A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
NCT04294160 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2025-12-24
Summary
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
Conditions
- BRAF V600 Colorectal Cancer
Interventions
- DRUG
-
Dabrafenib
Capsule for oral use
- DRUG
-
LTT462
Capsule for oral use
- DRUG
-
Trametinib
Tablet for oral use
- DRUG
-
LXH254
Tablet for oral use
- DRUG
-
TNO155
Capsule for oral use
- BIOLOGICAL
-
Spartalizumab
Liquid in vial (Concentrate for solution for infusion) for intravenous use
- BIOLOGICAL
-
Tislelizumab
Liquid in vial (Concentrate for solution for infusion) for intravenous use
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-22
- Primary Completion
- 2024-09-25
- Completion
- 2024-09-25
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Canada
- Germany
- Israel
- Netherlands
- Singapore
- Spain
- United Kingdom
Study Locations
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