An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-07994525: Oral administration

Midazolam: Oral administration

Study summary

This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R/R MM.

The study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R/R MM. In Part 2 (Dose expansion), PF-07994525 may be evaluated in additional participants with R/R MM to further assess safety, PK, PD, and preliminary anti-tumor activity.

Eligibility

Primary outcome measure(s)

• Type, incidence and severity of participants with adverse events (AEs) — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
  Type, incidence, severity (graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0), timing, seriousness, and relatedness of adverse events (AEs)
• Type, incidence and severity of participants with laboratory abnormalities — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
  Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
• Number of participants with dose modifications — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
  Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions, and treatment discontinuations) due to AEs
• Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) — Baseline to end of DLT evaluation period
  Occurrence of DLTs as defined by the protocol
• Part 1: Recommended Monotherapy Dose for Expansion (RDE) — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
  RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings
• Part 2: Recommended Dose for future development — From the first day through 30-37 days after the last study treatment, up to approximately 2 years
  Safety, and preliminary anti-tumor activity

Trial sites (19)