Status:
TERMINATED
PF-07284892 in Participants With Advanced Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lor...
Eligibility Criteria
Inclusion
- Age ≥18 years at the time of informed consent
- Histological or cytological diagnosis of ALK-positive advanced NSCLC, CRC with BRAF V600E mutation, or RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumor. Participants with ROS-positive NSCLC are also eligible for Part 1 and 2 (Other ROS1-positive solid tumors may be considered after discussion with the sponsor).
- Documentation evidence of biomarker mutation status
- Part 3:
- ALK-positive NSCLC with prior lorlatinib and no prior platinum-based chemotherapy (Cohort 1); with prior lorlatinib and prior platinum-based chemotherapy (Cohort 2); or with no prior lorlatinib (Cohort 3).
- BRAF V600E mutant CRC participants resistant to BRAFi plus EGFRi (Cohort 4 ); refractory to BRAFi plus EGFRi (Cohort 5); or BRAFi plus EGFRi naïve (Cohort 6).
- RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior SOC (Cohort 7).
Exclusion
- Brain metastasis larger than 4 cm
- Active malignancy within 3 years
- Systemic anti-cancer therapy or small molecule therapeutics within 2 weeks prior to start of study treatment. Antibody based agents within 4 weeks prior to start of study treatment. Mitomycin C or nitrosoureas within 6 weeks prior to start of study treatment.
- For participants who may get lorlatinib or encorafenib on study, history of interstitial lung disease
- For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04800822
Start Date
March 17 2021
End Date
June 19 2024
Last Update
October 22 2024
Active Locations (19)
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1
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States, 85054
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
California Cancer Associates for Research and Excellence
Encinitas, California, United States, 92024
4
California Cancer Associates for Research and Excellence
San Marcos, California, United States, 92069