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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07192614 | A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer | PHASE1 | RECRUITING | 52 | — | — | Sep 30, 2025 | Mar 29, 2029 | May 7, 2026 | 25 | United States, Belgium +7 |
• Number of participants with AEs, AESIs, SAEs, including AEs leading to discontinuation of study intervention and clinically significant alterations from baseline in laboratory parameters, vital signs, ECGs and physical examination results
• A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
• Number of participants with a PSA response rate
| Arm | Type | Description |
|---|---|---|
| Module 1 - Part A (Dose Escalation) | EXPERIMENTAL | AZD6621 Monotherapy - Administration route 1 |
| Module 2 - Part A (Dose Escalation) | EXPERIMENTAL | AZD6621 Monotherapy - Administration route 2 |
| Module 1/2 - Part B1 (Dose Expansion) | EXPERIMENTAL | AZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1) |
| Module 1/2 - Part B2 (Dose Expansion) | EXPERIMENTAL | AZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2) |
| Name | Type | Description |
|---|---|---|
| AZD6621 | DRUG | A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8 |
Inclusion Criteria 1. Capable of giving signed informed consent and complying to the study protocol. 2. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form. 3. ≥ 18 years of age at the time of signing the informed consent form. 4. Participants wi...