A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer

Registration Number
NCT06580938
Lead Sponsor
Pfizer
Brief Summary

The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07921585) in people with cancer that has advanced or spread to other parts of the body.

This study is seeking participants who have any of the following cancer types:

* non-small cell lung cancer

* colorectal cancer

* bladder cancer
...

Detailed Description

The study contains 3 parts:

Part 1: dose escalation of PF-07921585 as single agent to determine the monotherapy recommended dose for further study.
...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
190
Inclusion Criteria
  1. Participants aged ≥18 years or older at the time of informed consent.

  2. Tumor types and prior treatment requirements: Participants entering Parts 2 and 3 must have at least 1 measurable lesion.

    Part 1 and Part 2:

    Eligible advanced/metastatic tumor types include NSCLC, urothelial carcinoma (UC), renal cell carcinoma (RCC), melanoma, head and neck squamous cell carcinoma (HNSCC), and microsatellite stable colorectal cancer (MSS-CRC). Participants must have demonstrated radiographic progression on standard treatment(s) for their cancer

    Part 3:

    • Cohort 1: Participants with metastatic melanoma with resistance to checkpoint inhibitor therapy and BRAF/MEKi.
    • Cohort 2: Participants with metastatic MSS-CRC.
    • Cohort 3: Participants with previously untreated metastatic NSCLC.
  3. ECOG PS 0 or 1.

Key

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Exclusion Criteria
  1. Participants with any other active malignancy within 3 years prior to enrollment.
  2. Known or suspected hypersensitivity to, or severe allergic history of, human albumin or anti-PD-(L)1 therapy.
  3. History of Grade ≥3 immune-related AE (irAE) or unresolved irAEs prior to first dose of study intervention. Exception: vitiligo and endocrinopathy that is controlled with hormonal therapy.
  4. History of venous thromboembolic event <12 weeks prior to starting study treatment.
  5. Active or history of clinically significant gastrointestinal (GI) disease.
  6. Active or history of interstitial lung disease or Grade ≥2 pneumonitis.
  7. Active or history of clinically significant autoimmune disease.
  8. Active bleeding disorder.
  9. Participants who have undergone treatment with any investigational IL-12 agent.
  10. Active, uncontrolled infections
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Part 1PF-07921585Dose escalation monotherapy
Part 2PF-07921585Dose escalation (combination therapy)
Part 2SasanlimabDose escalation (combination therapy)
Part 3PF-07921585Dose optimization/ expansion (combination therapy)
Part 3SasanlimabDose optimization/ expansion (combination therapy)
Primary Outcome Measures
NameTimeMethod
Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2)Baseline up to Cycle 2 (each cycle is 21 days)

Specific adverse events occurring during the first 21 days of study medication and considered at least possibly-related to study medication

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2)Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

AEs are any untoward medical occurrence in a participant who received study drug. Serious adverse event (SAE) are AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapaci...

Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2)Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

Objective Response Rate - Percentage of Participants With Objective Response (Part 3)Date of first dose up to 2 years

Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1. 1 (RECIST 1.1).
...

Secondary Outcome Measures
NameTimeMethod
Pharmacokinetic Parameters: Area under the curve (AUCt ss)-PF-07921585At specific timepoints from Cycle 1 day 1 up to 2 years

Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits

Pharmacokinetic Parameters: Cmax (maximum drug concentration in the body)-PF-07921585At specific timepoints from Cycle 1 day 1 up to 2 years

Single dose PK of PF-07921585 as monotherapy will be calculated. Additional parameters may be calculated if data permits

Percentage of Participants With Positive PF-07921585 Anti-Drug Antibody (ADA)At specific timepoints from Cycle 1 day 1 up to 2 years

Percentage of ADA positive participants by dose level (Parts 1-3)

Pharmacokinetic Parameters: Cmax ss (maximum drug concentration in the body)-PF-07921585At specific timepoints from Cycle 1 day 1 up to 2 years

Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits

Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax ss)-PF-07921585At specific timepoints from Cycle 1 day 1 up to 2 years

Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits

Pharmacokinetic Parameters: Area under the curve (AUCt)-PF-07921585At specific timepoints from Cycle 1 day 1 up to 2 years

Single dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits

Number of Participants with Treatment emergent Adverse Events (AEs) and Serious AEs (Part 3)Baseline up to 28 days after the last dose of PF-07921585 and 90 days after the last dose of sasanlimab

AEs are any untoward medical occurrence in a participant who received study drug. Serious adverse event (SAE) are AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapaci...

Objective Response Rate-Percentage of Participants with objective response (Parts 1 and 2)Date of first dose up to 2 years

Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1. 1 (RECIST 1.1).
...

Duration of response (DOR)-Parts 1-3Date of first dose up to 2 years

Time in weeks or months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause.

Disease control rate (DCR)-Parts 1-3Date of first dose up to 2 years

DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1, at 6 weeks.

Progression Free survival (PFS)-Parts 1-3Date of first dose until disease progression or death, up to a maximum of 4 years

Time in weeks or months from first dose to first documentation of objective tumor progression per RECIST 1.1 or death due to any cause.

Overall Survival (OS)-Part 3Date of first dose until death, up to a maximum of 4 years

Time in weeks or months from the start of study treatment to date of death due to any cause.

Percentage of Participants With Positive PF-07921585 neutralizing antibodies (Nab)At specific timepoints from Cycle 1 Day 1 up to 2 years

Percentage of Nab positive participants by dose level (Parts 1-3)

Incidence and titer of PF-07921585 ADA and NabAt specific timepoints from Cycle 1 Day 1 up to 2 years

Parts 1-3

Pharmacokinetic Parameters: C through-SasanlimabAt specific timepoints, predose, from Cycle 1 day 1 up to 2 years

PK of sasanlimab (Parts 2 and 3)

Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)-PF-07921585At specific timepoints from Cycle 1 day 1 up to 2 years

Single dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sansalimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits

Percentage of Participants With Positive sasanlimab Anti-Drug Antibody (ADA)At specific timepoints from Cycle 1 day 1 up to 2 years

Percentage of ADA positive participants by dose level (Parts 2-3)

Percentage of Participants With Positive sasanlimab neutralizing antibodies (Nab)At specific timepoints from Cycle 1 Day 1 up to 2 years

Percentage of Nab positive participants by dose level (Parts 2-3)

Incidence and titer of sasanlimab ADA and NabAt specific timepoints from Cycle 1 Day 1 up to 2 years

Parts 2-3

Trial Locations

Locations (2)

START Midwest

🇺🇸

Grand Rapids, Michigan, United States

Highlands Oncology Group

🇺🇸

Springdale, Arkansas, United States

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