Status:
RECRUITING
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
Lead Sponsor:
Pfizer
Conditions:
Melanoma
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
16+ years
Phase:
PHASE1
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- This study is seeking participants who meet the following key eligibility 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
- 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).
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 5 2030
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT05355701
Start Date
July 5 2022
End Date
April 5 2030
Last Update
January 7 2026
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
3
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
4
Clinical and Translational Research Center (CTRC)
Aurora, Colorado, United States, 80045