NGM120 for Pancreatic and Prostate Cancer
(PINNACLES Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: NGM Biopharmaceuticals, Inc

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Your blood test shows GDF15 levels equal to or higher than 1300 pg/mL.

Your PSA level has been increasing slowly, taking more than 3 months to double.

I have advanced prostate cancer that has spread and doesn't respond to hormone therapy.

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Exclusion Criteria

I have been diagnosed with an inflammatory bowel disease.

You have tested positive for HIV.

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

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Treatment Details

Interventions

NGM120 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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