Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04628780 |
Recruitment Status :
Active, not recruiting
First Posted : November 16, 2020
Last Update Posted : October 12, 2022
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This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy.
The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small-cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Renal Cell Carcinoma Urothelial Carcinoma Colorectal Carcinoma Ovarian Carcinoma | Biological: PF-07209960 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS |
Actual Study Start Date : | December 16, 2020 |
Estimated Primary Completion Date : | February 25, 2024 |
Estimated Study Completion Date : | February 25, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation (Part 1)
Participants will receive PF-07209960 at escalating dose levels
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Biological: PF-07209960
PD-1 targeted IL-15 mutein |
Experimental: Dose Expansion (Part 2) - Cohort 1 (NSCLC)
Participants with non-small cell lung cancer (NSCLC) will receive PF-07209960 at the recommended dose from Part 1
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Biological: PF-07209960
PD-1 targeted IL-15 mutein |
Experimental: Dose Expansion (Part 2) - Cohort 2 (RCC)
Participants with renal cell carcinoma (RCC) will receive PF-07209960 at the recommended dose from Part 1
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Biological: PF-07209960
PD-1 targeted IL-15 mutein |
Experimental: Dose Expansion (Part 2) - Cohort 3 (UC)
Participants with urothelial carcinoma (UC) will receive PF-07209960 at the recommended dose from Part 1
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Biological: PF-07209960
PD-1 targeted IL-15 mutein |
- Number of participants with dose limiting toxicities (DLTs) in Dose Escalation (Part 1) [ Time Frame: Baseline through 28 days after first dose (Cycle 1) ]DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose
- Number of participants with adverse events (AEs) [ Time Frame: Baseline through up to 2 years ]AEs as characterized by type, frequency, severity (graded by CTCAE v.5.0; CRS graded by ASTCT criteria), timing, seriousness, and relationship to study drug
- Number of participants with clinically significant laboratory abnormalities [ Time Frame: Baseline through up to 2 years ]Laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE v.5.0), and timing
- Objective response rate (ORR) in the Expansion cohorts (Part 2) [ Time Frame: Baseline through up to 2 years or until disease progression ]Tumor response based on RECIST 1.1
- ORR in Dose Escalation (Part 1) [ Time Frame: Baseline through up to 2 years or until disease progression ]Tumor response based on RECIST 1.1
- Single dose: Maximal concentration (Cmax) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]PK assessment for PF-07209960
- Single dose: Time to maximal plasma concentration (Tmax) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]PK assessment for PF-07209960
- Single dose: Area Under the Curve within one dosing interval (AUCtau) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]PK assessment for PF-07209960
- Multiple dose: Maximum observed steady state plasma concentration (Cmax,ss) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]PK assessment for PF-07209960
- Multiple dose: Time to reach Maximum Observed Steady State Plasma Concentration (Tmax,ss) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]PK assessment for PF-07209960
- Multiple dose: Area Under the curve within one dose interval at steady state (AUCtau,ss) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]PK assessment for PF-07209960
- Lowest concentration (Ctrough) reached before the next dose is administered [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]PK assessment for PF-07209960
- Immunogenicity in Expansion Cohorts (Part 2) [ Time Frame: Cycle 1 (each cycle is 28 days), Cycle 2, and Day 1 of each subsequent cycle, and at the End of Treatment visit, up to about 2 years ]Incidence, titers, and endogenous IL-15 cross-reactivity of anti-drug antibody and neutralizing antibody against PF-07209960
- Intratumor T cells in pre-treatment vs. on-treatment tumor biopsy samples in Expansion Cohorts (Part 2) [ Time Frame: Baseline through start of Cycle 2 ]Effect of PF-07209960 therapy on immune cells in tumor biopsies
- Disease control rate (DCR) [ Time Frame: Baseline through up to 2 years or until disease progression ]DCR as assessed using RECIST 1.1
