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Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Status
Active
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04699188
Protocol IDs
CJDQ443A12101 (primary)
NCI-2021-01594
Study Sponsor
Novartis Pharmaceuticals Corporation

Summary

This is a phase Ib/II open label study. The escalation part will characterize the safety
and tolerability of JDQ443 single agent and JDQ443 in combination with the other study
treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the
determination of the maximum tolerated dose / recommended dose for a particular treatment
arm, dose expansion will assess the anti-tumor activity and further assess the safety,
tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose
or lower dose.

Eligibility

  1. 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
  2. ECOG Performance Status of 0 or 1
  3. At least one measurable lesion as defined by RECIST 1.1
  4. Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion
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Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.