A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
Purpose
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b). Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have: - a solid tumor which is metastatic or recurrent (excluding colorectal cancer) - tumor with the mutation (abnormal gene) called "BRAF V600" - received required prior treatment for cancer per cohort assigned. All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day. Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
Conditions
- Melanoma
- Glioma
- Thyroid Cancer
- Non-Small Cell Lung Cancer
- Malignant Neoplasms
- Brain Neoplasms
- Advanced or Metastatic Solid Tumors
- HGG
- LGG
- Low Grade Glioma
- High Grade Glioma
- Differentiated Thyroid Cancer
- NSCLC (Non-small Cell Lung Cancer)
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer) - Measurable disease by RECIST version 1.1 - Evidence of a BRAF V600 mutation - Prior therapy per tumor cohort - Adequate organ function per protocol Phase 1b
Exclusion Criteria
- Other active malignancy within 3 years - Presence of leptomeningeal disease - History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease - Concurrent neuromuscular disorder associated with elevated creatine kinase (CK) - Active gastrointestinal disease as defined per protocol - History of interstitial lung disease as defined per protocol
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1a Monotherapy Dose Escalation |
Participants will receive PF-07799544 |
|
|
Experimental Phase 1b Combination Dose Escalation |
Participants will receive PF-07799544 and PF-07799933 |
|
|
Experimental Phase 1b Combination Dose Expansion |
Participants will receive PF-07799544 and PF-07799933 |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02115
More Details
- Status
- Recruiting
- Sponsor
- Pfizer