What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, particularly those involving pembrolizumab (a PD-1 inhibitor), often include chemotherapy and immunotherapy combinations. Known side effects of these treatments can include fatigue, nausea, diarrhea, and decreased appetite. More severe adverse effects may include immune-related reactions such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. The incidence of severe (≥grade 3) treatment-related adverse effects is generally lower with pembrolizumab compared to chemotherapy alone. However, the combination of immunotherapy and chemotherapy can still lead to significant toxicities, necessitating careful monitoring and management.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been FDA-approved for the treatment of advanced or metastatic esophageal squamous cell carcinoma (ESCC), particularly in patients with PD-L1-positive tumors. This approval was based on the KEYNOTE-181 trial, which showed its efficacy over chemotherapy in second-line therapy. Nivolumab, another PD-1 inhibitor, has also received approval for similar indications, underscoring the importance of immune checkpoint inhibitors in esophageal cancer treatment.

What other types of research exist?

Promising alternatives for esophageal cancer treatment include Avelumab (anti-PD-L1) and Sintilimab (PD-1 inhibitor). Avelumab has shown antitumor activity and safety in patients with advanced gastric/gastroesophageal cancer, while Sintilimab demonstrated a significant improvement in overall survival compared to chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma.

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Monoclonal Antibodies

NGM707 + Pembrolizumab for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by NGM Biopharmaceuticals, Inc

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy

Performance status of 0 or 1

Must not have

Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called NGM707, both by itself and with another drug, Pembrolizumab. It targets patients with very advanced or spreading solid tumors. The treatment aims to boost the immune system to better fight cancer.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors who have tried all other treatments without success, or can't tolerate them, and are in good physical condition. They must have recovered from previous therapy side effects and have proper bone marrow, kidney, and liver function.

What is being tested?

The study tests NGM707 alone or combined with pembrolizumab to treat various cancers. It aims to see how well these treatments work on their own or together against different types of advanced cancer.

What are the potential side effects?

Possible side effects include immune system reactions that may affect organs, fatigue, skin issues like rash, digestive problems such as diarrhea or nausea, hormonal gland changes causing symptoms like headache or dizziness.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced or has spread and was confirmed by a lab test.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have not had treatments targeting ILT2/ILT4 or HLA-G.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Duration of Response for Patients in Expansion Cohorts

Incidence of Adverse Events

Number of Patients in Expansion Cohorts with Objective Responses

+4 more

Secondary study objectives

Anti-drug Antibodies (ADA) Against NGM707

Area Under the Curve (AUC) of Plasma NGM707

Observed Plasma Concentration of NGM707 (Including Cmax)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: NGM707 Monotherapy Dose Expansion Arm CExperimental Treatment1 Intervention

NGM707 in Ovarian Cancer

Group II: NGM707 Monotherapy Dose Expansion Arm BExperimental Treatment1 Intervention

NGM707 in CRC

Group III: NGM707 Monotherapy Dose Expansion Arm AExperimental Treatment1 Intervention

NGM707 in RCC

Group IV: NGM707 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Part 1a Single Agent Dose Escalation

Group V: NGM707 Combination Dose Finding with pembrolizumabExperimental Treatment1 Intervention

Part 1b NGM707 plus pembrolizumab

Group VI: NGM707 Combination Dose Expansion Arm FExperimental Treatment1 Intervention

NGM707 with pembrolizumab in SCCHN

Group VII: NGM707 Combination Dose Expansion Arm EExperimental Treatment1 Intervention

NGM707 with pembrolizumab in NSCLC

0 / 3Eligibility 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

Pembrolizumab, a common treatment for esophageal cancer, inhibits the PD-1 pathway, allowing the immune system to recognize and attack cancer cells. This targeted approach is crucial for enhancing the body's defense against tumors. Investigational treatments like NGM707, though their exact mechanisms are unknown, are likely being studied for their potential to boost immune response or target specific tumor growth pathways. Understanding these mechanisms aids in selecting effective therapies and predicting patient outcomes.