Clinical Trials in Australia / NCT07746141
Recruiting
Phase 1
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 Rat Sarcoma Virus (RAS) Mutations
NCT07746141 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
RAS MutationAdvanced Solid TumorMetastatic Solid Tumor
Investigational drug(s) / intervention(s)
BG-85738: Administered orally
Tislelizumab: Administered intravenously
Cetuximab: Administered intravenously
Study summary
The purpose of this study is to test if the BG-85738 is safe and if it works in patients with advanced solid tumors with RAS mutations when it is given on its own and in combination.
Eligibility
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 the informed consent form (ICF) and in this protocol.
* Participants must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older), at the time of signing the ICF.
* Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors and meet study part and cohort-specific criteria
* Participants must have evidence of a RAS mutation defined as a nonsynonymous mutation in Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), or Harvey rat sarcoma viral oncogene homolog (HRAS) at codons 12, 13, or 61 (G12, G13, or Q61), based on testing of either tumor tissue or liquid biopsy (blood or plasma) as determined by the local laboratory
Exclusion Criteria:
Participants are excluded from the study if they meet any of the following criteria:
* Participants who have prior RAS-targeted therapy, including, but not limited to, KRAS mutation-specific inhibitors (with the exception of participants with NSCLC and colorectal cancer who received a G12C inhibitor), pan-KRAS inhibitors, and pan-RAS inhibitors.
* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment.
* Participants who are unable to comply with the requirements of the protocol.
* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastases
* Participants with any malignancy ≤ 3 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
* Participants with active hepatitis C.
* Participants with medical history of untreated Human Immunodeficiency Virus infection.
Note: Other protocol defined criteria may apply.
Primary outcome measure(s)
- Phase 1a (Part A and Part B): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 24 months
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 - Phase 1a (Parts A and B): Number of Participants with Dose Limiting Toxicity (DLT) — Up to approximately 1 month
- Phase 1a (Parts A and B): Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-85738 as monotherapy or in combination with other antitumor agents — Up to approximately 1 month
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. - Phase 1a: Recommended Dose for Expansion (RDFE) of BG-85738 — Up to approximately 1 month
- Part 1b (Parts C and D): Overall Response Rate (ORR) — Up to approximately 24 months
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. - Phase 1b Dose Expansion: Recommended Phase 2 dose (RP2D) of BG-85738 — Up to approximately 24 months
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Icon Cancer Centre South Brisbane | South Brisbane | Queensland | Recruiting |
| Cabrini Hospital Malvern | Malvern | Victoria | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07746141 on ClinicalTrials.gov ↗ ← All trials in Australia