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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06285097 | Registry Identifier | ClinicalTrials.gov |
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The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.
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This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy dose escalation (Part 1A) | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles |
|
| Combination dose escalation (Part 1B) | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency, in combination with sasanlimab (subcutaneous injection) at a fixed dose once every 4 weeks in 28-day cycles |
|
| Expansion (Part 2) - Tumor specific Arm A | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles |
|
| Expansion (Part 2) - Tumor specific Arm B | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles |
|
| Expansion (Part 2) - Arm C | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07820435 | Drug | immune agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B) | DLT rate estimated based on data from DLT-evaluable participants during the DLT evaluation period | Baseline through 28 days after first dose |
| Number of patients with adverse events (AEs) | Characterized by type, frequency, severity (CTCAE v5; CRS by ASTCT), timing, seriousness, and relationship to study drug(s) | Baseline through up to 2 years |
| Number of patients with clinically significant lab abnormalities | Characterized by type, frequency, severity (CTCAE v5), and timing | Baseline through up to 2 years |
| Objective response rate (ORR) in Part 2 Expansion | Tumor response as assessed using RECIST 1.1 | Baseline through 2 years or disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) in dose escalation (Part 1A and Part 1B) | Tumor response as assessed by RECIST 1.1 | Baseline through 2 years or disease progression |
| Duration of tumor response | Tumor response as assessed by RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists Sarasota Drug Development Unit | Sarasota | Florida | 34232 | United States | ||
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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 | A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2 |
|
| Baseline through 2 years or disease progression |
| Progression free survival (PFS) | Tumor response as assessed by RECIST 1.1 | Baseline through 2 years or disease progression |
| Cmax (maximum concentration) of PF-07820435 and its active metabolite | Single and multiple dose PK parameters of PF-07820435 and its active metabolite | Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3. |
| Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite | Single and multiple dose PK parameters of PF-07820435 and its active metabolite | Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3. |
| AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite | Single and multiple dose PK parameters of PF-07820435 and its active metabolite | Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3. |
| Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only | Multiple dose PK parameters of PF-07820435 and its active metabolite | Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3. |
| Change from baseline of immune markers within biopsied tumor tissue | Change in CD8 immune marker will be analyzed | Baseline through about 6 weeks after first dose |
| Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2) | Single and multiple dose PK parameters of sasanlimab | Day 1 (pre-dose) of each cycle (28 days) for the first 3 cycles, then Day 1 on every 3rd cycle until 2 years or disease progression |
| Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2) | Immunogenicity assessment | Day 1 (pre-dose) of each cycle (28 days) for the first 3 cycles, then Day 1 on every 3rd cycle until 2 years or disease progression |
| Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 | The analysis applies to Part 2 Food Effect Subset only | On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose. |
| Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 | The analysis applies to Part 2 Food Effect Subset only | On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose. |
| AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 | The analysis applies to Part 2 Food Effect Subset only | On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose. |
| Corewell Health (reference non-engagement letter) |
| Grand Rapids |
| Michigan |
| 49503 |
| 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 |
| Tristar Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| The Cancer Institute Hospital of JFCR | Koto | Tokyo | 135-8550 | Japan |
| Hospital Oncologico Dr. Isaac Gonzalez-Martinez | Rio Piedras | 00935 | Puerto Rico |
| Pan American Center for Oncology Trials, LLC | Rio Piedras | 00935 | Puerto Rico |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D006258 | Head and Neck Neoplasms |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital 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 |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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