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Closed (no longer recruiting)Last updated: 15 August 2024

This Phase Ib/II trial is seeking to determine the recommended dose, and then the safety and effectiveness, of a new targeted therapy (JDQ443) alone, and in combination with other targeted therapies (TNO155 and spartalizumab) in people with advanced solid cancersA Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Clinical summary

Summary

This is an open-label, non-randomised dose escalation trial with four Experimental Arms for people with advanced solid cancers harbouring the KRAS G12C Mutation. In Experimental Arm A, participants will receive JDQ443 alone. In Experimental Arm B, participants will receive JDQ443 in combination with TNO115. In Experimental Arm C, participants will receive JDQ443 in combination with spartalizumab. In Experimental Arm D, participants will receive JDQ443 in combination with TNO155 and spartalizumab.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Eligibility

Inclusion

  • Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
  • ECOG Performance Status of 0 or 1
  • At least one measurable lesion as defined by RECIST 1.1
  • Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion

Exclusion

  • Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
  • Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
  • Clinically significant cardiac disease or risk factors at screening
  • A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply.

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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