Trial: An Evaluation of NGM120 in a Randomized…

Trial Details

Sponsor: NGM Biopharmaceuticals, Inc (industry)

Phase: 2

Start date: None

Planned enrollment: 136

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Investigational Drug AI Analysis

Show for: NGM120

Overview

NGM120 is an investigational antagonist antibody developed by NGM Biopharmaceuticals, targeting the glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) to inhibit growth differentiation factor 15 (GDF15) signaling. This pathway is implicated in cancer progression and cancer-associated cachexia, a syndrome characterized by severe weight loss and muscle wasting. (news.ngmbio.com)

Mechanism of Action

NGM120 binds to GFRAL, preventing its interaction with GDF15. By inhibiting this signaling pathway, NGM120 aims to mitigate tumor growth and alleviate cachexia symptoms. Elevated serum levels of GDF15 are associated with poor prognosis in various cancers, including pancreatic and prostate cancers. (news.ngmbio.com)

Efficacy

Pancreatic Cancer:

In a Phase 1b dose-escalation study, NGM120 was administered in combination with gemcitabine and nab-paclitaxel to patients with metastatic pancreatic cancer. Preliminary results indicated:

Disease Control Rate: 100% among six evaluable patients at 16 weeks, with three achieving partial responses and three maintaining stable disease.
Progression-Free Survival: Median not reached; as of the data cut-off, the 12-month survival rate was 83.3%.
Duration of Response: Three patients experienced partial responses extending beyond 32 weeks, including one ongoing at 90 weeks. (news.ngmbio.com)

Prostate Cancer:

In a Phase 1a study involving five patients with advanced prostate cancer:

Partial Response: One patient exhibited a partial response ongoing at 62 weeks.
PSA Reduction: Two patients experienced reductions in prostate-specific antigen (PSA) levels, with one achieving undetectable levels.
Disease Control: Two of five patients demonstrated disease control. (news.ngmbio.com)

Safety

NGM120 has been well tolerated in clinical studies:

Pancreatic Cancer Study: No dose-limiting toxicities reported; adverse events were consistent with those expected from gemcitabine and nab-paclitaxel treatment.
Prostate Cancer Study: No dose-limiting toxicities observed; most adverse events were Grade 1 or 2 and not attributed to NGM120. (news.ngmbio.com, news.ngmbio.com)

More Resources

Trial ID: NCT07033026

More trial details at ClinicalTrials.gov

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HealthScout AI Analysis

Goal: The goal of the trial is to evaluate the efficacy, safety, and tolerability of NGM120 in improving body weight and reducing cancer cachexia in participants with colorectal cancer.

Patients: The study enrolls adult patients with a documented active diagnosis of colorectal cancer who also have cancer cachexia, as defined by the Fearon criteria for weight loss. Patients with other reversible causes of decreased food intake, or those already receiving tube feedings or parenteral nutrition, are excluded.

Design: This is a multicenter, randomized, double-blind, placebo-controlled phase 2 clinical trial.

Treatments: Patients are randomized to receive either low or high dose NGM120 administered subcutaneously every 4 or 8 weeks, or matching placebo controls. NGM120 is a monoclonal antibody that antagonizes the GFRAL receptor, thereby inhibiting GDF15 signaling implicated in cancer progression and cachexia. Early phase trials in metastatic pancreatic and advanced prostate cancer have indicated that NGM120 is well tolerated and may demonstrate disease control, with no dose-limiting toxicities reported and mostly mild adverse events. The mechanism of action involves reducing the anorexigenic and cachexia-promoting effects of elevated GDF15 seen in advanced malignancy.

Outcomes: The primary efficacy endpoint is change from baseline in body weight at week 12, while primary safety endpoints include treatment-emergent adverse events monitored over 44 weeks.

Burden on patient: Patient burden is expected to be moderate. The investigational drug is administered subcutaneously every 4 or 8 weeks, which is comparable to routine oncology clinic visits. Although detailed procedures are not described, as a phase 2 study, participants can anticipate regular clinic visits for dosing, safety labs, and adverse event monitoring, but no mention is made of invasive procedures or frequent pharmacokinetic blood sampling. Overall, the burden is similar to typical phase 2 oncology trials evaluating intravenous or subcutaneous agents.

Eligibility

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Sites (1)

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NGM Clinical Study Site

Laredo, Texas, 78041, United States

[email protected] / No phone

Status: Recruiting

A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia