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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06580938 | Registry Identifier | ClinicalTrials.gov |
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The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns
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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:
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Dose escalation monotherapy |
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| Part 2 | Experimental | Dose escalation (combination therapy) |
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| Part 3 | Experimental | Dose optimization/ expansion (combination therapy) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07921585 | Biological | IL-12 mutein, solution, administered once every 3 weeks intravenously or subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2) | Specific adverse events occurring during the first 21 days of study medication and considered at least possibly-related to study medication | Baseline up to Cycle 2 (each cycle is 21 days) |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2) | 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/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 or 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2) | Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. | Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab |
| Objective Response Rate - Percentage of Participants With Objective Response (Part 3) | 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). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment emergent Adverse Events (AEs) and Serious AEs (Part 3) | 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/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 or 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
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Key Inclusion Criteria:
Participants aged ≥18 years or older at the time of informed consent.
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:
ECOG PS 0 or 1.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Highlands Oncology Group |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| Sasanlimab | Biological | Anti-PD1 antibody solution, administered once every 3 weeks subcutaneously |
|
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| Date of first dose up to 2 years |
| Baseline up to 28 days after the last dose of PF-07921585 and 90 days after the last dose of sasanlimab |
| Objective Response Rate-Percentage of Participants with objective response (Parts 1 and 2) | 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). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | Date of first dose up to 2 years |
| Duration of response (DOR)-Parts 1-3 | 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. | Date of first dose up to 2 years |
| Disease control rate (DCR)-Parts 1-3 | 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. | Date of first dose up to 2 years |
| Progression Free survival (PFS)-Parts 1-3 | 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. | Date of first dose until disease progression or death, up to a maximum of 4 years |
| Overall Survival (OS)-Part 3 | Time in weeks or months from the start of study treatment to date of death due to any cause. | Date of first dose until death, up to a maximum of 4 years |
| Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)-PF-07921585 | 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 | At specific timepoints from Cycle 1 day 1 up to 2 years |
| Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax ss)-PF-07921585 | 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 | At specific timepoints from Cycle 1 day 1 up to 2 years |
| Pharmacokinetic Parameters: Area under the curve (AUCt)-PF-07921585 | 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 | At specific timepoints from Cycle 1 day 1 up to 2 years |
| Pharmacokinetic Parameters: Area under the curve (AUCt ss)-PF-07921585 | 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 | At specific timepoints from Cycle 1 day 1 up to 2 years |
| Pharmacokinetic Parameters: Cmax (maximum drug concentration in the body)-PF-07921585 | Single dose PK of PF-07921585 as monotherapy will be calculated. Additional parameters may be calculated if data permits | At specific timepoints from Cycle 1 day 1 up to 2 years |
| Pharmacokinetic Parameters: Cmax ss (maximum drug concentration in the body)-PF-07921585 | 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 | At specific timepoints from Cycle 1 day 1 up to 2 years |
| Percentage of Participants With Positive PF-07921585 Anti-Drug Antibody (ADA) | Percentage of ADA positive participants by dose level (Parts 1-3) | At specific timepoints from Cycle 1 day 1 up to 2 years |
| Percentage of Participants With Positive PF-07921585 neutralizing antibodies (Nab) | Percentage of Nab positive participants by dose level (Parts 1-3) | At specific timepoints from Cycle 1 Day 1 up to 2 years |
| Incidence and titer of PF-07921585 ADA and Nab | Parts 1-3 | At specific timepoints from Cycle 1 Day 1 up to 2 years |
| Pharmacokinetic Parameters: C through-Sasanlimab | PK of sasanlimab (Parts 2 and 3) | At specific timepoints, predose, from Cycle 1 day 1 up to 2 years |
| Percentage of Participants With Positive sasanlimab Anti-Drug Antibody (ADA) | Percentage of ADA positive participants by dose level (Parts 2-3) | At specific timepoints from Cycle 1 day 1 up to 2 years |
| Percentage of Participants With Positive sasanlimab neutralizing antibodies (Nab) | Percentage of Nab positive participants by dose level (Parts 2-3) | At specific timepoints from Cycle 1 Day 1 up to 2 years |
| Incidence and titer of sasanlimab ADA and Nab | Parts 2-3 | At specific timepoints from Cycle 1 Day 1 up to 2 years |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States |
| Presbyterian/St. Lukes Medical Center | Denver | Colorado | 80218 | United States |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | United States |
| Florida Cancer Specialists Sarasota Drug Development Unit | Sarasota | Florida | 34232 | United States |
| START Midwest | Grand Rapids | Michigan | 49546 | United States |
| Sarah Cannon Research Institute- Pharmacy | Nashville | Tennessee | 37203 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001749 | Urinary Bladder Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D008545 | Melanoma |
| D006258 | Head and Neck Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D007674 | Kidney Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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