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Study of JDQ443 in advanced cancer with a specific mutation (G12C) of the KRAS gene
EU CTIS ID: 2023-508073-87-00
What this study is testing
Dose Escalation To assess the safety and tolerability of JDQ443 single agent and JDQ443 in combination with TNO155, JDQ443 in combination with tislelizumab, and JDQ443 in combination with TNO155 and tislelizumab, and to identify the maximum tolerated dose and/or recommended dose and regimen for future studies. Dose Expansion To evaluate the overall response rate (ORR) for JDQ443 single agent and JDQ443 in combination with TNO155, JDQ443 in combination with tislelizumab, and JDQ443 in combination with TNO155 and tislelizumab. To evaluate the preliminary overall intracranial response rate (OIRR) of JDQ443 single agent (brain metastasis group only) To evaluate the preliminary safety/tolerability and anti-tumor activity of JDQ443 single agent in patients with NSCLC (JDQ443 dose randomization group only)
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Dose Escalation: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are intolerant or ineligible to approved therapies.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy. Treatment with a prior KRAS G12C inhibitor is not allowed.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy, and one treatment line of a direct KRAS G12C inhibitor given as a single agent and discontinued within 6 months of the first day of study treatment.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant NSCLC who have received a platinum-based chemotherapy regimen and an immune checkpoint inhibitor therapy either in combination or in sequence, unless patient was ineligible to receive such therapy. The patient must have at least one untreated brain metastasis. Treatment with a prior KRAS G12C inhibitor is not allowed.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received standard-of-care therapy, including a fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy. Treatment with a prior KRAS G12C inhibitor is not allowed.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors other than NSCLC or CRC who have received standard of care therapy or are intolerant or ineligible to approved therapies. Treatment with a prior KRAS G12C inhibitor is not allowed.
You likely can't join if
- 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 the single agent dose escalation arm and a subset of groups in dose expansion.
- Prior treatment with a SHP2 or SOS1 inhibitor is not allowed for NSCLC patients enrolled into the dose expansion parts of the JDQ443 single agent and JDQ443 plus TNO155 expansion arms.
- Untreated brain metastases (applicable to all patients except the brain metastasis group), symptomatic brain metastases (applicable to all patients), or known leptomeningeal disease (applicable to all patients), or known leptomeningeal disease (applicable to all patients).
- Clinically significant cardiac disease or risk factors at screening
- Insufficient bone marrow, hepatic or renal function at screening
See the full eligibility criteria
- Dose Escalation: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are intolerant or ineligible to approved therapies.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy. Treatment with a prior KRAS G12C inhibitor is not allowed.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received a platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy, and one treatment line of a direct KRAS G12C inhibitor given as a single agent and discontinued within 6 months of the first day of study treatment.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant NSCLC who have received a platinum-based chemotherapy regimen and an immune checkpoint inhibitor therapy either in combination or in sequence, unless patient was ineligible to receive such therapy. The patient must have at least one untreated brain metastasis. Treatment with a prior KRAS G12C inhibitor is not allowed.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received standard-of-care therapy, including a fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy. Treatment with a prior KRAS G12C inhibitor is not allowed.
- Dose Expansion: • Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors other than NSCLC or CRC who have received standard of care therapy or are intolerant or ineligible to approved therapies. Treatment with a prior KRAS G12C inhibitor is not allowed.
- All Patients: • ECOG performance status of 0 or 1.
- All Patients: • 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.
- 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 the single agent dose escalation arm and a subset of groups in dose expansion.
- Prior treatment with a SHP2 or SOS1 inhibitor is not allowed for NSCLC patients enrolled into the dose expansion parts of the JDQ443 single agent and JDQ443 plus TNO155 expansion arms.
- Untreated brain metastases (applicable to all patients except the brain metastasis group), symptomatic brain metastases (applicable to all patients), or known leptomeningeal disease (applicable to all patients), or known leptomeningeal disease (applicable to all patients).
- Clinically significant cardiac disease or risk factors at screening
- Insufficient bone marrow, hepatic or renal function at screening
The study team makes the final eligibility decision.
Where it's taking place
- China
- Singapore
- Taiwan
- Korea, Republic of
- Australia
- Hong Kong
- Canada
- Japan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Singapore; Taiwan; Korea, Republic of; Australia; Hong Kong and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.