AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES

Phase 1 trial of PF-08046037 alone or with sasanlimab in advanced cancers

NCT: NCT06974734 · Status: ACTIVE NOT RECRUITING · Phase: Phase 1 · Sponsor: Pfizer · Started: 2025-05-06 · Est. Completion: 2026-04-30

Plain English Summary

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies is a Phase 1 clinical trial sponsored by Pfizer studying Carcinoma, Non Small Cell Lung, Carcinoma, Pancreatic Ductal, Malignant Melanoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN). This trial tests a new drug, PF-08046037, by itself or combined with another drug called sasanlimab. It is for adults with advanced or metastatic non-small cell lung cancer, pancreatic cancer, melanoma, or head and neck cancer. Participation involves receiving study drugs via IV or under the skin, with regular clinic visits for monitoring. Alternative treatments may include standard chemotherapy, targeted therapies, or other immunotherapies depending on the cancer type and prior treatments. The trial aims to enroll 9 participants.

Official Summary

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 metastatic malignancies. This study is seeking participants who: * have advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, or pancreatic ductal adenocarcinoma (PDAC); * are able to provide tumor tissue samples; * have measurable disease. All participants will receive while at the clinic PF-08046037 alone as an intravenous (IV) infusion (given directly into a vein) or with sasanlimab as a subcutaneous (SQ) injection (given under the skin) once every 3 weeks. Participants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with specific types of advanced or metastatic lung, pancreatic, melanoma, or head and neck cancers. Patients must be able to provide tumor tissue samples and have measurable disease. Specific eligibility varies by treatment arm, with some requiring prior treatments and others not. Individuals with a history of severe immune-related side effects from prior immunotherapy or active autoimmune disease may not be eligible. This trial is studying Carcinoma, Non Small Cell Lung, Carcinoma, Pancreatic Ductal, Malignant Melanoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN), so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure the safety of the study drugs by tracking side effects, laboratory changes, and dose adjustments, helping to determine a safe dose for future studies. The specific primary outcome measures are: Number of participants with adverse events (AEs) (Through 30-37 days after the last study treatment, up to approximately 2 years); Number of participants with laboratory abnormalities (Through 30-37 days after the last study treatment, up to approximately 2 years); Number of dose modifications due to AEs (Through end of treatment up to approximately 2 years); Number of participants with dose-limiting toxicities (DLTs) (Up to 21 days); Number of participants with DLTs by dose level (Up to 21 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial explores a new treatment approach for advanced cancers, aiming to fill a gap for patients who have not responded to or have progressed on existing therapies. This research targets Carcinoma, Non Small Cell Lung, Carcinoma, Pancreatic Ductal, Malignant Melanoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN), where improved treatment options are needed.

Investor Insight

This Phase 1 trial by Pfizer is an early-stage investigation of a novel combination therapy, indicating potential for new treatment options in oncology with implications for market competition and fut Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific treatment plan for your cancer type and if you meet the eligibility criteria. Be prepared for regular clinic visits for drug infusions/injections and monitoring of your health and response to treatment. Understand that this is an early-stage trial, and the main goal is to assess safety and find the right dose. The trial is being conducted at 15 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below.

1. Tumor types

   * Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts

     * Advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC
     * Must have progressive disease following at least 1 prior approved systemic therapy
   * Monotherapy Dose Expansion (Part 3a)

     • Advanced or metastatic NSCLC or PDAC
   * Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b)

     * Advanced or metastatic NSCLC or HNSCC
     * May be either a) not received prior immunotherapy for the tumor type OR b) relapse/ refractory after prior immunotherapy
   * Combination Dose Expansion (Part 3b)

     * Unresectable locally advanced or metastatic HNSCC or NSCLC
     * Must not have received prior systemic cytotoxic therapy in the locally advanced or metastatic setting (first-line setting)
     * Must be treatment naïve to any immunotherapy
     * NSCLC must have PD-L1 expression TPS \>=50%
     * HNSCC must have PD-L1 expression CPS \>=1
2. Tissue requirement

