Clinical trial NCT06580938: A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer
Official title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF PF-07921585 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH ADVANCED SOLID TUMORS
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Bladder Cancer
Renal Cell Carcinoma
Melanoma
Head and Neck Cancer
Colorectal Cancer
Keywords: Interleukin-12 mutein
Sasanlimab
anti-PD1 antibody
lung cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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
* melanoma (a type of skin cancer)
* kidney cancer
* head and neck cancer Participants will receive the study medicine PF-07921585 alone or in combination with another study medicine called sasanlimab at the study clinic.

PF-07921585 will be given as an infusion into a vein or as shots under the skin, once every 3 weeks. Sasanlimab will be given as shots under the skin, also once every 3 weeks.

The experiences of participants receiving the study medicine will be studied to help see if the study medicine is safe and effective. Participants may receive study medicine for up to 2 years, depending on how the cancer responds to the study treatment. Participants may continue receiving study medicine after 2 years if there are any benefits from the study treatment. Participants will attend visits once every 3 weeks with the first 9 weeks having more frequent visits, to check the safety of the study treatment.

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.

Part 2: dose escalation of PF-07921585 in combination with the anti-PD 1 inhibitor sasanlimab and potentially other anti-cancer agents, in order to determine the recommended dose for expansion of the combination.

Part 3: dose optimization/ expansion will evaluate PF-07921585 in combination with sasanlimab, and potentially other anti-cancer agents. After identification of the recommended dose for expansion in Part 2, participants with select solid tumors will be enrolled into 3-4 cohorts as follows:

* Cohort 1: Melanoma
* Cohort 2: Microsatellite stable (MSS) metastatic colorectal cancer
* Cohort 3: Non-small cell lung cancer (NSCLC)
* Cohort 4: Solid tumor, tumor types and clinical setting to be determined based on emerging data.

Eligibility criteria: Key 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 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

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2)
timeFrame: Baseline up to Cycle 2 (each cycle is 21 days)
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2)
timeFrame: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2)
timeFrame: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab
measure: Objective Response Rate - Percentage of Participants With Objective Response (Part 3)
timeFrame: Date of first dose up to 2 years
Secondary outcomes:
measure: Number of Participants with Treatment emergent Adverse Events (AEs) and Serious AEs (Part 3)
timeFrame: Baseline up to 28 days after the last dose of PF-07921585 and 90 days after the last dose of sasanlimab
measure: Objective Response Rate-Percentage of Participants with objective response (Parts 1 and 2)
timeFrame: Date of first dose up to 2 years
measure: Duration of response (DOR)-Parts 1-3
timeFrame: Date of first dose up to 2 years
measure: Disease control rate (DCR)-Parts 1-3
timeFrame: Date of first dose up to 2 years
measure: Progression Free survival (PFS)-Parts 1-3
timeFrame: Date of first dose until disease progression or death, up to a maximum of 4 years
measure: Overall Survival (OS)-Part 3
timeFrame: Date of first dose until death, up to a maximum of 4 years
measure: Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)-PF-07921585
timeFrame: At specific timepoints from Cycle 1 day 1 up to 2 years
measure: Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax ss)-PF-07921585
timeFrame: At specific timepoints from Cycle 1 day 1 up to 2 years
measure: Pharmacokinetic Parameters: Area under the curve (AUCt)-PF-07921585
timeFrame: At specific timepoints from Cycle 1 day 1 up to 2 years
measure: Pharmacokinetic Parameters: Area under the curve (AUCt ss)-PF-07921585
timeFrame: At specific timepoints from Cycle 1 day 1 up to 2 years
measure: Pharmacokinetic Parameters: Cmax (maximum drug concentration in the body)-PF-07921585
timeFrame: At specific timepoints from Cycle 1 day 1 up to 2 years
measure: Pharmacokinetic Parameters: Cmax ss (maximum drug concentration in the body)-PF-07921585
timeFrame: At specific timepoints from Cycle 1 day 1 up to 2 years
measure: Percentage of Participants With Positive PF-07921585 Anti-Drug Antibody (ADA)
timeFrame: At specific timepoints from Cycle 1 day 1 up to 2 years
measure: Percentage of Participants With Positive PF-07921585 neutralizing antibodies (Nab)
timeFrame: At specific timepoints from Cycle 1 Day 1 up to 2 years
measure: Incidence and titer of PF-07921585 ADA and Nab
timeFrame: At specific timepoints from Cycle 1 Day 1 up to 2 years
measure: Pharmacokinetic Parameters: C through-Sasanlimab
timeFrame: At specific timepoints, predose, from Cycle 1 day 1 up to 2 years
measure: Percentage of Participants With Positive sasanlimab Anti-Drug Antibody (ADA)
timeFrame: At specific timepoints from Cycle 1 day 1 up to 2 years
measure: Percentage of Participants With Positive sasanlimab neutralizing antibodies (Nab)
timeFrame: At specific timepoints from Cycle 1 Day 1 up to 2 years
measure: Incidence and titer of sasanlimab ADA and Nab
timeFrame: At specific timepoints from Cycle 1 Day 1 up to 2 years
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Denver
country: United States
facility: Presbyterian/St. Lukes Medical Center
state: Colorado
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: Sarasota
country: United States
facility: Florida Cancer Specialists Sarasota Drug Development Unit
state: Florida
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: