Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-85738 · 1 trial · 3 indications
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporarily associated with the use of study treatment, whether considered related to study treatment or not. An SAE is any untoward medical occurrence that, at any dose, * Results in death * Is life-threatening * Requires hospitalization or prolongation of existing hospitalization * Results in disability/incapacity * Is congenital anomaly/birth defect * Is considered a significant medical AE by the investigator based on medical judgement
MTD is defined as the highest dose level with the target DLT closest but not exceeding 0.33. MAD is defined as the maximum administered dose and it is used when MTD is not reached.
ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). * CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. * PR: A ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Part A- Monotherapy Dose escalation and safety | EXPERIMENTAL | Ascending dose levels of BG-85738 will be evaluated as monotherapy in participants with advanced or metastatic solid tumors with RAS mutations. |
| Phase 1a: Part B - Combination therapy Dose escalation | EXPERIMENTAL | Sequential dose levels of BG-85738, selected based on Part A data, will be evaluated in combination with tislelizumab or in combination with cetuximab. |
| Phase 1b: Part C- Monotherapy dose expansion | EXPERIMENTAL | Participants with selected tumor types will receive BG-85738 monotherapy at the RDFE(s) identified in Phase 1a Part A. |
| Phase 1b: Part D - Combination therapy dose expansion | EXPERIMENTAL | Participants with select tumor types will receive BG-85738 in combination with tislelizumab or in combination with cetuximab at the RDFE(s) identified in Phase 1a Part B |
| Name | Type | Description |
|---|---|---|
| BG-85738 | DRUG | Administered orally |
| Tislelizumab | DRUG | Administered intravenously |
| Cetuximab | DRUG | Administered intravenously |
Inclusion Criteria: Participants are eligible to be included in the study only if they meet all the following criteria: * Participants must sign the informed consent form and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in t...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 2 | PHASE1 | AN9025, AN4035 |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| BeOne Medicines Ltd. Sponsored ADR | ONC | 1 | PHASE1 | BG-85738, Tislelizumab |
BG-85738 is an investigational small molecule developed by BeOne Medicines Ltd. for advanced or metastatic solid tumors that carry RAS mutations. It is being studied as a first-in-human therapy, both as a single agent and in combination with other antitumor agents, in adult patients with these biomarker-selected cancers.
BG-85738 is being evaluated for the treatment of advanced or metastatic solid tumors with rat sarcoma virus (RAS) mutations. It is an investigational agent and has not been approved for any indication. The ongoing study enrolls adults aged 18 years and older with RAS-mutated disease.
BG-85738 is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is running the first-in-human clinical program for this small molecule in patients with RAS-mutated advanced or metastatic solid tumors.
BG-85738 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 1 first-in-human study is currently recruiting participants and is designed to enroll approximately 100 patients.
BG-85738 is being studied in one active clinical trial, NCT07746141, titled a first-in-human study investigating BG-85738 alone or in combination with other antitumor agents in patients with advanced or metastatic solid tumors with RAS mutations. The trial is recruiting, is controlled, and is being conducted in Australia.