NGM120 for Pancreatic and Prostate Cancer

(PINNACLES Trial)

No longer recruiting at 21 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NGM120 for individuals with certain advanced cancers. It focuses on pancreatic cancer that has spread or returned and prostate cancer resistant to hormonal therapy. The trial aims to assess the effectiveness and safety of NGM120 at various doses. Individuals with pancreatic cancer not yet treated with chemotherapy or prostate cancer that has progressed despite hormone treatments may be suitable candidates for the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NGM120 is generally safe for humans. In earlier studies with healthy volunteers, doses ranging from 10 to 400 mg did not cause serious side effects. In studies involving patients with advanced pancreatic cancer, NGM120 did not produce side effects that prevented doctors from increasing the dose. Most side effects resulted from other cancer drugs used alongside NGM120, such as gemcitabine and nab-paclitaxel, rather than from NGM120 itself. Overall, evidence suggests that NGM120 is safe and well-tolerated in both healthy volunteers and cancer patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about NGM120 for pancreatic and prostate cancer because it introduces a novel approach to treatment. Unlike traditional therapies that primarily focus on directly killing cancer cells, NGM120 targets GDF15, a protein involved in cancer metabolism and cachexia (a wasting syndrome associated with cancer). This unique mechanism could potentially improve not just tumor control but also the quality of life for patients by addressing the debilitating weight loss often seen in cancer patients. Additionally, NGM120 is administered subcutaneously, which might offer a more convenient and less invasive option compared to intravenous treatments. These features position NGM120 as a promising new player in the fight against cancer.

What evidence suggests that NGM120 could be an effective treatment for pancreatic and prostate cancer?

Research has shown that NGM120 may help treat advanced pancreatic and prostate cancers. In this trial, participants will receive varying dosages of NGM120, either alone or with the drugs gemcitabine and Abraxane, for advanced pancreatic cancer. A recent study using NGM120 with gemcitabine and Abraxane showed promising results, with 50% of patients experiencing significant tumor shrinkage. Additionally, NGM120 was well tolerated, as patients did not experience severe side effects. These early findings suggest that NGM120 could be an effective treatment option for these difficult-to-treat cancers. ^{2 3 4 6 7}

Who Is on the Research Team?

NGM Study Director

Principal Investigator

NGM Biopharmaceuticals, Inc

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. news.ngmbio.com news.ngmbio.com/news-releases/news-release-details/ngm-bio-presents-updated-preliminary-findings-subgroup-patients

NGM Bio Presents Updated Preliminary Findings for a ... These results demonstrate that treatment with NGM120 was well tolerated to date in the study with no dose-limiting toxicities and provide encouraging signals ...

2. aacrjournals.org aacrjournals.org/cancerres/article/82/22_Supplement/PR006/710432/Abstract-PR006-Initial-results-of-a-cohort-of

Initial results of a cohort of advanced pancreatic cancer ... Conclusions: NGM120 given in combination with Gem/nab-paclitaxel to patients with APC resulted in a 50% ORR (3 PR in 6 evaluable patients), 100% ...

3. npcf.us npcf.us/clinical-trials/study-of-ngm120-in-subjects-with-advanced-solid-tumors-pancreatic-cancer-and-prostate-cancer-using-combination-therapy/

Study Of NGM120 In Subjects With Advanced Solid Tumors ... The aim of the study is to evaluate the safety and tolerability of NGM120 monotherapy in subjects with select advanced solid tumors (Part 1), NGM120 in ...

4. ctv.veeva.com ctv.veeva.com/study/study-of-ngm120-in-subjects-with-advanced-solid-tumors-pancreatic-cancer-and-prostate-cancer-using

Study of NGM120 in Subjects With Advanced Solid Tumors ... The aim of the study is to evaluate the safety and tolerability of NGM120 monotherapy in subjects with select advanced solid tumors (Part 1), ...

5. ngmbio.com ngmbio.com/wp-content/uploads/2022/09/AACR-Pancreatic-cancer-talk_Final.pdf

Advanced Pancreatic Cancer Initial Results of a Cohort of Advanced Pancreatic Cancer Patients in a Phase 1b Study of NGM120, a First-in-class Anti-GDNF Family.

6. ngmbio.com ngmbio.com/wp-content/uploads/2021/12/ePoster-550P_2021ESMO_Final-1.pdf

Phase 1a – Monotherapy in Advanced Solid Tumors ... In a healthy volunteer study, NGM120 (10-400 mg) was well tolerated with a favorable safety profile. We present the data from Ph1a/1b dose finding study ( ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(21)03301-9/fulltext

550P Initial results of a phase Ia/Ib study of NGM120, a first ... We present the data from Ph1a/1b dose finding study (NCT04068896) of NGM120 and NGM120 + gemcitabine (Gem)/nab-paclitaxel (nab-P) in advanced cancer pts.