An Open-Label Phase 1 Study to Evaluate PF-08046032 as Monotherapy and Part of Combination Therapy in Participants With Advanced Malignancies

Plain English Summary

A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers is a Phase 1 clinical trial sponsored by Pfizer studying Peripheral T Cell Lymphoma, Diffuse Large B-cell Lymphoma, Classical Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, Melanoma, Non-Small Cell Lung Cancer. This trial tests a new drug called PF-08046032, alone and with another drug (sasanlimab), for advanced cancers. It is for adults with certain types of lymphomas or solid tumors that have not responded to or have worsened after standard treatments. Participants will receive the study drug(s) through IV infusion or under-the-skin injections. Alternative treatments depend on the specific cancer type and prior treatments received. The trial aims to enroll 6 participants.

Official Summary

The purpose of this study is to learn about the effects of a new study medicine called PF-08046032, when taken alone and when taken with another medicine called sasanlimab, for the treatment of advanced cancers. The effects are studied in adult participants with certain types of lymphomas or solid tumors that are advanced or metastatic (spread to other parts of the body). The study has three parts: * Part A will test PF-08046032 alone at increasing dose levels in participants with certain lymphomas (cancer that begins in cells of the immune system) and in participants with certain solid tumors whose disease has worsened on or after standard treatments. * Part B will test PF-08046032 (at selected doses) and sasanlimab in participants with certain solid tumors, including those whose disease has worsened on or after standard treatments as well as participants before receiving standard treatments. * Part C will further test the combination of PF-08046032 and sasanlimab in participants with specific types of solid tumors based on the results from Part A and Part B of the study. All participants will receive the study drug PF-08046032. Only participants in Part B and Part C of the study will also receive sasanlimab. PF-08046032 will be given as an intravenous (IV) infusion, which means it will be injected directly into a vein. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with specific types of advanced lymphomas or solid tumors. Patients whose cancer has worsened or returned after standard treatments. Patients with certain solid tumors may be eligible even if they haven't had prior immunotherapy. Individuals must have a performance status score of 0 or 1 (meaning they are able to carry out all self-care and do light work). This trial is studying Peripheral T Cell Lymphoma, Diffuse Large B-cell Lymphoma, Classical Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, Melanoma, Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how safe the study drugs are by tracking side effects, dose adjustments, and changes in lab results, helping to determine the right dose for future studies. The specific primary outcome measures are: Part A and Part B: Number of participants with dose limiting toxicities (DLTs) in dose escalation (Day of first dose (Day 1) through the end of DLT Observation period (up to 28 days)); All Parts: Number of participants with adverse events (AEs) (From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab); All Parts: Frequency of dose modifications due to AEs (From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab); All Parts: Number of participants with clinically significant lab abnormalities (From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab). 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 is important because it explores a new treatment combination for advanced cancers that have limited options, potentially filling a gap in current therapies. This research targets Peripheral T Cell Lymphoma, Diffuse Large B-cell Lymphoma, Classical Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, Melanoma, Non-Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This Phase 1 trial by Pfizer is an early-stage investigation into a novel drug combination for difficult-to-treat cancers, indicating a potential new therapeutic avenue in a competitive oncology marke Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific cancer and if you meet all the requirements. Be prepared for regular clinic visits for drug infusions/injections and monitoring of side effects. You may need to provide tumor tissue samples for analysis. The trial is being conducted at 4 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

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 6 participants

Interventions

• DRUG: PF-08046032 — PF-08046032 will be administered intravenously (IV) infusion.
• DRUG: Sasanlimab — Sasanlimab will be administered as subcutaneous (SC) injection.

Primary Outcomes

• Part A and Part B: Number of participants with dose limiting toxicities (DLTs) in dose escalation (Day of first dose (Day 1) through the end of DLT Observation period (up to 28 days))
• All Parts: Number of participants with adverse events (AEs) (From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab)
• All Parts: Frequency of dose modifications due to AEs (From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab)
• All Parts: Number of participants with clinically significant lab abnormalities (From first dose (Day 1) through up to 30 days after last dose of PF-08046032 or up to 90 days after last dose of sasanlimab)

Secondary Outcomes

• Objective Response Rate (ORR) in Participants with Solid Tumors (Response assessments at baseline and every 8 to 12 weeks through time of disease progression, death, unacceptable toxicity, or through study completion (Approximately 3 Years))
• Duration of Response (DoR) in Participants with Solid Tumors (Time from first documented objective response to the date of first documented radiographic progression or death (Approximately 3 Years))
• Progression-free survival (PFS) in Participants with Solid Tumors (Time from first dose (Day 1) to the date of first documented radiographic progression or death (Approximately 3 Years))
• Objective Response Rate (ORR) in participants with lymphomas based on Lugano Criteria (Response assessments at baseline and every 8 to 12 weeks through time of disease progression, death, unacceptable toxicity, or through study completion (Approximately 3 Years))
• Progression-free survival (PFS) in participants with lymphomas based on Lugano Criteria (Time from first dose (Day 1) to the date of first documented radiographic progression or death (Approximately 3 Years))

Full Eligibility Criteria

INCLUSION CRITERIA:

1. Histological or cytological diagnosis of metastatic or unresectable malignancy:

   * Part A1: Participants with lymphomas (cHL, PTCL, large B-cell lymphoma) who have progressed on/after standard therapies
   * Part A2: Participants with solid tumors (NSCLC, HNSCC, melanoma, or other limited tumor types) who have progressed on or following prior immune checkpoint inhibitor if indicated and available
   * Part B: Participants with solid tumors who have either progressed on/after prior immune checkpoint inhibitor, or who have not received prior immune checkpoint inhibitor therapy
   * Part C: Participants with selected tumor type who have not received systemic anticancer treatment for the tumor type (including prior immune checkpoint inhibitor
2. Measurable disease as defined by Lugano Classification for lymphomas or RECIST 1.1 for solid tumors
3. Able to provide tumor tissue(s) as defined by the protocol depending on the Part of the study at enrollment
4. ECOG Performance Status score 0 or 1

EXCLUSION CRITERIA:

1. Ongoing peripheral neuropathy
2. History of significant immune-mediated adverse event considered related to prior immune-modulatory therapy
3. Known or suspected active autoimmune disease

Trial Locations

• NEXT Oncology, San Antonio, Texas, United States
• Fred Hutchinson Cancer Center., Seattle, Washington, United States
• University of Washington Medical Center- Montlake, Seattle, Washington, United States
• Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain

Frequently Asked Questions

Related Conditions

• Peripheral T Cell Lymphoma
• Diffuse Large B-cell Lymphoma
• Classical Hodgkin Lymphoma
• Head and Neck Squamous Cell Carcinoma
• Melanoma
• Non-Small Cell Lung Cancer
• Advanced Cancers
• Metastatic Cancers
• Lymphoma
• Solid Tumors

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