Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DYP688 · 1 trial · 1 indication
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...
DYP688 is an investigational small molecule being developed for the treatment of metastatic uveal melanoma, a rare form of eye cancer that has spread to other parts of the body. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
DYP688 is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of DYP688 in patients with metastatic uveal melanoma.
DYP688 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of DYP688 in patients with metastatic uveal melanoma.
DYP688 is being studied in a Phase 1/II clinical trial with the identifier NCT05415072. This trial is actively recruiting participants and is expected to enroll approximately 66 patients with metastatic uveal melanoma and other GNAQ/11 mutant melanomas. The study is being conducted across multiple countries, including the United States, Australia, France, Germany, Netherlands, Spain, and Switzerland.
DYP688 is a unique investigational compound and is not known to be the same as any other approved drug. It is a small molecule being studied specifically for its potential to treat metastatic uveal melanoma. As it is still in clinical development, it does not have any alternative brand names or generic names.