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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05415072 | A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas | PHASE1 | ACTIVE NOT_RECRUITING | 66 | — | — | Jul 4, 2022 | Oct 1, 2027 | Jul 20, 2025 | 11 | United States, Australia +5 |
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with DYP688. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Assessment of safety of DYP688 as a single agent
Assessment of tolerability of DYP688 as a single agent
ORR in Phase II will be evaluated by central review per RECIST 1.1.
| Arm | Type | Description |
|---|---|---|
| Phase I: Dose Escalation | EXPERIMENTAL | Patients with metastatic uveal melanoma or other GNAQ/11 mutant melanomas |
| Phase II: Tebe naive group | EXPERIMENTAL | Patients with metastatic uveal melanoma that has not received prior treatment with tebentafusp |
| Phase II: Tebe pre-treated | EXPERIMENTAL | Patients with metastatic uveal melanoma that have been previously treated with tebentafusp |
| Phase II: Non-uveal melanoma | EXPERIMENTAL | Optional Arm: To explore patients with non-uveal melanoma that harbor GNAQ or 11 mutations, based on emerging data from dose escalation |
| Name | Type | Description |
|---|---|---|
| DYP688 | DRUG | Single agent DYP688 |
Inclusion Criteria: * Patients in the dose escalation part must be ≥ 18 years of age at the time of informed consent (ICF) signature. In the phase II part, patients ≥ 12 years of age at the time of informed consent may be eligible for enrollment (not applicable in countries where enrollment is rest...