Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
STAR0602 · 1 trial · 2 indications
Proportion of participants who have a complete response (CR) or partial response (PR)
| Arm | Type | Description |
|---|---|---|
| Phase 1 Safety Run-In: Advanced Solid Tumors | EXPERIMENTAL | Interventions: STAR0602 + Sacituzumab Govitecan |
| Phase 2 Cohort Expansion: Advanced Solid Tumors | EXPERIMENTAL | Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1 |
| Name | Type | Description |
|---|---|---|
| STAR0602 | DRUG | solution, intravenous infusion |
| Sacituzumab Govitecan (SG) | DRUG | intravenous infusion, 10mg/kg |
Inclusion Criteria: 1. Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers. 2. Tumor Type: * mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC ...
STAR0602, also known as Invikafusp Alfa, is an investigational small molecule being studied for the treatment of triple negative locally advanced non-resectable breast cancer. It is also being evaluated in combination with sacituzumab govitecan for advanced solid tumors, including HR+, HER2- advanced breast cancer.
STAR0602 is a selective T cell receptor (TCR)-targeting, bifunctional antibody-fusion molecule. It is designed to target T cell receptors, which are part of the immune system's response against cancer cells. This mechanism is being investigated in the context of advanced solid tumors.
STAR0602 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational drug for oncology indications.
STAR0602 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to evaluate its safety and efficacy.
STAR0602 is being studied in a Phase 1 clinical trial with the identifier NCT06827613. This trial is recruiting 50 participants with triple negative locally advanced non-resectable breast cancer and HR+, HER2- advanced breast cancer. The study is being conducted in the United States and Canada.
Yes, STAR0602 is also known as Invikafusp Alfa. Both names refer to the same investigational drug being developed by cbdMD, Inc. The clinical trial NCT06827613 uses the name Invikafusp Alfa (STAR0602) to describe the study drug.