Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-C9074 · 2 trials · 4 indications
PFS is defined as the time from randomization to the date of disease progression by BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever occurs first.
Number of participants with AEs and SAEs (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] Version \[v\] 5.0),, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28% or the highest dose administered, respectively
The potential RDFE(s) of BG-C9074 alone and in combination with tislelizumab will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, PK, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
The RP2D of BG-C9074 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
| Arm | Type | Description |
|---|---|---|
| Arm A: BG-C9074 + Bevacizumab | EXPERIMENTAL | BG-C9074 will be administered first, followed by bevacizumab. |
| Arm B: Bevacizumab | ACTIVE_COMPARATOR | Bevacizumab will be administered alone. |
| Phase 1a: Part A (Monotherapy Dose Escalation) | EXPERIMENTAL | BG-C9074 monotherapy dose escalation |
| Phase 1a: Part B (Monotherapy Safety Expansion) | EXPERIMENTAL | BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated. |
| Phase 1a: Part C (Combination Therapy Dose Escalation) | EXPERIMENTAL | BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE). |
| Phase 1a: Part D (Japan Cohort) | EXPERIMENTAL | A separate cohort in Japan will evaluate the safety of BG-C9074 monotherapy in Japanese participants with select solid tumors |
| Phase 1b: Monotherapy Dose Expansion | EXPERIMENTAL | The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a. |
| Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab) | EXPERIMENTAL | This arm will assess BG-C9074 plus tislelizumab as first-line therapy in select solid tumors after completion of the dose escalation phase. |
| Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus bevacizumab) | EXPERIMENTAL | This arm will assess BG-C9074 plus bevacizumab in select solid tumors participants after establishing the recommended monotherapy dose and schedule. |
| Name | Type | Description |
|---|---|---|
| BG-C9074 | DRUG | Administered by Intravenous infusion |
| Bevacizumab | DRUG | Administered by Intravenous infusion |
| Tislelizumab | DRUG | administered by intravenous infusion |
Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. Participants must have a histologically confirmed diagnosis of epithelial ...
BG-C9074 is an investigational small molecule antibody-drug conjugate being developed by BeOne Medicines Ltd. for advanced solid tumors and epithelial ovarian cancer. It is in Phase 1 clinical development and has not been approved by the FDA. It is being studied both as a single agent and in combination with other anticancer therapies.
BG-C9074 targets B7-H4, a protein in the B7 immune checkpoint family. As an antibody-drug conjugate, BG-C9074 is designed to deliver a cytotoxic payload to cells expressing B7-H4. The Phase 1a/1b trial is biomarker-selected, enrolling patients whose tumors express the target.
BG-C9074 is being developed by BeOne Medicines Ltd., which trades on the Nasdaq under the ticker ONC. BeOne Medicines is the sponsor of the clinical program evaluating BG-C9074 in advanced solid tumors and in ovarian, fallopian tube, and primary peritoneal cancers.
BG-C9074 is in Phase 1 development for advanced solid tumors, with a Phase 3 trial planned in ovarian, fallopian tube, and primary peritoneal cancers. The Phase 3 study is not yet recruiting. BG-C9074 is investigational and has not been approved by the FDA for any indication.
BG-C9074 is being evaluated in two registered trials. NCT06233942 is a Phase 1a/1b first-in-human study in advanced solid tumors that is currently recruiting in the United States, Australia, Brazil, China, and Japan. NCT07811271 is a Phase 3 trial in ovarian, fallopian tube, or primary peritoneal cancers that is not yet recruiting.
BG-C9074 is being studied in epithelial ovarian cancer, along with fallopian tube and primary peritoneal cancers. A Phase 3 trial, NCT07811271, will compare BG-C9074 plus bevacizumab against bevacizumab alone in adult women with these cancers. The trial is not yet recruiting and BG-C9074 remains investigational.