Studio con JDQ443 in pazienti con tumori solidi in stadio avanzato con mutazione KRAS G12C

Phase 1

• Conditions: advanced solid tumors harboring the KRAS G12C mutation; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004129-22-IT
• Lead Sponsor: OVARTIS PHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

Dose Escalation:
• Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received and failed standard of care therapy or are intolerant or ineligible to approved therapies.
Dose Expansion:
• Advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer patients who are in the second or third line treatment setting who have received and failed a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient refused or was ineligible to receive such therapy
• Advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer patients who have received and failed standard-of-care therapy, including a fluropyrimidine-, oxaliplatin-, and / or irinotecan-based chemotherapy, unless patient refused or 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 institution's own guidelines and requirements for such procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

• Tumors harboring driver mutations that have approved therapies or
tumors with known activating KRAS, NRAS, HRAS, BRAF, or PTPN11
(SHP2) mutations, with the exception of KRAS G12C mutations.
• Prior treatment with a KRAS G12C inhibitor will be exclusionary for patients in the single agent dose escalation arm and all patients in dose expansion.
• Prior treatment with a SHP2 inhibitor is not allowed for NSCLC patients enrolled into the dose expansion parts, in the JDQ443 single agent and JDQ443 plus TNO155 expansion groups.
• Active brain metastases, i.e. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified