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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 weeks
Awards & highlights
PINNACLES Trial Summary
This trial is testing a new drug, NGM120, on patients with advanced solid tumors, pancreatic cancer, and metastatic castration resistant prostate cancer.
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.Check my eligibility
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.See study design
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.
PINNACLES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
PINNACLES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 19 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Number of Patients with Clinically Significant Laboratory Abnormalities
Number of patients with Dose-Limiting Toxicities
Secondary outcome measures
Assessment of Antitumor and Anticachexia Activity Assessed using the RECIST Version 1.1 criteria
Body weight during therapy with NGM120
Immunogenicity against NGM120
+2 morePINNACLES 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 1
~100
Find a Location
Who is running the clinical trial?
NGM Biopharmaceuticals, IncLead Sponsor
23 Previous Clinical Trials
2,146 Total Patients Enrolled
NGM Study DirectorStudy DirectorNGM Biopharmaceuticals, Inc
9 Previous Clinical Trials
1,078 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an inflammatory bowel disease.Your blood test shows GDF15 levels equal to or higher than 1300 pg/mL.You have tested positive for HIV.I have a weakened immune system or have had an organ transplant.I have serious heart or blood vessel problems.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.I do not have any serious infections, significant illnesses, abnormal lab results, or psychiatric/social issues.I agree to follow the study's rules for using birth control and not donate sperm for 90 days after my last treatment.I haven't used strong immune-suppressing drugs in the last 14 days, except for minor exceptions.I have an untreated brain or spinal cord condition.I haven't had chemotherapy, except as a preventive measure after surgery.My pancreatic cancer has spread and is confirmed by tests.You are expected to live for at least 12 weeks.I can provide a tumor sample from the last 5 years or get a new biopsy.My prostate cancer has worsened despite hormone therapy, and I can't or won't have chemotherapy.My testosterone levels are effectively lowered to below 0.5 ng/mL.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: NGM120 Dose 1
- Group 3: NGM120 Dose 5
- Group 4: NGM120 Dose 4
- Group 5: NGM120 Dose 2
- Group 6: NGM120 Dose 3
- Group 7: NGM120 Dose 6
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many different sites is this trial being conducted?
"Presently, this clinical trial is enrolling patients at 17 sites. If you are considering participating in the trial, it would be beneficial to choose a location nearest to you from the list of locations below. The sites are located in Chicago, Aurora and San Diego as well as other cities 17 other locations:"
Answered by AI
If a patient wanted to enroll in this clinical trial, would they still be able to do so?
"This study, which is actively recruiting patients, was originally posted on October 16th 2019. The last update to the study was made on August 29th 2022."
Answered by AI
How many individuals are trialing this medication?
"That is correct, the online clinical trial registry does show that this research is actively looking for participants. This particular study was created on October 16th, 2019 and was edited most recently on August 29th, 2020. They are hoping to recruit 75 individuals total from 17 different locations."
Answered by AI
What patient outcomes does this research aim to improve?
"The purpose of this 19-week clinical trial is to evaluate the efficacy of NGM120 in terms of the number of patients with clinically significant laboratory abnormalities. Other secondary outcomes include assessment of tumor and cachexia activity using RECIST Version 1.1 criteria, immunogenicity against NGM120, and pharmacokinetics of NGM120."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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