What side effects are associated with this type of intervention?

Common treatments for stomach cancer, particularly advanced stages, often involve targeted therapies and immunotherapies. Side effects for these treatments can include diarrhea, rash, nausea, and fatigue. Specific to immunotherapies like sasanlimab, patients may experience immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Targeted therapies may also cause hypertension, hand-foot syndrome, and proteinuria. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for stomach cancer, including immunotherapy and targeted agents. Pembrolizumab, an anti-PD-1 monoclonal antibody, is approved for PD-L1-positive advanced gastric or gastroesophageal junction adenocarcinoma. Additionally, ramucirumab, a VEGFR-2 antagonist, is approved for use as a monotherapy or in combination with paclitaxel for advanced gastric cancer. Trastuzumab, a HER2 inhibitor, is approved for HER2-positive gastric cancer in combination with chemotherapy. These treatments reflect the trend towards using targeted and immunotherapeutic approaches in managing advanced stomach cancer.

What other types of research exist?

Promising novel alternatives for stomach cancer treatment in 2024 include: 1) Perioperative ramucirumab in combination with FLOT chemotherapy, as studied in the RAMSES/FLOT7 trial. 2) Perioperative atezolizumab combined with FLOT chemotherapy, as indicated by interim results from the DANTE trial. 3) Durvalumab combined with FLOT chemotherapy, as assessed in ongoing clinical trials. These combinations have shown potential in improving surgical and pathological outcomes in resectable esophagogastric adenocarcinoma.

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PF-07265028 + Sasanlimab for Advanced Cancers

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed advanced or metastatic malignancies, including gastric/Gastroesophageal junction cancer, Head and neck squamous cell carcinoma, or urothelial cancer (non-small cell lung cancer and other solid tumors may be included) who have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor

Histologically or cytologically confirmed advanced or metastatic solid tumor which have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor

Must not have

Central nervous system metastases

Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PF-07265028

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions to cancer therapies such as immune-related issues due to Sasanlimab (an immunotherapy drug) and any adverse effects related to PF-07265028's action on the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened after treatment, including a checkpoint inhibitor.

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My advanced cancer has worsened after treatment, including an immunotherapy drug.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain.

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

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I have not had any other cancer in the last 3 years.

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I have a history of lung conditions like interstitial lung disease or pneumonitis.

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I have had severe side effects from previous immune therapy.

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I have never taken HPK1 inhibitor medication.

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I do not have any ongoing serious infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with Dose-limiting toxicities (DLTs) in Dose Escalation (Part 1)

Number of participants with adverse events (AEs)

Number of participants with clinically significant laboratory abnormalities

+1 more

Secondary study objectives

ORR in Dose Escalation (Part 1)

The effect of PF-07265028 alone and in combination with sasanlimab on tumor immune biomarkers modulation

The effect of food on the pharmacokinetic profile of PF-07265028 through AUC

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part 2B Dose Expansion Monotherapy (selected tumor types)Experimental Treatment1 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 Treatment2 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 Treatment2 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 Treatment2 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 Treatment2 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 Treatment2 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 CombinationExperimental Treatment2 Interventions

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

Group VIII: Part 1A Dose Escalation MonotherapyExperimental Treatment1 Intervention

Participants will receive PF-07265028 at escalating dose levels.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stomach cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, but it also affects normal cells, leading to side effects. Targeted therapies, such as those inhibiting VEGFR-2 (e.g., apatinib), focus on specific molecules involved in cancer growth and spread, offering a more precise approach with potentially fewer side effects. Immunotherapy, including immune checkpoint inhibitors like pembrolizumab and nivolumab, enhances the body's immune response against cancer cells. The combination therapy being studied in the PF-07265028 trial with sasanlimab (an immunotherapy agent) aims to boost the immune system's ability to fight cancer more effectively. Understanding these mechanisms is crucial for stomach cancer patients as it helps tailor treatments to individual needs, potentially improving outcomes and minimizing adverse effects.

A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study.Molecular-targeted therapy for chemotherapy-refractory gastric cancer: a case report and literature review.A systematic overview of chemotherapy effects in gastric cancer.