What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer primarily include chemotherapy regimens such as FOLFIRINOX and gemcitabine plus nab-paclitaxel. FOLFIRINOX combines multiple agents to inhibit DNA replication and repair, thereby killing rapidly dividing cancer cells. Gemcitabine, a nucleoside analog, interferes with DNA synthesis, while nab-paclitaxel disrupts microtubule function, preventing cell division. These treatments aim to reduce tumor size and slow disease progression. Investigational treatments like NGM120, a monoclonal antibody targeting the GDF15 pathway, are being studied for their potential to inhibit tumor growth and metastasis by blocking signals that promote cancer cell survival and immune evasion. Understanding these mechanisms is crucial for pancreatic cancer patients as it helps tailor therapies to target specific pathways involved in their cancer, potentially improving outcomes and reducing side effects.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like gemcitabine and nab-paclitaxel can cause side effects such as nausea, vomiting, fatigue, and myelosuppression. Targeted therapies, including tyrosine kinase inhibitors, may lead to diarrhea, hypertension, and liver toxicity. Immunotherapy and monoclonal antibodies, such as those targeting PD-1/PD-L1, can result in immune-related adverse events like colitis, dermatitis, and pneumonitis. Specific to monoclonal antibodies similar to NGM120, side effects may include infusion reactions, fatigue, and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapeutic agents like gemcitabine and nab-paclitaxel, as well as targeted therapies. For instance, pembrolizumab, a monoclonal antibody targeting PD-1, is approved for tumors with specific genetic markers such as dMMR/MSI-H. While the context does not provide specific information on monoclonal antibodies targeting the GDF15 pathway like NGM120, it highlights the ongoing exploration of targeted therapies and immunotherapies in pancreatic cancer treatment.

What other types of research exist?

Promising novel alternatives to NGM120 for pancreatic cancer patients include: 1) TRX518, a GITR agonist antibody, which has shown efficacy in combination with gemcitabine, pembrolizumab, or nivolumab in advanced solid tumors. 2) GNE-477, a PI3K/mTOR inhibitor, which has demonstrated significant antitumor effects in glioblastoma and could be explored for pancreatic cancer. 3) Combination therapies involving EZH2 and EGFR inhibitors, such as Gefitinib and GSK126, which have shown synergistic effects in increasing cell apoptosis and autophagy in cancer cells.

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Monoclonal Antibodies

NGM120 for Pancreatic and Prostate Cancer (PINNACLES Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by NGM Biopharmaceuticals, Inc

Eligibility Criteria Checklist

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

Must have

Have not received any approved chemotherapy, except in the adjuvant setting.

Effective castration with serum testosterone levels <0.5 ng/mL (50 ng/dL; 1.7 nmol/L).

Must not have

Subject has a history or presence of documented inflammatory bowel disease.

Subject has documented immunodeficiency or organ transplant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 19 weeks

Summary

This trial is testing NGM120, a new drug, in patients with advanced solid tumors, pancreatic cancer, and metastatic prostate cancer. The drug works by blocking signals that help cancer cells grow.

Who is the study for?

This trial is for adults with certain advanced solid tumors or metastatic cancers, including prostate and pancreatic cancer. Participants must have a life expectancy of at least 12 weeks, agree to use contraception, and not have received prior chemotherapy (except as adjuvant therapy). They need an archival tumor sample or be willing to provide a biopsy if none exists.

What is being tested?

The study tests NGM120 against a placebo in patients with various advanced cancers. It's divided into parts: the first two focus on solid tumors and pancreatic cancer; the third targets metastatic castration-resistant prostate cancer.

What are the potential side effects?

While specific side effects of NGM120 are not listed here, common ones for cancer treatments include fatigue, nausea, increased risk of infection, allergic reactions, organ inflammation, blood disorders and potential impacts on heart rhythm.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had chemotherapy, except as a preventive measure after surgery.

Select...

My testosterone levels are effectively lowered to below 0.5 ng/mL.

Exclusion Criteria

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

Select...

I have been diagnosed with an inflammatory bowel disease.

Select...

I have a weakened immune system or have had an organ transplant.

Select...

I have serious heart or blood vessel problems.

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I have an untreated brain or spinal cord condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 19 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~19 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Adverse Events

Number of Patients with Clinically Significant Laboratory Abnormalities

Number of patients with Dose-Limiting Toxicities

Secondary study objectives

Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria

Body weight during therapy with NGM120

Immunogenicity against NGM120

+2 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: NGM120 Dose 6Experimental Treatment1 Intervention

NGM120 Subcutaneous Injection

Group II: NGM120 Dose 5Experimental Treatment1 Intervention

NGM120 Subcutaneous Injection

Group III: NGM120 Dose 4Experimental Treatment1 Intervention

NGM120 Subcutaneous Injection

Group IV: NGM120 Dose 3Experimental Treatment1 Intervention

NGM120 Subcutaneous Injection

Group V: NGM120 Dose 2Experimental Treatment1 Intervention

NGM120 Subcutaneous Injection

Group VI: NGM120 Dose 1Experimental Treatment1 Intervention

NGM120 Subcutaneous Injection

Group VII: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NGM120

2018

Completed Phase 2

~190

0 / 6Eligibility 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 pancreatic cancer primarily include chemotherapy regimens such as FOLFIRINOX and gemcitabine plus nab-paclitaxel. FOLFIRINOX combines multiple agents to inhibit DNA replication and repair, thereby killing rapidly dividing cancer cells. Gemcitabine, a nucleoside analog, interferes with DNA synthesis, while nab-paclitaxel disrupts microtubule function, preventing cell division. These treatments aim to reduce tumor size and slow disease progression. Investigational treatments like NGM120, a monoclonal antibody targeting the GDF15 pathway, are being studied for their potential to inhibit tumor growth and metastasis by blocking signals that promote cancer cell survival and immune evasion. Understanding these mechanisms is crucial for pancreatic cancer patients as it helps tailor therapies to target specific pathways involved in their cancer, potentially improving outcomes and reducing side effects.