Pancreatic CancerPhase 1NCT05215574
Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
A Phase 1 study testing NGM831, NGM831 plus pembrolizumab (KEYTRUDA®) and NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) in people with Pancreatic Cancer and Breast Cancer, run by NGM Biopharmaceuticals, Inc at 9 sites in United States.
Trial summary
Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Breast Cancer, Gastric Cancer
- What is being tested?
- NGM831, NGM831 plus pembrolizumab (KEYTRUDA®) and NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 9 sitesUnited States
- Study dates
- 31 Mar 2022to Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
- Adequate bone marrow, kidney and liver function
- Performance status of 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.
Who cannot join
- Prior treatment targeting ILT3.
- Prior treatment targeting LAIR1.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
NGM Clinical Study Site
Austin, Texas, 78758
NGM Clinical Study Site
Gilbert, Arizona, 85234
NGM Clinical Study Site
Grand Rapids, Michigan, 49546
NGM Clinical Study Site
Houston, Texas, 77030
NGM Clinical Study Site
Los Angeles, California, 90025
NGM Clinical Study Site
New York, New York, 10016
NGM Clinical Study Site
Oklahoma City, Oklahoma, 73104
NGM Clinical Study Site
Sarasota, Florida, 34232
NGM Clinical Study Site
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Dose Escalation/Dose Finding Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
- Conditions
- Pancreatic Cancer, Breast Cancer, Gastric Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Endocervical Cancer
- Being tested
- NGM831, NGM831 plus pembrolizumab (KEYTRUDA®), NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)
- Medical subject headings
- Pancreatic Neoplasms, Breast Neoplasms, Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM831Drug
Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
NGM831 plus pembrolizumab (KEYTRUDA®)Drug
Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21day cycle. Multiple dose levels will be evaluated.
Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21day cycle.
NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)Drug
Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated.
Drug: NGM438 NGM438 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated.
Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| NGM831 Monotherapy Dose Escalation | Experimental | Part 1a Single Agent Dose Escalation Receives: Drug: NGM831 |
| NGM831 combination dose finding with pembrolizumab (KEYTRUDA®) | Experimental | Part 1b NGM831 plus pembrolizumab (KEYTRUDA®) Receives: Drug: NGM831 plus pembrolizumab (KEYTRUDA®) |
| NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®) | Experimental | Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) Receives: Drug: NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Dose-limiting Toxicities
A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the Investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.
Measured: Baseline up to 21 Days
Incidence of Adverse Events
Number of patients with treatment-emergent adverse events (AEs) An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.
Measured: Baseline up to Approximately 24 months
Secondary outcomes (11)
Maximum Observed Serum Concentration (Cmax) of NGM831
Cmax is defined as the observed maximum serum concentration post drug administration.
Will be measured for Cycle 1 and Cycle 3.
Measured: Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM831
Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration.
Will be measured for Cycle 1 and Cycle 3.
Measured: Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831
AUC is defined as area under the concentration time curve of the dosing interval post drug administration.
Will be calculated for Cycle 1 and Cycle 3.
Measured: Baseline up to approximately 9 weeks
Maximum Observed Serum Concentration (Cmax) of NGM438
Cmax is defined as the observed maximum serum concentration post drug administration.Will be measured for Cycle 1 and Cycle 3.
Measured: Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM438.
Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration.
Will be measured for Cycle 1 and Cycle 3.
Measured: Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438
AUC is defined as area under the concentration time curve of the dosing interval post drug administration.
Will be calculated for Cycle 1 and Cycle 3.
Measured: Baseline up to approximately 9 weeks
Anti-drug Antibodies (ADA) Against NGM831
Incidence and titers of anti-drug antibodies (ADA) against NGM831. Will be measured on Day 1 of each cycle.
Measured: Baseline up to approximately 24 months
Anti-drug Antibodies (ADA) Against NGM438
Incidence and titers of anti-drug antibodies (ADA) against NGM438. Will be measured on Day 1 of each cycle.
Measured: Baseline up to approximately 24 months
Neutralizing antibodies (nAb) against NGM831
Incidence and titers of neutralizing antibodies (nAb) against NGM831. Will be measured on Day 1 of each cycle.
Measured: Baseline up to approximately 24 months
Neutralizing antibodies (nAb) against NGM438
Incidence and titers of neutralizing antibodies (nAb) against NGM438. Will be measured on Day 1 of each cycle.
Measured: Baseline up to approximately 24 months
Number of Patients with Objective Responses
Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) divided by the total number of evaluable patients per RECIST v1.1.
Measured: Baseline up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start31 Mar 2022
- Primary completionJul 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215574
- Sponsor's protocol ID
- 831-IO-101
- Other IDs
- KEYNOTE-E13
- Status last verified
- Oct 2024
- First submitted
- 19 Jan 2022
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation/Dose Finding Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05215574
- Acronym / sponsor ID
- 831-IO-101
- Conditions
- Pancreatic Cancer, Breast Cancer, Gastric Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Endocervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NGM831 Monotherapy Dose Escalation | Experimental | Drug: NGM831Part 1a Single Agent Dose Escalation |
| NGM831 combination dose finding with pembrolizumab (KEYTRUDA®) | Experimental | Drug: NGM831 plus pembrolizumab (KEYTRUDA®)Part 1b NGM831 plus pembrolizumab (KEYTRUDA®) |
| NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®) | Experimental | Drug: NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
- Adequate bone marrow, kidney and liver function
- Performance status of 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.
Key exclusion criteria (2 listed)
- Prior treatment targeting ILT3.
- Prior treatment targeting LAIR1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGM831Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. | Drug | NGM831 Monotherapy Dose Escalation |
| NGM831 plus pembrolizumab (KEYTRUDA®)Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21day cycle. | Drug | NGM831 combination dose finding with pembrolizumab (KEYTRUDA®) |
| NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated. Drug: NGM438 NGM438 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21-day cycle. | Drug | NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®) |
Primary outcome
Number of Patients with Dose-limiting Toxicities
Time frame: Baseline up to 21 Days
A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the Investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.
Incidence of Adverse Events
Time frame: Baseline up to Approximately 24 months
Number of patients with treatment-emergent adverse events (AEs) An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented.
11 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of NGM831
Time frame: Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM831
Time frame: Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831
Time frame: Baseline up to approximately 9 weeks
Maximum Observed Serum Concentration (Cmax) of NGM438
Time frame: Baseline up to approximately 9 weeks
Time to Maximum Observed Serum Concentration (Tmax) of NGM438.
Time frame: Baseline up to approximately 9 weeks
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438
Time frame: Baseline up to approximately 9 weeks
Anti-drug Antibodies (ADA) Against NGM831
Time frame: Baseline up to approximately 24 months
Anti-drug Antibodies (ADA) Against NGM438
Time frame: Baseline up to approximately 24 months
Neutralizing antibodies (nAb) against NGM831
Time frame: Baseline up to approximately 24 months
Neutralizing antibodies (nAb) against NGM438
Time frame: Baseline up to approximately 24 months
Number of Patients with Objective Responses
Time frame: Baseline up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NGM831, NGM831 plus pembrolizumab (KEYTRUDA®) and NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) in people with Pancreatic Cancer and Breast Cancer, run by NGM Biopharmaceuticals, Inc at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Dose-limiting Toxicities (time frame: Baseline up to 21 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.