Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BI1206 · 1 trial · 1 indication
Assess the safety and tolerability profile of increasing doses of BI-1206, administered IV or SC, in combination with pembrolizumab in subjects with advanced solid tumors
In Phase 1, identify DLTs, determine the MTD, and select a signal-seeking Phase 2a dose of BI-1206 given via IV infusion or SC injection in combination with pembrolizumab (administered at the standard dose of 200 mg every 3 weeks) to subjects with advanced solid tumors who are experiencing disease progression and have been previously treated with anti-PD-1 or anti- PD-L1 antibodies
| Arm | Type | Description |
|---|---|---|
| BI-1206 + Pembrolizumab 25mg/mL (MK-3475) | EXPERIMENTAL | BI-1206 administrated either IV or SC + Pembrolizumab 200mg administered IV every third week as a fixed dose will be used. |
| Name | Type | Description |
|---|---|---|
| BI1206 | DRUG | BI-1206 administrated either IV or SC every third week. Pembrolizumab 200mg administered IV every third week as a fixed dose will be used in Phase 1 and IIa. The mTPI2 Design will be used for both the IV and SC cohorts. ivRP2D and scRP2D to be used in Phase |
Inclusion Criteria: * Is willing and able to provide written informed consent for the trial. * Is ≥18 years of age on day of signing informed consent. * Phase I only: Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1/L1 mAb, a...
BI1206 is an investigational small molecule being studied for the treatment of advanced solid tumors in adults. It is currently in Phase 1 clinical development, evaluated in combination with pembrolizumab in patients with advanced solid tumors.
BI1206 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied in combination with pembrolizumab, an immune checkpoint inhibitor, for advanced solid tumors.
BI1206 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials.
BI1206 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in an ongoing clinical trial for advanced solid tumors.
BI1206 is being studied in one active clinical trial, NCT04219254, titled 'A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors.' This Phase 1 trial is recruiting participants and has an enrollment of 197.
No, BI1206 is not the same as pembrolizumab. BI1206 is an investigational small molecule being studied in combination with pembrolizumab, which is an established immunotherapy drug, in a clinical trial for advanced solid tumors.