Clinical trial · Interventional
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The decision of early termination was made due to business reasons, and was not based on any safety concerns for any of the treatment combinations.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF V600 Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabrafenib | Drug | Dabrafenib | ALIAS |
| LTT462 | Drug | — | UNRESOLVED |
| LXH254 | Drug | — | UNRESOLVED |
| Spartalizumab | Biological | — | UNRESOLVED |
| Tislelizumab | Biological | Tislelizumab | ALIAS |
| TNO155 | Drug | — | UNRESOLVED |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Dabrafenib + LTT462 backbone arm 1
- description
- dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
- interventionNames
- Drug: Dabrafenib
- Drug: LTT462
- type
- EXPERIMENTAL
- label
- Dabrafenib + LTT462 + trametinib triplet arm 1
- description
- dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
- interventionNames
- Drug: Dabrafenib
- Drug: LTT462
- Drug: Trametinib
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. Exceptions may be considered after documented discussion with Novartis. * All patients must have a BRAF V600 mutation confirmed by local assessment. * Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1 * Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease Key Exclusion Criteria: * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy * Impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs * History of or current evidence/risk of retinal verin occlusion or serous retinopathy * History of or current interstitial lung disease or non-infectious pneumonitis * Patients with a known history of testing positive for HIV * Clinically significant cardiac disease at screening * Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. * Pregnant or lactating women Other protocol-defined inclusion/exclusion may apply.
References
Publications (0)
Data not yet available