Clinical trial · Interventional
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine: * People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. * People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Cancer (Part 1) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| binimetinib | Drug | Binimetinib | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin | Drug | Leucovorin | ALIAS |
| midazolam | Drug | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| PF-07799933 | Drug | Claturafenib | ALIAS |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Monotherapy dose escalation (Part 1)
- description
- Participants will receive PF-07799933
- interventionNames
- Drug: PF-07799933
- type
- EXPERIMENTAL
- label
- Combination dose escalation (Part 2)
- description
- Participants will receive PF-07799933 in combination with binimetinib or cetuximab
- interventionNames
- Drug: PF-07799933
- Drug: binimetinib
- Biological: cetuximab
- type
- EXPERIMENTAL
- label
- Dose expansion (Part 3) - Tumor and mutation specific Cohort 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
This study is seeking participants who meet the following key eligibility criteria: Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor including primary brain tumor. * Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid \[DNA\], or ctDNA). * Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)). * Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies * Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required. * Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor/EGFR inhibitor allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy. * Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor/EGFR inhibitors allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy. Exclusion Criteria: * Brain metastasis larger than 4 cm * Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment. * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease. * Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).
References
Publications (0)
Data not yet available