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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06546553 | Registry Identifier | ClinicalTrials.gov |
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Study terminated as part of strategic considerations and not based on safety concerns.
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The purpose of this study is to learn about the:
This study is seeking participants who have solid tumors (An abnormal mass of tissue) that:
This includes (but limited to) the following cancer types:
All participants in this study will receive the study medication (PF-07826390) as an IV infusion (given directly into a vein) at the study once every four weeks in 28 day cycles.
The study participants depending on the group enrolled in, will receive the study medication (PF-07826390 alone or in combination with other anti-cancer medications (sasanlimab). Sasanlimab is given as a shot under the skin every 4 weeks.
Participants can continue to take the study medication (PF-07826390) until their cancer is no longer responding. Participants who are taking sasanlimab may receive it for up to 2 years.
The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.
Participants will be involved in this study for up to 4 years. During this time, participants will have a study visit every week. The participants after stopping the study medicine (at about 2 years) will be followed for another two years to see how the participants are doing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: PF-07826390 Monotherapy | Experimental | PF-07826390 monotherapy at prescribed dose and frequency in 28-day cycles |
|
| Part 1B: PF-07826390 + sasanlimab | Experimental | PF-07826390 + sasanlimab at prescribed dose and frequency in 28-day cycles |
|
| Part 2A (Arm 1): PF-07826390 + sasanlimab | Experimental | PF-07826390 + sasanlimab dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles |
|
| Part 2A (Arm 2): PF-07826390 + sasanlimab | Experimental | PF-07826390 + sasanlimab dose expansion in MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles |
|
| Part 2A (Arm 3): PF-07826390 + sasanlimab | Experimental | PF-07826390 + sasanlimab dose expansion in RCC 2L+ at prescribed dose and frequency in 28-day cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07826390 | Drug | PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors |
| Measure | Description | Time Frame |
|---|---|---|
| PART 1: Number of participants with Dose-limiting toxicities (DLT) | Any of the prespecified AEs that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes. | First cycle, Day 1 up to Day 28 |
| PART 1 & 2: Incidence of Adverse Events (AE)s | An adverse event (AE) is any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE is an AE 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. AEs included both serious and all non-serious AEs. | From start of the treatment and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first. |
| PART 1 & 2: Number of participants with laboratory abnormalities | Number of participants with laboratory test abnormalities. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). | From start of the treatment and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first. |
| Part 2: Objective Response - Number of Participants With Objective Response | Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator. | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response - Number of Participants with Objective Response | Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years |
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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 |
|---|---|---|---|---|---|---|
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States | ||
| Florida Cancer Specialists & Research Institute, LLC |
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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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| Part 2B: PF-07826390 | Experimental | PF-07826390 dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles |
|
| Part 2C: PF-07826390 + SOC | Experimental | PF-07826390 + SOC (anti-PD-1 + platinum -based chemo) dose expansion for a PDx-naive NSCLC 1L at prescribed dose and frequency in 28-day cycles |
|
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| sasanlimab | Biological | A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2 |
|
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| SOC (anti-PD-1 + platinum -based chemo) | Other | Standard of Care (anti-PD-1 + platinum -based chemo) |
|
| Time to event endpoints: duration of response (DOR) by RECIST v1.1 | Time to event: DOR according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by the Investigator. | Baseline to confirmed disease progression, up to 2 years after the last dose of study treatment |
| Time to event endpoints: progression-free survival (PFS) by RECIST v1.1 | Time to event: PFS according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by the Investigator. | Baseline to confirmed disease progression, up to 2 years after the last dose of study treatment |
| Part 1: Maximum Observed Serum Concentration (Cmax) | Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only. | Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days) |
| Part 1: Time to Reach Maximum Serum Concentration (Tmax) of PF-07826390 | Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only. | Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days) |
| Part 1: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07826390 | Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only. | Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days) |
| Part 1: Serum Area Under the Curve From Time Zero to Last Time Zero to clearance (CL/F) of PF-07826390 | Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only. | Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days) |
| Part 1: Serum under the curve apparent volume of distribution during terminal phase (Vz/F) of PF-07826390 | Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only. | Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days) |
| Part 1: Serum under the curve terminal elimination half life (T ½) of PF-07826390 | Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only. | Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days) |
| Part 1 and Part 2: Serum Concentrations of PF-07826390 in combination (Part 1B, 2A and 2C) | Day 1 (all cycles) and EOT. | Prior to dosing at Cycle 1+ Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 1 and Part 2: Incidence and titers of antidrug antibodies (ADA) against PF-07826390 | Day 1 (all cycles) and end of treatment | Prior to dosing at Cycle 1+ Day 1 up to end of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 1 and Part 2: Paried Tumor Biopsies | Pre-dose and C2 Day 15 | Baseline through Cycle 2 Day 15 (each cycle is 28 days) |
| Part 2: Time to Reach Maximum Serum Concentration (Tmax) of PF-07826390 | Cycle 1, 2 and 3: Pre-dose, 1, 24, and 336 hours post dose. Cycle 4 and beyond Pre-dose only. | Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 2: Maximum Observed Serum Concentration (Cmax) of PF-07826390 | Cycle 1, 2 and 3: Pre-dose, 1, 24, and 336 hours post dose. Cycle 4 and beyond Pre-dose only. | Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 1: Pharmacodynamic blood samples: Receptor occupancy | Cycle 1: Pre-dose, 48, 168 and 336 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3 and beyond pre-dose only. | Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 2: Pharmacodynamic blood samples Receptor Occupancy | Cycle 1: Pre-dose, 24 and 336 hours post dose, Cycle 2: Pre-dose, 24 and 336 hours post dose. Cycle 3 and beyond pre-dose only. | Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 2: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07826390 | Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose. | Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 2: Serum Area Under the Curve From Time Zero to clearance (CL/F) of PF-07826390 | Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose. | Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 2: Serum under the curve apparent volume of distribution during terminal phase (Vz/F) of PF-07826390 | Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose. | Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Part 2: Serum under the curve terminal elimination half life (T ½) of PF-07826390 | Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose. | Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days) |
| Fort Myers |
| Florida |
| 33916 |
| United States |
| Florida Cancer Specialists | Orlando | Florida | 32827 | United States |
| Sarah Cannon Research Institute at Florida Cancer Specialists | Orlando | Florida | 32827 | United States |
| START Midwest | Grand Rapids | Michigan | 49546 | United States |
| START San Antonio | San Antonio | Texas | 78229 | United States |
| START Mountain Region | West Valley City | Utah | 84119 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002292 | Carcinoma, Renal Cell |
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D009362 | Neoplasm Metastasis |
| D007680 | Kidney Neoplasms |
| D012002 | Rectal Diseases |
| D008545 | Melanoma |
| 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 |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D000230 | Adenocarcinoma |
| 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 |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
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| ID | Term |
|---|---|
| D000075362 | Leukocyte Immunoglobulin-like Receptor B1 |
| ID | Term |
|---|---|
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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