PF-07265028 + Sasanlimab for Advanced Cancers

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

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug (PF-07265028) alone and with another drug (sasanlimab) in patients with certain types of tumors. The goal is to find the safest dose and see if the drugs help treat the tumors.

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.

What data supports the effectiveness of the drug PF-07265028 + Sasanlimab for advanced cancers?

Sasanlimab, a part of the treatment, is an antibody that targets the PD-1 receptor, which is known to help the immune system fight cancer. Similar drugs that target PD-1, like nivolumab and dostarlimab, have shown benefits in treating various advanced cancers, suggesting potential effectiveness for Sasanlimab in this combination. ^{1 2 3 4 5}

How is the drug PF-07265028 + Sasanlimab unique for advanced cancers?

The combination of PF-07265028 and Sasanlimab is unique because it involves a novel pairing of treatments that may work together to enhance the immune system's ability to fight cancer, potentially offering a new option for patients with advanced cancers where standard treatments are limited or ineffective. ^{5 6 7 8 9}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England 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. [2023]

2. France 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dostarlimab: From preclinical investigation to drug approval and future directions. [2023]

4. England 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. [2023]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Panitumumab Plus Fluorouracil and Folinic Acid Versus Fluorouracil and Folinic Acid Alone as Maintenance Therapy in RAS Wild-Type Metastatic Colorectal Cancer: The Randomized PANAMA Trial (AIO KRK 0212). [2023]

7. England pubmed.ncbi.nlm.nih.gov

A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). [2022]

8. Greece pubmed.ncbi.nlm.nih.gov

Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy, safety and predictors of combined fruquintinib with programmed death-1 inhibitors for advanced microsatellite-stable colorectal cancer: A retrospective study. [2022]