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Strategic business decision
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The purpose of this study is to learn about the safety (the impact of the study drug on the participant's body), effects of the study drug alone or in combination with bevacizumab or sasanlimab, and to find the best dose.
This study is seeking participants who have solid tumors that:
This includes (but limited to) the following cancer types:
All participants in this study will receive the study medication (PF-07329640) as an IV infusion (given directly into a vein) at the study clinic every week for repeating 28-day cycles.
Depending on which part of the study participants are enrolled in they will receive the study medication (PF-07329640 alone or in combination with other anti-cancer medications (bevacizumab or sasanlimab). Bevacizumab is given in the clinic as IV infusion every two weeks and sasanlimab is given as a shot under the skin every 4 weeks.
Participants can continue to take the study medication (PF-07329640) and bevacizumab 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, they will have a study visit every week. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: PF-07329640 (αLTβR) Monotherapy | Experimental | PF-07329640 (αLTβR) monotherapy at prescribed dose and frequency in 28-day cycles |
|
| Part 1B: PF-07329640 (αLTβR) + bevacizumab | Experimental | PF-07329640 (αLTβR) + bevacizumab dose escalation in NSCLC and MSS CRC at prescribed dose and frequency in 28-day cycles |
|
| Part 1C: PF-07329640 (αLTβR) + sasanlimab | Experimental | PF-07329640 (αLTβR) + sasanlimab dose escalation in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles |
|
| Part 2A: PF-07329640 (αLTβR) + bevacizumab | Experimental | PF-07329640 (αLTβR) + bevacizumab dose expansion in NSCLC 2L+ and MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles |
|
| Part 2B: PF-07329640 (αLTβR) + sasanlimab | Experimental | PF-07329640 (αLTβR) + sasanlimab dose expansion in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07329640 | Biological | an anti-lymphotoxin beta receptor agonist |
|
| 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) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was 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 up to 90 days after last dose or start of new anticancer therapy, whichever occurred first |
| To: 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 treatment 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 best overall response (BOR) 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 |
|---|---|---|
| Part 1: 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:
Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
Part 1:
Part 2:
Part 2A:
Cohort 1: Participants with NSCLC must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies.
Cohort 2: Participants with MSS CRC must have received at least fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF agent (if not receiving anti-VEGF on protocol), and anti-epidermal growth factor receptor (EGFR) inhibitor (if RAS wildtype) and/or other molecularly targeted therapy if appropriate.
Part 2B:
Part 2C; anti-PDx naive NSCLC (1L) participants must not have received standard of care therapy with anti-PD-(L)1.
At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
Able to provide pre-treatment (and optional on-treatment) tumor tissue
Resolution of acute effects of any prior therapy to either baseline or CTCAE Grade 1
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 | Fayetteville | Arkansas | 72703 | United States | ||
| Highlands Oncology |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 16, 2025 | |
| Reset | Aug 5, 2025 | |
| Release | Apr 30, 2026 |
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|
| Part 2C: PF-07329640 (αLTβR) + SOC | Experimental | PF-07329640 (αLTβR) + SOC (anti-PD-1+ platinum-based chemo) dose expansion for αPDx-naïve NSCLC 1L at prescribed dose and frequency in 28-day cycles |
|
| Part 2D: PF-07329640 (αLTβR) | Experimental | PF-07329640 (αLTβR) dose expansion in advanced solid tumors at prescribed dose and frequency in 28-day cycles |
|
|
| sasanlimab | Biological | A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2 |
|
|
| bevacizumab | Biological | a monoclonal antibody that blocks VEGF |
|
|
| 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 treatmennt |
| 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 treatmennt |
| Part 1A: Maximum Observed Serum Concentration (Cmax) of PF-07329640 | Cycle 1: Pre-dose, End of Infusion (EOI), 4, and 8 hours Cycle 2: Pre-dose, EOI, 4, and 8 hours | Cycle 1 Day 1 & Cycle 2 Day 1 (each cycle is 28 days) |
| Part 1A: Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-07329640 | Cycle 1: Pre-dose, End of Infusion (EOI), 4, and 8 hours Cycle 2: Pre-dose, EOI, 4, and 8 hours | Cycle 1 Day 1 & Cycle 2 Day 1 (each cycle is 28 days) |
| Part 1A: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07329640 | Cycle 1: Pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 72 hours post-dose (Day 1-4); Pre-dose, EOI, 4 hours post-dose (Day 8); pre-dose, EOI (Day 15) Cycle 2: Pre-dose, EOI, 4, 8, 24, 48, 72 hours post-dose (Day 1-4); Pre-dose, and 4 hours post-dose (Day 15) | Cycle 1 Day 1 & Cycle 2 Day 1 (each cycle is 28 days) |
| Serum Concentrations of PF-07329640 in combination (Part 1B/1C/2A/2B/2C) | comparison Predose and end of infusion blood serum concentrations at Cycle 1 day 1 and 15, and Cycle Day 1 | pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1Day 15, Cycle 2 Day 1 (Each cycle is 28 days) |
| Incidence and titers of antidrug antibodies (ADA) against PF-07329640 | the number of patients with ADAs against PF-07329640 and the concentration of those ADAs | Baseline though study completion, an average of 2 years |
| Paired Tumor Biopsies | Changes in quantity and maturation state of tertiary lymphoid structure (TLS)s in tumor biopsy tissues at Cycle 2 Day 15 | Baseline through Cycle 2 Day 15 (each cycle is 28 days) |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| Hospital Oncológico Dr. Isaac González-Martinez | Rio Piedras | 00935 | Puerto Rico |
| Pan American Center for Oncology Trials, LLC | Rio Piedras | 00935 | Puerto Rico |
| Pan American Center for Oncology Trials- Hospital Oncologico | Rio Piedras | 00935 | Puerto Rico |
| Unrelease | Apr 30, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 16, 2025 | Aug 5, 2025 | |||
| Apr 30, 2026 | Apr 30, 2026 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract 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 |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D001749 | Urinary Bladder Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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