Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18 - 99
Clinical summary
Summary
This study involves two parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion/Optimisation.
Phase 1a Dose Escalation aims to are to evaluate safety and tolerability, and recommend a phase 1b dose (RP1bD) of the combination of BBP-398 + sotorasib. In this phase, participants will be randomly assigned to cohorts to receive specific doses of BBP-393 (administered as daily capsules) in combination with sotorasib (daily tablets).
Phase 1b Dose Expansion/Optimisation aims to evaluate the safety, tolerability and effectivness of BBP-398 + sotorasib across two dose regimens in patients with advanced or metastatic non-small cell lung cancer with KRAS-G12C mutation and who are KRAS-G12Ci naïve, and recommend a phase 2 dose (RP2D) of the combination.
Conditions
This trial is treating people with advanced solid cancers
Eligibility
Inclusion
- Patients must have histologically documented, locally advanced and unresectable, or metastatic solid tumor with documentation of a KRAS-G12C mutation within 2 years prior to screening.
- Patients must have measurable disease by RECIST v1.1.
- Patients must have a minimum life expectancy of >12 weeks after start of study treatment.
- Patients must have progression or disease recurrence on or after all available standard of care therapies.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- Patients must have adequate organ function.
Exclusion
- Patients that have participated in an interventional clinical study within the last 4 weeks.
- Patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, OR radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment.
- Patients with untreated and/or active CNS metastases.
- Patients that have a history of allogenic bone marrow transplant.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Navire Pharma Inc., a BridgeBio company
Scientific Title
A Phase 1 Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Combination With the KRAS-G12C Inhibitor Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
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