MesotheliomaPhase 1/2NCT04913337
Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
A Phase 1/2 study testing NGM707 and NGM707 plus pembrolizumab (KEYTRUDA®) in people with Mesothelioma and Glioblastoma, run by NGM Biopharmaceuticals, Inc at 27 sites in 3 countries.
Trial summary
Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Glioblastoma, Renal Cell Carcinoma
- What is being tested?
- NGM707 and NGM707 plus pembrolizumab (KEYTRUDA®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 9 Jun 2021to Jul 2025
- Phase
- Phase 1/2
- 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.
- Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type, and for which the patient was eligible and willing to receive, or refused SOC treatments that are perceived to have marginal clinical benefit.
- 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 ILT2 and/or ILT4 or targeting HLA-G.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
United States20 sites
NGM Clinical Study Site
Albany, New York, 12206
NGM Clinical Study Site
Baltimore, Maryland, 21201
NGM Clinical Study Site
Blacksburg, Virginia, 24060
NGM Clinical Study Site
Boston, Massachusetts, 02215
NGM Clinical Study Site
Dallas, Texas, 75246
NGM Clinical Study Site
Dallas, Texas, 78701
NGM Clinical Study Site
Grand Rapids, Michigan, 49546
NGM Clinical Study Site
Greenville, South Carolina, 29605
NGM Clinical Study Site
Houston, Texas, 77030
NGM Clinical Study Site
Lone Tree, Colorado, 80124
NGM Clinical Study Site
Los Angeles, California, 90033
NGM Clinical Study Site
Newport Beach, California, 92663
NGM Clinical Study Site
Omaha, Nebraska, 68130
NGM Clinical Study Site
San Antonio, Texas, 78229
NGM Clinical Study Site
San Antonio, Texas, 78240
NGM Clinical Study Site
Santa Monica, California, 90404
NGM Clinical Study Site
Santa Rosa, California, 94505
NGM Clinical Study Site
Sarasota, Florida, 34232
NGM Clinical Study Site
Vancouver, Washington, 98684
NGM Clinical Study Site
Washington D.C., District of Columbia, 20007
Taiwan4 sites
NGM Clinical Study Site
New Taipei City, 235
NGM Clinical Study Site
Taichung, 404327
NGM Clinical Study Site
Tainan, 704
NGM Clinical Study Site
Taipei, 100225
South Korea3 sites
NGM Clinical Study Site
Seoul, 03080
NGM Clinical Study Site
Seoul, 05505
NGM Clinical Study Site
Seoul, 06351
About this study
Official title: A Phase 1/2 Dose Escalation/Expansion Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
- Conditions
- Mesothelioma, Glioblastoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Pancreatic Ductal Adenocarcinoma
- Being tested
- NGM707, NGM707 plus pembrolizumab (KEYTRUDA®)
- Medical subject headings
- Mesothelioma, Glioblastoma, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Melanoma, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM707Drug
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
NGM707 plus pembrolizumab (KEYTRUDA®)Drug
Drug: NGM707
NGM707 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.
NGM707 plus pembrolizumab (KEYTRUDA®)Drug
Drug: NGM707
NGM707 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.
NGM707 plus pembrolizumab (KEYTRUDA®)Drug
Drug: NGM707
NGM707 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.
NGM707 plus pembrolizumab (KEYTRUDA®)Drug
Drug: NGM707
NGM707 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.
NGM707Drug
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
NGM707Drug
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
NGM707Drug
Drug: NGM707
NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| NGM707 Monotherapy Dose Escalation | Experimental | Part 1a Single Agent Dose Escalation Receives: Drug: NGM707 |
| NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®) | Experimental | Part 1b NGM707 plus pembrolizumab (KEYTRUDA®) Receives: Drug: NGM707 plus pembrolizumab (KEYTRUDA®) |
| NGM707 Combination Dose Expansion Arm A | Experimental | NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC Receives: Drug: NGM707 plus pembrolizumab (KEYTRUDA®) |
| NGM707 Combination Dose Expansion Arm B | Experimental | NGM707 with pembrolizumab (KEYTRUDA®) in Non-Squamous NSCLC Receives: Drug: NGM707 plus pembrolizumab (KEYTRUDA®) |
| NGM707 Combination Dose Expansion Arm C | Experimental | NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN Receives: Drug: NGM707 plus pembrolizumab (KEYTRUDA®) |
| NGM707 Monotherapy Dose Expansion Arm D | Experimental | NGM707 in RCC Receives: Drug: NGM707 |
| NGM707 Monotherapy Dose Expansion Arm E | Experimental | NGM707 in CRC Receives: Drug: NGM707 |
| NGM707 Monotherapy Dose Expansion Arm F | Experimental | NGM707 in Ovarian Receives: Drug: NGM707 |
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 28 days after the first dose of study treatment.
Measured: Baseline up to 28 Days
Incidence of Adverse Events
Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug
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
Number of Patients with Clinically Significant Laboratory Abnormalities
Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.
Measured: Baseline up to Approximately 24 Months
Number of Patients in Expansion Cohorts with Objective Responses
Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Measured: Baseline up to approximately 24 months
Duration of Response for Patients in Expansion Cohorts
Duration of Response is defined as the time from the first documentation of objective response (CR or PR) that is subsequently confirmed per RECIST v1.1, to the time of the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Measured: Baseline up to approximately 24 months
Progression-free Survival for Patients in Expansion Cohorts
Progression-free survival is defined as the time from start of study treatment to the date of first documentation of objective tumor progression on or following study therapy per RECIST v1.1, or to death due to any cause, whichever comes first.
Measured: Baseline up to approximately 24 months
Overall Survival for Patients in Combination Dose Expansion Cohorts
Overall survival is defined as the date from start of the study treatment to the date of death due to any cause.
