PF-07826390 for Cancer

No longer recruiting at 13 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Immunosuppressants

Disqualifiers: Autoimmune disease, Organ dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the new treatment, PF-07826390, is safe and effective for individuals with advanced or metastatic solid tumors, such as certain lung, colon, or kidney cancers. Participants will receive this treatment alone or with another medicine, sasanlimab, to identify the most effective option. The study seeks individuals whose cancer has not responded to previous treatments or has spread. Participants should be prepared for weekly visits for up to four years to monitor progress. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic anticancer therapy at least 4 weeks before starting the study medication. However, the protocol does not specify about other medications, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that PF-07826390, a new cancer treatment, is still under safety evaluation. As it is in the early testing stages, detailed safety information is not yet available. This phase focuses on understanding how the treatment works in the body and whether any side effects are manageable.

Sasanlimab, when combined with PF-07826390, is also under study. Previous research on sasanlimab alone assessed its safety for treating bladder cancer. However, using it with PF-07826390 is new, and researchers are now evaluating the tolerability of this combination.

In summary, both PF-07826390 and its combination with sasanlimab are still under investigation to ensure they are safe and tolerable. This trial aims to gather more information about their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07826390 because it represents a novel approach in cancer treatment, differentiating itself from the standard of care like chemotherapy and immunotherapy. Most current treatments target cancer cells directly or enhance the immune system's ability to attack them. However, PF-07826390 might offer a new mechanism of action that could complement existing therapies. Its combination with sasanlimab, an innovative agent that could further boost immune response, is particularly promising. Additionally, the treatment's potential to be effective in various cancers, such as non-small cell lung cancer (NSCLC), colorectal cancer (MSS CRC), and renal cell carcinoma (RCC), highlights its versatility and broad applicability.

What evidence suggests that this trial's treatments could be effective for cancer?

Research shows that PF-07826390 is still under testing, and its effectiveness remains uncertain. This experimental drug targets specific proteins that may aid cancer cell growth. In this trial, some participants will receive PF-07826390 as monotherapy, while others will receive it with another drug, sasanlimab, which has shown promise in other research. Specifically, sasanlimab has been effective in slowing cancer progression in some cases. Additionally, one study arm combines PF-07826390 with standard-of-care treatments. The goal of these combinations is to determine if they are more effective against solid tumors like non-small cell lung cancer, colorectal cancer, and kidney cancer. Although more results are pending, early studies suggest that combining sasanlimab with other treatments can significantly improve outcomes in certain cancers. ^{1 2 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors, including specific types of lung, colorectal, and kidney cancers. Participants must have tried certain standard treatments without success or be unable to tolerate them. They should have at least one measurable tumor lesion and be able to provide tissue samples.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.

My cancer has worsened despite previous anti-PD-(L)1 therapy.

I have NSCLC and have been treated with platinum-based chemo and anti-PD-(L)1 or cannot tolerate standard treatments.

Exclusion Criteria

My kidney, liver, and bone marrow are not working well.

I had a severe reaction to previous immune therapy that needed treatment.

I haven't had cancer treatment in the last 4 weeks or 5 half-lives, whichever is shorter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-07826390 as an IV infusion every four weeks in 28-day cycles, alone or in combination with sasanlimab

Up to 2 years

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after stopping the study medication

2 years

Regular follow-up visits

Extension

Participants may continue to receive PF-07826390 until their cancer is no longer responding

Up to 4 years total participation

What Are the Treatments Tested in This Trial?

Interventions

• PF-07826390
• sasanlimab
• SOC

Trial Overview The study tests PF-07826390 alone or combined with sasanlimab (an anti-cancer medication) in people with cancer. It aims to determine the safest and most effective dosage. Patients will receive these medications through IV infusion or shots under the skin every four weeks.

How Is the Trial Designed?

