PF-07265028 + Sasanlimab for Advanced Cancers

No longer recruiting at 12 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Active malignancy, Autoimmune diseases, Lung disease, CNS metastases, Cardiac conditions, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PF-07265028, both alone and with another drug, sasanlimab (an experimental treatment), to determine the safest and most effective doses for people with advanced cancers. Researchers aim to assess the treatments' effectiveness and potential side effects. The trial is divided into parts: initially to establish the right doses, then to test those doses on specific cancer types such as lung, gastric, and other solid tumors. This trial may suit individuals with advanced cancers unresponsive to other treatments, including at least one checkpoint inhibitor, and who do not have other active cancers or severe health issues. Participants must attend regular visits over up to a year. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that PF-07265028 is being tested for safety both alone and in combination with sasanlimab. Specific safety data for PF-07265028 alone is not yet available. However, the combination with sasanlimab has shown promising results. Studies of sasanlimab, a drug used in cancer treatments, suggest it can be safe at certain doses.

In earlier research, sasanlimab was generally well-tolerated, with some patients experiencing mild to moderate side effects like tiredness or a rash. Since this trial is in the early stages, it primarily focuses on determining the maximum safe dosage without causing serious side effects. This means the researchers are still learning about its safety.

If PF-07265028 receives approval for other treatments, it might also indicate safety. However, the study's main goal is to find the safest way to use these drugs for treating advanced cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-07265028 and sasanlimab because they offer a novel approach to tackling various advanced cancers, such as non-small cell lung cancer (NSCLC), gastric cancer, and urothelial cancer. Unlike standard treatments that typically involve chemotherapy or radiation, PF-07265028 works by targeting specific cancer cell pathways, potentially leading to more precise attacks on tumors with fewer side effects. Sasanlimab, an immunotherapy, boosts the body's immune response to better fight cancer cells. This combination aims to enhance treatment efficacy and offers hope for cases where traditional therapies have limited success.

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

Research shows that PF-07265028, both alone and with sasanlimab, is being tested in this trial for treating various advanced cancers. Participants in different treatment arms will receive either PF-07265028 alone or combined with sasanlimab. Studies have shown that when sasanlimab is used with other treatments, it reduces the risk of serious disease events, like cancer recurrence, by 32%. PF-07265028 is designed to block specific pathways that cancer cells need to grow. Early studies suggest it might help fight tumors by disrupting these growth signals. Although much remains to be learned about its effectiveness, these early results are promising. ^{1 6 7 8 9}

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 cancers like lung and stomach cancer, who've tried other treatments without success. They must have measurable disease, provide tumor tissue samples, be in good physical condition (ECOG ≤1), and have proper organ function.

Inclusion Criteria

You have a tumor that can be measured using specific guidelines for evaluating tumor response.

I need a recent tumor biopsy or have one from the last 3 months after my last cancer treatment.

I have recovered from the side effects of my previous treatments.

Exclusion Criteria

My cancer has spread to my brain.

I haven't had major heart or lung issues in the last 6 months.

I have a stomach or intestine problem that affects how my body absorbs medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of PF-07265028 as monotherapy and in combination with sasanlimab to determine the maximum tolerated dose

28 days per cycle

6 visits in the first month

Dose Expansion

Participants receive PF-07265028 at the recommended dose in combination with sasanlimab in selected tumor types

Up to 1 year

At least 2 visits per month

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07265028
• Sasanlimab

Trial Overview The study tests PF-07265028 alone and combined with Sasanlimab to find the highest dose patients can tolerate without severe side effects. It will also assess how well these treatments work against various solid tumors at this optimal dose over a period of up to one year.

How Is the Trial Designed?

Group I: Part 2B Dose Expansion Monotherapy (selected tumor types) Experimental Treatment 1 Intervention

Participants with selected tumor types will receive PF-07265028 single agent at the recommended dose from Part 1A.

