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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07541573 | GTB-5550 in Advanced Solid Tumors | PHASE1 | RECRUITING | 175 | — | — | Apr 8, 2026 | Jan 1, 2032 | Apr 23, 2026 | 1 | United States |
The primary objective is to identify one of the six dose-level strategies of GTB-5550 (cam anti-CD16/WT IL 15/cam anti-B7-H3 TriKE) that corresponds to the desired maximum toxicity rate of less of equal to 20%, defining the MTD.
| Arm | Type | Description |
|---|---|---|
| Dose Level Cohort -1 | EXPERIMENTAL | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 90 µg (or 20 µL) of GTB-5550. |
| Dose Level Cohort 1 | EXPERIMENTAL | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 270 µg (or 60 µL) of GTB-5550. |
| Dose Level Cohort 2 | EXPERIMENTAL | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 900 µg (or 200 µL) of GTB-5550. |
| Dose Level Cohort 3 | EXPERIMENTAL | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 2700 µg (or 600 µL) of GTB-5550. |
| Dose Level Cohort 4 | EXPERIMENTAL | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 5400 µg (or 1200 µL) of GTB-5550. |
| Dose Level Cohort 5 | EXPERIMENTAL | Patients with histologically or cytologically confirmed advanced/metastatic cancer. Patients will receive 9000 µg (or 2000 µL) of GTB-5550. |
| Name | Type | Description |
|---|---|---|
| GTB-5550 | DRUG | GTB-5550 is given as a subcutaneous (SQ) injection in the abdominal area at the patient-assigned dose once a day for 5 consecutive days for 2 weeks in a row (i.e. Day 1-5 and Day 8-12) followed by 2 weeks of no treatment. This 4-week period equals 1 treatment cycle, or 28 days. Starting with Cycle 2 and beyond, this will be repeated with three times per week dosing for weeks 1 and 2 of the cycle (but not on 3 consecutive days) followed by 2 weeks of no treatment. |
Inclusion Criteria: * Measurable disease per RECIST 1.1. (Exception: mCRPC limited to bone metastasis is exempt from this requirement). * Age 18 years or older at the time of consent, ECOG Performance Status 0 to 2 * Acute effects of any prior therapy must have resolved to baseline or Grade ≤ 1 NCI...