A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-08046876: Intravenous administration

Pembrolizumab: Intravenous administration

Cisplatin: Intravenous administration

Carboplatin: Intravenous administration

Study summary

The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.

The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.

Eligibility

Primary outcome measure(s)

• Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation — Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
  AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.
• Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy — Baseline to end of DLT evaluation period
  Occurrence of DLTs as defined by the protocol
• Part 1: Recommended Monotherapy Dose for Expansion — Baseline to 30 days post last study drug administration
  RDE will be based on cumulative safety, preliminary anti-tumor activity and pharmacokinetics findings
• Part 2: Recommended Monotherapy Phase 2 Dose — Baseline to 30 days post last study drug administration
  RP2D will be determined based on the cumulative safety, preliminary anti-tumor activity, and pharmacokinetics findings.
• Part 3: Recommended Combination Phase 2 Dose/ Recommended Combination Dose for Expansion — Baseline to 30 days post last study drug administration
  RP2D/RDE will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.

Trial sites (31)

On this site

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