Group I: Part 2C: PF-07826390 + SOC Experimental Treatment 2 Interventions

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

Group II: Part 2B: PF-07826390 Experimental Treatment 1 Intervention

PF-07826390 dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles

Group III: Part 2A (Arm 3): PF-07826390 + sasanlimab Experimental Treatment 2 Interventions

PF-07826390 + sasanlimab dose expansion in RCC 2L+ at prescribed dose and frequency in 28-day cycles

Group IV: Part 2A (Arm 2): PF-07826390 + sasanlimab Experimental Treatment 2 Interventions

PF-07826390 + sasanlimab dose expansion in MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles

Group V: Part 2A (Arm 1): PF-07826390 + sasanlimab Experimental Treatment 2 Interventions

PF-07826390 + sasanlimab dose expansion in NSCLC 2L+ at prescribed dose and frequency in 28-day cycles

Group VI: Part 1B: PF-07826390 + sasanlimab Experimental Treatment 2 Interventions

PF-07826390 + sasanlimab at prescribed dose and frequency in 28-day cycles

Group VII: Part 1A: PF-07826390 Monotherapy Experimental Treatment 1 Intervention

PF-07826390 monotherapy at prescribed dose and frequency in 28-day cycles

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Sasanlimab, an anti-PD-1 monoclonal antibody, shows efficacy in treating advanced solid tumors, with response significantly associated with baseline tumor mutational burden (TMB), PD-L1, and CD8 expression in a study involving 38 patients.

The study highlights that higher expression levels of genes related to interferon-γ and PD-1 signaling pathways correlate with better responses to sasanlimab, indicating its immunomodulatory mechanism across various tumor types and administration routes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Tumor Mutational Burden and Immune Gene Expression with Response to PD-1 Blockade by Sasanlimab Across Tumor Types and Routes of Administration. Hu-Lieskovan, S., Braiteh, F., Grilley-Olson, JE., et al.[2022]

In a study of 397 patients with nonsquamous non-small cell lung cancer (NSCLC), the combination of sintilimab and chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone, with a median OS not reached versus 16.8 months for the placebo group.

High expression of the MHC class II antigen presentation pathway was strongly associated with better progression-free survival (PFS) and OS, indicating that this biomarker could help identify patients who would benefit most from the sintilimab and chemotherapy combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated Overall Survival Data and Predictive Biomarkers of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC in the Phase 3 ORIENT-11 Study. Yang, Y., Sun, J., Wang, Z., et al.[2021]

Anlotinib significantly improved overall survival (OS) and progression-free survival (PFS) in patients with non-small cell lung cancer (NSCLC) regardless of their EGFR mutation status, with OS of 10.7 months for EGFR-positive patients and 8.9 months for EGFR-negative patients compared to placebo.

The efficacy of anlotinib was demonstrated through substantial improvements in PFS as well, with 5.6 months for EGFR-positive and 5.4 months for EGFR-negative patients, indicating that anlotinib is a viable third-line treatment option for NSCLC patients irrespective of their genetic profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of anlotinib as third-line treatment for non-small cell lung cancer by EGFR mutation status: a subgroup analysis of the ALTER0303 randomized phase 3 study. Zhao, Y., Wang, Q., Zhang, L., et al.[2022]

Pucotenlimab is a monoclonal antibody that targets PD-1, effectively blocking its interaction with PD-L1 and PD-L2, which helps restore immune cell function against various solid tumors.

In July 2022, pucotenlimab received conditional approval in China for treating advanced solid tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) characteristics, particularly after previous therapies have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pucotenlimab: First Approval. Dhillon, S.[2022]

Axitinib is an oral medication that inhibits key receptors involved in tumor growth and has shown activity against various solid tumors, including thyroid, pancreatic, lung, and breast cancers, based on Phase II trials.

While common side effects include fatigue and hypertension, axitinib was generally well tolerated, and larger randomized studies were underway to further evaluate its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axitinib, a novel anti-angiogenic drug with promising activity in various solid tumors. Choueiri, TK.[2018]

In a meta-analysis of 27 randomized controlled trials involving 15,590 patients with advanced non-small cell lung cancer, treatment effect sizes for progression-free survival (PFS) and overall survival (OS) were found to be comparable, suggesting that PFS can be a reliable endpoint in clinical trials.

