Study of PF-07265807 in Participants With Metastatic Solid Tumours.

Official Title

A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

Summary:

A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumours

Trial Description

Primary Outcome:

  • Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
  • Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
  • Parts 1, 2, and 3: Number of participants with laboratory abnormalities
  • Part 4: Overall Response Rate (ORR)
  • Part 4, Cohort 4: Complete Response (CR)
Secondary Outcome:
  • Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
  • Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
  • Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
  • Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
  • Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
  • Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
  • Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite
  • Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
  • Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite
  • Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
  • Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
  • Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
  • Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
  • Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
  • Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
  • Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
  • Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
  • Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
  • Parts 1, 2, and 3: ORR
  • Part 4: Number of participants with treatment emergent AEs
  • Part 4: Number of participants with laboratory abnormalities
  • Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
  • Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
  • Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
  • Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
  • Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination
  • Duration of Response
  • Disease Control Rate
  • Progression Free Survival

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society