NCT04699188Active, not recruitingPhase 1/2
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 344 (actual)
- First submitted
- 5 Jan 2021
- Start date
- 24 Feb 2021
- Primary completion date
- 25 Jan 2027
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT04699188
- EudraCT number
- 2020-004129-22
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 344
- From 24 Feb 2021 to the primary completion date, 25 Jan 2027
- 36 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.