InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 4 April 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

Use the hyperlinks, where available to access additional clinical trial information.

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 are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

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

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.