Measured: Up to approximately 48 months
Secondary outcomes (4)
Observed Plasma Concentration of NGM707 (Including Cmax)
Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.
Measured: Baseline up to approximately 24 months
Area Under the Curve (AUC) of Plasma NGM707
Area under the curve from time zero extrapolated to the last quantifiable dose of NGM707. Time zero extrapolated to the last quantifiable time point prior to the next dose. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.
Measured: Baseline up to approximately 24 months
Plasma Half-life (t1/2) of NGM707
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter.
Measured: Baseline up to approximately 24 months
Anti-drug Antibodies (ADA) Against NGM707
Incidence and titers of anti-drug antibodies (ADA) against NGM707. Will be measured on Day 1 of each cycle.
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 posted4 Jun 2021
- Study start9 Jun 2021
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, NGM Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913337
- Sponsor's protocol ID
- 707-IO-101
- Other IDs
- KEYNOTE-D25, MK-3475-D25
- Status last verified
- Jun 2024
- First submitted
- 20 May 2021
- Last updated
- 2 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose Escalation/Expansion Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT04913337
- Acronym / sponsor ID
- 707-IO-101
- Conditions
- Mesothelioma, Glioblastoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Jun 2021 (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 NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| NGM707 Monotherapy Dose Escalation | Experimental | Drug: NGM707Part 1a Single Agent Dose Escalation |
| NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®) | Experimental | Drug: NGM707 plus pembrolizumab (KEYTRUDA®)Part 1b NGM707 plus pembrolizumab (KEYTRUDA®) |
| NGM707 Combination Dose Expansion Arm A | Experimental | Drug: NGM707 plus pembrolizumab (KEYTRUDA®)NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC |
| NGM707 Combination Dose Expansion Arm B | Experimental | Drug: NGM707 plus pembrolizumab (KEYTRUDA®)NGM707 with pembrolizumab (KEYTRUDA®) in Non-Squamous NSCLC |
| NGM707 Combination Dose Expansion Arm C | Experimental | Drug: NGM707 plus pembrolizumab (KEYTRUDA®)NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN |
| NGM707 Monotherapy Dose Expansion Arm D | Experimental | Drug: NGM707NGM707 in RCC |
| NGM707 Monotherapy Dose Expansion Arm E | Experimental | Drug: NGM707NGM707 in CRC |
| NGM707 Monotherapy Dose Expansion Arm F | Experimental | Drug: NGM707NGM707 in Ovarian |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
- Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type, and for which the patient was eligible and willing to receive, or refused SOC treatments that are perceived to have marginal clinical benefit.
- 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 (1 listed)
- Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.
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 |
|---|---|---|
| NGM707Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. | Drug | NGM707 Monotherapy Dose Escalation |
| NGM707 plus pembrolizumab (KEYTRUDA®)Drug: NGM707 NGM707 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 | NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®) |
| NGM707 plus pembrolizumab (KEYTRUDA®)Drug: NGM707 NGM707 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 | NGM707 Combination Dose Expansion Arm A |
| NGM707 plus pembrolizumab (KEYTRUDA®)Drug: NGM707 NGM707 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 | NGM707 Combination Dose Expansion Arm B |
| NGM707 plus pembrolizumab (KEYTRUDA®)Drug: NGM707 NGM707 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 | NGM707 Combination Dose Expansion Arm C |
| NGM707Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. | Drug | NGM707 Monotherapy Dose Expansion Arm D |
| NGM707Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. | Drug | NGM707 Monotherapy Dose Expansion Arm E |
| NGM707Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. | Drug | NGM707 Monotherapy Dose Expansion Arm F |
Primary outcome
Number of Patients with Dose-limiting Toxicities
Time frame: Baseline up to 28 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 28 days after the first dose of study treatment.
Incidence of Adverse Events
Time frame: Baseline up to Approximately 24 Months
Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug 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.
Number of Patients with Clinically Significant Laboratory Abnormalities
Time frame: Baseline up to Approximately 24 Months
Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing.
Number of Patients in Expansion Cohorts with Objective Responses
Time frame: Baseline up to approximately 24 months
Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Duration of Response for Patients in Expansion Cohorts
Time frame: Baseline up to approximately 24 months
Duration of Response is defined as the time from the first documentation of objective response (CR or PR) that is subsequently confirmed per RECIST v1.1, to the time of the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Progression-free Survival for Patients in Expansion Cohorts
Time frame: Baseline up to approximately 24 months
Progression-free survival is defined as the time from start of study treatment to the date of first documentation of objective tumor progression on or following study therapy per RECIST v1.1, or to death due to any cause, whichever comes first.
Overall Survival for Patients in Combination Dose Expansion Cohorts
Time frame: Up to approximately 48 months
Overall survival is defined as the date from start of the study treatment to the date of death due to any cause.
4 secondary outcomes
Observed Plasma Concentration of NGM707 (Including Cmax)
Time frame: Baseline up to approximately 24 months
Area Under the Curve (AUC) of Plasma NGM707
Time frame: Baseline up to approximately 24 months
Plasma Half-life (t1/2) of NGM707
Time frame: Baseline up to approximately 24 months
Anti-drug Antibodies (ADA) Against NGM707
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 2 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.
Chief Medical Officer study director
NGM Biopharmaceuticals, Inc
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NGM707 and NGM707 plus pembrolizumab (KEYTRUDA®) in people with Mesothelioma and Glioblastoma, run by NGM Biopharmaceuticals, Inc at 27 sites in 3 countries.
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 5 inclusion and 1 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 2 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 27 sites in United States, Taiwan, South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Days). The study lists 7 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 2 Oct 2024.