A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors

Study Purpose

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine.

- In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib.

Encorafenib comes as a capsule and is taken once per day.

- In the second part of the study, people with melanoma or other cancers with abnormalities in a gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07799933).

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation.

- Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation.

- For Substudy B, histological or cytological diagnosis of advanced/metastatic melanoma.

- For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to SOC, excluding melanoma, - For Substudy B and C, measurable disease by RECIST version 1.1.

- For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in tumor tissue and/or blood.

- For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF alteration)
Exclusion Criteria:
- Brain metastasis larger than 4 cm.

- History or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05538130
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Glioma, Thyroid Cancer, Non-Small Cell Lung Cancer, Malignant Neoplasms, Brain Neoplasms, Colorectal Cancer
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Monotherapy Dose Escalation (Phase 1a)

Participants will receive PF-07799544

Experimental: Phase 1b Substudy B Combination Dose Escalation

Participants will receive PF-07799544 and PF-07799933

Experimental: Phase 1b Substudy B Combination Dose Expansion

Participants will receive PF-07799544 and PF-07799933

Experimental: Phase 1b Substudy C Combination Dose Expansion

Participants will receive PF-07799544 and PF-07799933

Interventions

Drug: - PF-07799544

Tablet

Drug: - PF-07799933

Tablet

Drug: - encorafenib

Capsule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Highlands Oncology Group, PA, Fayetteville, Arkansas

Status

Recruiting

Address

Highlands Oncology Group, PA

Fayetteville, Arkansas, 72703

Site Contact

Clinical Trial Finder