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

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-07799544: Tablet

PF-07799933: Tablet

Study summary

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.

Eligibility

Primary outcome measure(s)

• Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs) — Cycle 1 (21 days)
  DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
• Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs) — Baseline to 28 days after last dose of study medication
  AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
• Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities — Baseline to 28 days after last dose of study treatment
  Laboratory abnormalities as characterized by type, frequency, severity, and timing.
• Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities — Baseline to 28 days after last dose of study treatment
  Vital sign abnormalities as characterized by type, frequency, severity, and timing.
• Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities — Baseline to 28 days after last dose of study treatment
  Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
• Phase 1b Dose Expansion: Overall response rate (ORR) — Baseline to 2 years
  Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors

Trial sites (66)

+ 26 more sites — see the full list on the official registry below.

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