A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-08032562: Taken by mouth (PO)

Fulvestrant: Selective Estrogen Receptor Degrader (SERD)

Cetuximab: Monoclonal antibody (EGFR inhibitor)

Fluorouracil: Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

Oxaliplatin: Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)

Leucovorin: Part of FOLFOX chemotherapy regimen (folic acid analog)

Bevacizumab: Monoclonal antibody (VEG-F inhibitor)

Study summary

The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.

This study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC).

All participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles.

Depending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.

Eligibility

Primary outcome measure(s)

• Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) — Baseline up to 28 days
  Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.
• Part 1 (Dose Escalation): Number of participants with laboratory abnormalities — From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
  Number of participants with laboratory test abnormalities.
• Part 1 (Dose Escalation): Incidence of Adverse Events (AEs) — From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
  An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
• Part 2 (Dose Expansion): Objective Response Rate (ORR) — Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)
  ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Trial sites (13)

On this site

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