   * Part 1 at lower doses: sufficient archival tissue collected within 12 months of enrollment for submission to central laboratory
   * Part 1 at higher doses: de novo baseline tumor biopsy or archival tissue within 12 months of enrollment
   * Part 1 backfill: de novo baseline and on-treatment tumor biopsies are required
   * Part 2 and 3: de novo baseline or archival tissue within 6 months of enrollment
   * Part 2 and 3: mandatory on-treatment tumor biopsy, if required by sponsor
3. Measurable disease per RECIST v1.1

Participants who meet the following might not be able to participate.

1. History of Grade \>=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy
2. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent
3. History of uveitis within the preceding 6 months
4. Clinically significant Grade \>=3 neurodegenerative disease
5. Grade 3 or higher pulmonary disease unrelated to underlying malignancy
6. Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06974734?

NCT06974734 is a Phase 1 INTERVENTIONAL study titled "A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies." It is currently active, not recruiting and is sponsored by Pfizer. The trial targets enrollment of 9 participants.

What conditions does NCT06974734 study?

This trial investigates treatments for Carcinoma, Non Small Cell Lung, Carcinoma, Pancreatic Ductal, Malignant Melanoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN). The primary condition under study is Carcinoma, Non Small Cell Lung.

What treatments are being tested in NCT06974734?

The interventions being studied include: PF-08046037 (DRUG), sasanlimab (DRUG). Given into the vein (IV; intravenous)

What does Phase 1 mean for NCT06974734?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT06974734?

This trial is currently "Active, Not Recruiting." It started on 2025-05-06. The estimated completion date is 2026-04-30.

Who is sponsoring NCT06974734?

NCT06974734 is sponsored by Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06974734?

The trial aims to enroll 9 participants. The trial status is active, not recruiting.

How is NCT06974734 designed?

This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT06974734?

The primary outcome measures are: Number of participants with adverse events (AEs) (Through 30-37 days after the last study treatment, up to approximately 2 years); Number of participants with laboratory abnormalities (Through 30-37 days after the last study treatment, up to approximately 2 years); Number of dose modifications due to AEs (Through end of treatment up to approximately 2 years); Number of participants with dose-limiting toxicities (DLTs) (Up to 21 days); Number of participants with DLTs by dose level (Up to 21 days). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06974734 being conducted?

This trial is being conducted at 15 sites, including Denver, Colorado; New Haven, Connecticut; Trumbull, Connecticut; Indianapolis, Indiana and 11 more sites (United States, Puerto Rico).

Where can I find official information about NCT06974734?

The official record for NCT06974734 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06974734. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06974734 testing in simple terms?

This trial tests a new drug, PF-08046037, by itself or combined with another drug called sasanlimab. It is for adults with advanced or metastatic non-small cell lung cancer, pancreatic cancer, melanoma, or head and neck cancer.

Why is this trial significant?

This trial explores a new treatment approach for advanced cancers, aiming to fill a gap for patients who have not responded to or have progressed on existing therapies.

What are the potential risks of participating in NCT06974734?

The most common risks include side effects related to the immune system, as these drugs work by stimulating the immune system. Potential side effects can range from mild (like fatigue or rash) to severe, requiring medical attention. Specific risks include immune-mediated reactions affecting organs like the lungs, liver, or skin. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06974734?

Ask your doctor about the specific treatment plan for your cancer type and if you meet the eligibility criteria. Be prepared for regular clinic visits for drug infusions/injections and monitoring of your health and response to treatment. Understand that this is an early-stage trial, and the main goal is to assess safety and find the right dose. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06974734 signal from an investment perspective?

This Phase 1 trial by Pfizer is an early-stage investigation of a novel combination therapy, indicating potential for new treatment options in oncology with implications for market competition and fut This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves receiving study drugs via IV or under the skin, with regular clinic visits for monitoring. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.