Group II: Part 2A Dose Expansion Combination (selected tumor types) Experimental Treatment 2 Interventions

Participants with selected tumor types will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B

Group III: Part 2A Dose Expansion Combination (UC) Experimental Treatment 2 Interventions

Participants with urothelial cancer (UC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B

Group IV: Part 2A Dose Expansion Combination (SCCHN) Experimental Treatment 2 Interventions

Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B

Group V: Part 2A Dose Expansion Combination (NSCLC) Experimental Treatment 2 Interventions

Participants with non small cell lung cancer (NSCLC) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B

Group VI: Part 2A Dose Expansion Combination (Gastric/GEJ) Experimental Treatment 2 Interventions

Participants with gastric/gastroesophageal junction cancer (Gastric/GEJ) will receive PF-07265028 in combination with sasanlimab at the recommended dose from Part 1B

Group VII: Part 1B Dose Escalation Combination Experimental Treatment 2 Interventions

Participants will receive PF-07265028 at escalating dose levels in combination with sasanlimab fixed dose

Group VIII: Part 1A Dose Escalation Monotherapy Experimental Treatment 1 Intervention

Participants will receive PF-07265028 at escalating dose levels.

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 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]

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]

Cadonilimab, a bispecific PD-1/CTLA-4 antibody, demonstrated a manageable safety profile with 28% of patients experiencing grade 3-4 treatment-related adverse events, indicating it can be safely administered to patients with advanced solid tumors.

In a phase 2 trial, cadonilimab showed promising antitumor activity, with an objective response rate of 32.3% in cervical cancer patients, suggesting its potential effectiveness in treating advanced solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and antitumour activity of cadonilimab, an anti-PD-1/CTLA-4 bispecific antibody, for patients with advanced solid tumours (COMPASSION-03): a multicentre, open-label, phase 1b/2 trial. Gao, X., Xu, N., Li, Z., et al.[2023]

In a phase 2 trial involving 117 patients with advanced, refractory squamous non-small-cell lung cancer, nivolumab demonstrated a 14.5% objective response rate, indicating its potential effectiveness as a treatment option.

The safety profile of nivolumab was manageable, with 17% of patients experiencing severe treatment-related adverse events, suggesting that while there are risks, the benefits may outweigh them for patients with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Rizvi, NA., Mazières, J., Planchard, D., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2211383523004793

Small-molecule agents for cancer immunotherapy This study's goal was to assess the effectiveness and safety of PF-07265028 monotherapy and in combination with sasanlimab (anti-PD-1 monoclonal antibody) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05233436

Study Details | NCT05233436 | PF-07265028 As Single ... The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab.

3. bcan.org bcan.org/clinicaltrials/pf-07265028-as-single-agent-and-in-combination-with-sasanlimab-in-advanced-or-metastatic-solid-tumors/

PF-07265028 As Single Agent And In Combination With ... Part 1A Monotherapy: Histologically or cytologically confirmed advanced or metastatic solid tumors which have progressed following systemic anticancer therapies ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39651809/

Discovery of PF-07265028, A Selective Small Molecule ... We present highlights of the drug discovery campaign within the lactam/azalactam series of inhibitors that yielded a small molecule (21, PF-07265028),

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10644399/

Small molecule inhibitors for cancer immunotherapy and ... Here, we present the status of the most promising small molecule drug candidates for cancer immunotherapy, all residing relatively early in development,

6. withpower.com withpower.com/trial/phase-1-stomach-neoplasms-1-2022-f0ccf

PF-07265028 + Sasanlimab for Advanced Cancers This trial is for adults with advanced or metastatic solid tumors, including specific cancers like lung and stomach cancer, who've tried other treatments ...

7. pubs.acs.org pubs.acs.org/doi/abs/10.1021/acs.jmedchem.4c01930

Discovery of PF-07265028, A Selective Small Molecule ... We present highlights of the drug discovery campaign within the lactam/azalactam series of inhibitors that yielded a small molecule (21, PF-07265028),

8. ctv.veeva.com ctv.veeva.com/study/pf-07265028-as-single-agent-and-in-combination-with-sasanlimab-in-advanced-or-metastatic-solid-tumor

PF-07265028 As Single Agent And In Combination With ... The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-09414

PF-07265028 As Single Agent And In Combination With ... The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab. The study aims to identify ...