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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462, RMC-9805, RMC-6236, mFOLFIRINOX, gemcitabine/nab-paclitaxel |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
| Myriad Genetics, Inc. | MYGN | 1 | PHASE1 | Melphalan, BCNU, Vitamin B12B, Vitamin C |
BG-85738 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors with rat sarcoma virus (RAS) mutations. It is intended for patients with RAS-mutated cancers, a type of oncology indication. The drug is currently in Phase 1 clinical development.
BG-85738 targets cancers driven by rat sarcoma virus (RAS) mutations. It is designed to treat advanced or metastatic solid tumors that harbor these genetic alterations. The drug is being studied as a monotherapy and in combination with other antitumor agents in patients with RAS-mutated tumors.
BG-85738 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting a first-in-human study of the drug in patients with advanced or metastatic solid tumors with RAS mutations.
BG-85738 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 1 trial is a first-in-human study evaluating the drug's safety and tolerability.
BG-85738 is being studied in a Phase 1 clinical trial with the identifier NCT07746141. This first-in-human study is 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 not yet recruiting and aims to enroll 100 participants.