Trials / Active Not Recruiting
Active Not RecruitingNCT04699188
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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 344 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- KRAS G12C Mutant Solid Tumors
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Colorectal
- Cancer of Lung
- Cancer of the Lung
- Lung Cancer
- Neoplasms, Lung
- Neoplasms, Pulmonary
- Pulmonary Cancer
- Pulmonary Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JDQ443 | KRAS G12C inhibitor |
| DRUG | TNO155 | SHP2 inhibitor |
| BIOLOGICAL | tislelizumab | Anti PD1 antibody |
Timeline
- Start date
- 2021-02-24
- Primary completion
- 2027-01-25
- Completion
- 2027-01-25
- First posted
- 2021-01-07
- Last updated
- 2026-03-18
Locations
38 sites across 16 countries: United States, Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04699188. Inclusion in this directory is not an endorsement.