Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GI-102 · 1 trial · 1 indication
A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 6.0) or significant laboratory abnormality that occur during the DLT assessment periods, and is considered by the Investigator to be related to the study drug(s).
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
PSA response rate is defined as the percentage of participants with a decline of PSA of 50% or more from baseline.
| Arm | Type | Description |
|---|---|---|
| Safety run-in: GI-102 Q6W + pasritamig Q6W | EXPERIMENTAL | Participants receive GI-102 every 6 weeks (Q6W) in combination with pasritamig every 6 weeks (Q6W) during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design. |
| Safety run-in: GI-102 Q3W + pasritamig Q6W | EXPERIMENTAL | Participants receive GI-102 every 3 weeks (Q3W) in combination with pasritamig every 6 weeks (Q6W) during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design. |
| Expansion | EXPERIMENTAL | Participants enrolled in the Expansion phase will receive the combination cRP2D of GI-102 and pasritamig, with the GI-102 dosing schedule (Q3W or Q6W) selected based on the safety and dose-escalation results from the Safety run-in phase. |
| Name | Type | Description |
|---|---|---|
| GI-102 | DRUG | GI-102 will be administered via IV infusion |
| Pasritamig | DRUG | Pasritamig will be administered via IV infusion. |
Key Inclusion Criteria: * Male participants aged ≥18 years (or ≥19 years according to local regulatory requirements). * ECOG performance status of 0 to 1. * Histologically confirmed advanced prostate adenocarcinoma with measurable or evaluable disease. Adenocarcinoma with small cell or neuroendocri...