212 is being studied in a Phase 1/2 trial with the identifier NCT07793435. This trial is enrolling 12 male patients aged 18 years and older with PSMA-positive metastatic castration-resistant prostate cancer. The study is not yet recruiting and is being conducted in the United States.
ADI-212 is the sole name provided for this investigational drug. No alternative names have been reported for this asset in its clinical development program.