NGM120 for Pancreatic and Prostate Cancer

(PINNACLES Trial)

Recruiting at 20 trial locations

Overseen By NGM Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: NGM Biopharmaceuticals, Inc

Must be taking: Medical castration

Must not be taking: Immunosuppressives

Disqualifiers: Active infections, Cardiovascular diseases, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

89 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use immunosuppressive medications within 14 days before screening, except for certain exceptions like low-dose prednisone or medications for hypersensitivity reactions.

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.

Research Team

NGM Study Director

Principal Investigator

NGM Biopharmaceuticals, Inc

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NGM120 or placebo subcutaneous injections to assess dose-limiting toxicities and other outcomes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of antitumor and anticachexia activity

7 weeks

Treatment Details

Interventions

• NGM120

Trial Overview 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.

Participant Groups

Group I: Part 3 NGM120 100mg Q3W Experimental Treatment 1 Intervention

NGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks

Group II: Part 2 NGM120 30mg Experimental Treatment 1 Intervention

NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).

Group III: Part 2 NGM120 100mg Experimental Treatment 1 Intervention

NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).

Group IV: Part 1 NGM120 30mg Experimental Treatment 1 Intervention

NGM120 30mg Subcutaneous Injection

Group V: Part 1 NGM120 100mg Experimental Treatment 1 Intervention

NGM120 100mg Subcutaneous Injection

Group VI: Part 2 Placebo Placebo Group 1 Intervention

Placebo together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).

Who Is Running the Clinical Trial?

NGM Biopharmaceuticals, Inc

Lead Sponsor

Trials

25

Recruited

2,500+