PF-08046037 + Sasanlimab for Non-Small Cell Lung Cancer

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Autoimmune disease, Neurodegenerative disease, Pulmonary disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Until disease progression or unacceptable toxicity

399 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called PF-08046037, alone or with sasanlimab (an immunotherapy), to determine its safety and effectiveness for certain advanced cancers, such as non-small cell lung cancer (NSCLC) and head and neck cancer. The study aims to find the optimal dose and assess how the cancer responds to these treatments. It seeks participants with these advanced cancers whose previous treatments are no longer effective. Participants will receive the medicines through infusions and injections, continuing as long as their cancer responds well. Regular clinic check-ups will track progress and any side effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for this trial?

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

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

Research shows that PF-08046037 and its combination with sasanlimab are still under study to ensure safety. No results from human trials are available yet. This trial is in an early stage, focusing on assessing the safety of these treatments. Researchers aim to identify any side effects and determine the correct dose in early trials.

Sasanlimab is tested alongside PF-08046037. Previous studies have provided some safety information on sasanlimab. However, when combined with a new drug like PF-08046037, researchers must ensure the combination's safety.

In summary, while some information exists on sasanlimab, the combination with PF-08046037 is new. Early trials are crucial for understanding its safety and tolerability. Participants in this trial will help researchers learn about any side effects and how people respond to these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08046037 and sasanlimab for non-small cell lung cancer because they offer a fresh approach compared to current treatments like chemotherapy and immune checkpoint inhibitors. PF-08046037 is unique as it targets a specific pathway thought to be crucial for cancer cell survival, potentially leading to more effective outcomes with fewer side effects. Sasanlimab, an immunotherapy, helps the immune system better recognize and attack cancer cells. Together, they might offer a powerful one-two punch in fighting this tough-to-treat cancer.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that PF-08046037, a drug that activates the immune system, has demonstrated promising effects against tumors in lab studies. It helps the immune system locate and attack cancer cells. Early research on PF-08046037 suggests it could effectively treat advanced cancers.

In this trial, some participants will receive PF-08046037 alone, while others will receive it in combination with sasanlimab, another treatment that boosts the immune system. Previous studies on combinations with sasanlimab showed a significant reduction in cancer-related issues. While these findings are promising, they primarily come from early-stage research. ^{1 2 3 4 6}

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 people with certain advanced cancers, including lung, skin, and pancreatic cancer. Participants must be able to provide tumor samples and have measurable disease. They will receive PF-08046037 alone or with sasanlimab during clinic visits every three weeks.

Inclusion Criteria

My cancer has worsened despite treatment.

I have advanced or metastatic NSCLC or PDAC.

I have advanced lung or head/neck cancer and haven't had immunotherapy or it didn't work.

Exclusion Criteria

Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist

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

I have an autoimmune disease that could worsen with immune-stimulating treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-08046037 alone as an IV infusion or with sasanlimab as a SQ injection every 3 weeks

Until disease progression or unacceptable toxicity

Regular visits at the study clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-37 days after the last study treatment

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• PF-08046037
• sasanlimab

Trial Overview The study tests the safety and effects of PF-08046037 by itself or combined with sasanlimab in treating advanced malignancies. Treatments are administered intravenously (PF-08046037) or as a subcutaneous injection (sasanlimab).

How Is the Trial Designed?

Group I: Part 3b Experimental Treatment 2 Interventions

PF-08046037 + sasanlimab dose expansion

Group II: Part 3a Experimental Treatment 1 Intervention

PF-08046037 monotherapy dose expansion

Group III: Part 2b Experimental Treatment 2 Interventions

PF-08046037 + sasanlimab dose optimization

Group IV: Part 2a Experimental Treatment 1 Intervention

PF-08046037 monotherapy dose optimization

Group V: Part 1b Experimental Treatment 2 Interventions

PF-08046037 +sasanlimab dose escalation

Group VI: Part 1a Experimental Treatment 1 Intervention

PF-08046037 monotherapy dose escalation

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06974734

NCT06974734 | A Clinical Trial of PF-08046037 Alone or ... The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or ...

2. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct06974734-carcinoma-trial

A Clinical Trial of PF-08046037 Alone or With Sasanlimab ... The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or ...

3. trial.medpath.com trial.medpath.com/clinical-trial/465540cd636eb4b7/nct06974734-pf-08046037-monotherapy-combination-advanced-malignancies

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in ... The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or ...

4. withpower.com withpower.com/trial/pf-08046037-sasanlimab-for-non-small-cell-lung-cancer-c513f

PF-08046037 + Sasanlimab for Non-Small Cell Lung Cancer The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or ...

5. 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 ...

6. ctv.veeva.com ctv.veeva.com/study/a-clinical-trial-of-pf-08046037-alone-or-with-sasanlimab-in-patients-with-advanced-or-metastatic-mal

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in ... The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain ...