This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
Dose Escalation:
\- Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy.
Phase II:
* Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
* Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy.
All patients:
* ECOG performance status of 0 or 1.
* Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines.
Exclusion Criteria:
* Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
* Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II.
* Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease
* Clinically significant cardiac disease or risk factors at screening
* Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply
Primary outcome measure(s)
Dose escalation: Incidence and severity of dose limiting toxicities (DLTs) of each combination treatment. — 28 days A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that is not primarily related to disease, disease progression, intercurrent illness/injury, or concomitant medications that occurs within the first 28 days of study treatment and meets a defined criteria.
Dose escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment — 24 months All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).
Dose escalation: Frequency of dose interruptions and reductions, by treatment — 24 months The number of patients with dose adjustments (reductions and interruptions) will be summarized by treatment group.
Dose Escalation: Dose intensity by treatment — 24 months Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of response.
PhaseII: Overall Response Rate by Blinded Independent Review Committee (BIRC) per RECIST 1.1 — 24 months ORR is the proportion of patients with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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