However, the analysis indicated that PFS may not be as reliable for trials using immunotherapy as a second-line treatment, highlighting the need for caution when interpreting PFS data without OS outcomes in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in treatment effect size between progression-free survival and overall survival in anti-PD-1/PD-L1 inhibitors-based trials in advanced NSCLC: a systematic review and meta-analysis. Zhou, Z., Ren, S., Chen, L., et al.[2022]

In a phase 2 trial involving 33 patients with advanced sarcomas, the combination of axitinib and pembrolizumab showed a promising 3-month progression-free survival rate of 65.6%, with even higher rates of 72.7% for patients with alveolar soft-part sarcoma (ASPS).

The treatment was associated with manageable side effects, with 21% of patients experiencing serious adverse events, but no treatment-related deaths, indicating a favorable safety profile for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axitinib plus pembrolizumab in patients with advanced sarcomas including alveolar soft-part sarcoma: a single-centre, single-arm, phase 2 trial. Wilky, BA., Trucco, MM., Subhawong, TK., et al.[2020]

In a phase II trial involving 25 patients with RAS-mutant, microsatellite stable metastatic colorectal cancer, the combination of sintilimab, bevacizumab, oxaliplatin, and capecitabine showed a high objective response rate of 84% and a disease control rate of 100%, indicating promising anti-tumor activity.

The treatment was generally well-tolerated, with manageable adverse events; the most common were anemia and neutropenia, but no grade 5 adverse events occurred, suggesting a favorable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sintilimab plus bevacizumab, oxaliplatin and capecitabine as first-line therapy in RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer: an open-label, single-arm, phase II trial. Fang, X., Zhu, N., Zhong, C., et al.[2023]

Sasanlimab, an antibody targeting the PD-1 receptor, was well tolerated in patients with non-small-cell lung cancer (NSCLC) and urothelial carcinoma, with only 13.2% experiencing severe treatment-related side effects.

The treatment showed promising efficacy, with objective response rates of 16.4% in NSCLC and 18.4% in urothelial carcinoma, particularly in patients with high PD-L1 expression and tumor mutational burden, suggesting it may be a viable option for these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase Ib/II dose expansion study of subcutaneous sasanlimab in patients with locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma. Cho, BC., Penkov, K., Bondarenko, I., et al.[2023]

In a multicenter phase II study involving 53 Japanese patients with advanced colorectal cancer, the FOLFOX4 regimen (oxaliplatin, levoforinate, and infusional 5-fluorouracil) demonstrated a partial response rate of 20.8%, indicating its efficacy as a second-line therapy.

The treatment showed good tolerability, with manageable toxicity, primarily neutropenia occurring in 43.1% of patients, suggesting that FOLFOX4 is a promising option for patients who have not responded to first-line chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as second-line treatment for advanced colorectal cancer: a Japanese experience. Ogata, Y., Tokunaga, S., Emi, Y., et al.[2021]

Citations

1. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-press-releases/159966-pfizer-s-sasanlimab-combination-significantly-improves-event-free-survival-in-bcg-naive-high-risk-non-muscle-invasive-bladder-cancer.html

Pfizer's Sasanlimab Combination Significantly Improves ... Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or progression, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06546553

NCT06546553 | A Study to Learn About How Different ... 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 ...

3. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-significantly-improves-event

Pfizer's Sasanlimab Combination Significantly Improves ... Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40450141/

Sasanlimab plus BCG in BCG-naive, high-risk non-muscle ... Sasanlimab is the first anti-PD-1 antibody to show a clinically meaningful prolongation of EFS when combined with BCG-I+M versus SOC in patients with BCG-naive ...

5. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/clinical_trial/NCT06546553

LILRB1/2 Bispecific IgG1 Antibody PF-07826390 is an investigational compound. Its safety and efficacy have not been established. FIRST-IN-HUMAN (FIH), OPEN-LABEL, PHASE 1 DOSE ESCALATION AND ...

6. bcan.org bcan.org/clinicaltrials/sasanlimab-pf-06801591-in-combination-with-bacillus-calmette-guerin-bcg-in-participants-with-high-risk-non-muscle-invasive-bladder-cancer/

Sasanlimab (PF-06801591) in Combination With Bacillus ... The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.

7. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/clinical_trial/NCT04165317

Sasanlimab Sasanlimab. Sasanlimab is an investigational compound. Its safety and efficacy have not been established. A Phase 3, Multinational, Randomized, Open-Label, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04165317

NCT04165317 | A Study of Sasanlimab in People With Non ... The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.