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

Conditions

• Advanced or Metastatic Solid Tumors
• Brain Neoplasms
• Differentiated Thyroid Cancer
• Glioma
• HGG
• High Grade Glioma
• LGG
• Low Grade Glioma
• Malignant Neoplasms
• Melanoma
• NSCLC (Non-small Cell Lung Cancer)
• Non-Small Cell Lung Cancer
• Thyroid Cancer

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-07799544 — DRUG
  Tablet
• PF-07799933 — DRUG
  Tablet

Study Details

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.

Key Dates

Start date

Nov 30, 2022

Status verified

Jun 2026

Primary completion

Aug 2, 2027

Completion

Jun 18, 2029

Study Design

Enrollment

124 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Cycle 1 (21 days) ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (58)

Find similar trials in Birmingham, AL

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