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Closed (no longer recruiting)Last updated: 14 June 2024

Argonaut: This study is seeking to determine the recommended dose level, safety and effectiveness of a new cancer drug (called BBP-398) when given in addition to targeted therapy (called sotorasib) in people with advanced solid cancers with a KRAS-G12C mutationA 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

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 patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 99

Phase

I

Trial Acronym

Argonaut

More information

Trial Identifiers

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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

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.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • 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 have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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