- Duration of response (DOR) [ Time Frame: Baseline through up to 2 years or until disease progression ]DOR as assessed using RECIST 1.1
- Time to progression (TTP) [ Time Frame: Baseline through up to 2 years or until disease progression ]TTP as assessed using RECIST 1.1
- Progression free survival (PFS) [ Time Frame: Baseline through up to 2 years or until disease progression ]PFS as assessed using RECIST 1.1
- Overall survival (OS) in the Expansion Cohorts (Part 2) [ Time Frame: Baseline through up to 2 years ]Proportion of participants alive

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological/cytological diagnosis of selected locally advanced or metastatic solid tumor
- Demonstrated radiographic progression on most recent tumor assessment imaging
- Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated
- Eastern Cooperative Oncology Group performance status 0-2 for Part 1 and 0-1 for Part 2
- Adequate hematologic, renal, liver, and coagulation functions
- LVEF ≥50% by echocardiogram or MUGA
- Resolved acute effects of any prior therapy
- Participants in Dose Expansion (Part 2) must have ≥2 prior lines of standard of care therapy
- Able to provide tumor tissue for submission to the Sponsor, including mandatory pre-treatment tumor biopsy (adequate archival tissue within the past 1 year is accepted in lieu of new biopsy) for all participants. Participants in Part 2 must also be able to undergo new (de novo) tumor biopsy at baseline (pre-treatment) and on-treatment biopsy until the Sponsor deems that an adequate number of biopsied samples have been received.
Exclusion Criteria:
- Known active symptomatic brain or leptomeningeal metastases requiring steroids.
- Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation therapy within 4 weeks prior to planned first dose
- Last systemic anti-cancer therapy within 4 weeks prior to planned first dose (6 weeks for mitomycin C or nitrosoureas). Participants who received anti-PD-1 therapy require an interval of 90 days prior to first dose
- Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose
- Active and clinically significant bacterial, fungal, or viral infection; Hepatitis B or Hepatitis C infection, AIDS-related illness (HIV+ and in good immune health as defined in the protocol may be eligible)
- Active COVID-19/SARS-CoV2
- Anticoagulation with vitamin K antagonists is not allowed
- Active bleeding disorder in the past 6 months prior to first dose
- History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy)
- History of interstitial lung disease or pneumonitis
- Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant
- Pregnant or breastfeeding female participant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628780
United States, California | |
City of Hope Investigational Drug Service (IDS) | |
Duarte, California, United States, 91010 | |
City of Hope | |
Duarte, California, United States, 91010 | |
Ronald Reagan UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
UCLA Hematology/Oncology | |
Los Angeles, California, United States, 90095 | |
Santa Monica UCLA Medical Center & Orthopaedic Hospital | |
Santa Monica, California, United States, 90404 | |
UCLA Hematology Oncology - Santa Monica | |
Santa Monica, California, United States, 90404 | |
United States, Tennessee | |
The Sarah Cannon Research Institute/Tennessee Oncology | |
Nashville, Tennessee, United States, 37203 | |
TriStar Centennial Medical Center | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center- Investigational Pharmacy | |
Houston, Texas, United States, 77030 | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Christus Santa Rosa Hospital | |
San Antonio, Texas, United States, 78229 | |
NEXT Oncology | |
San Antonio, Texas, United States, 78229 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT04628780 |
Other Study ID Numbers: |
C4011001 2021-004587-10 ( EudraCT Number ) |
First Posted: | November 16, 2020 Key Record Dates |
Last Update Posted: | October 12, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
PD-1 immune checkpoint inhibitor IL-15 IL-2 cytokine |
immunotherapy Metastasis advanced solid tumor metastatic solid tumor |
Carcinoma Carcinoma, Renal Cell Squamous Cell Carcinoma of Head and Neck Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Carcinoma, Squamous Cell Adenocarcinoma Kidney Neoplasms Urologic Neoplasms |
Urogenital Neoplasms Kidney Diseases Urologic Diseases Head and Neck Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |