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

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Glioma; Melanoma; Thyroid Cancer; Brain Neoplasms; Colorectal Cancer; Malignant Neoplasms; Non-Small Cell Lung Cancer

Treatments: Drug: PF-07799544; Drug: encorafenib; Drug: PF-07799933

Study type: Interventional

Funder types: Industry

Identifiers

NCT05538130

C4901001

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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124 participants in 4 patient groups

Monotherapy Dose Escalation (Phase 1a)

Experimental group

Description:

Participants will receive PF-07799544

Treatment:

Drug: encorafenib

Drug: PF-07799544

Phase 1b Substudy B Combination Dose Escalation

Experimental group

Description:

Participants will receive PF-07799544 and PF-07799933

Treatment:

Drug: PF-07799933

Drug: PF-07799544

Phase 1b Substudy B Combination Dose Expansion

Experimental group

Description:

Participants will receive PF-07799544 and PF-07799933

Treatment:

Drug: PF-07799933

Drug: PF-07799544

Phase 1b Substudy C Combination Dose Expansion

Experimental group

Description:

Participants will receive PF-07799544 and PF-07799933

Treatment:

Drug: PF-07799933

Drug: PF-07799544