CRCPhase 2NCT07511972
Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
A Phase 2 study testing NGM707 plus pembrolizumab in people with CRC, run by NGM Biopharmaceuticals, Inc.
Trial summary
Study of NGM707 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
- CRC
- What is being tested?
- NGM707 plus pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2023to 30 Sep 2025
- Phase
- Phase 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.
- Patients must not be amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- Have at least 1 measurable lesion per RECIST v1.1 criteria.
- 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.
About this study
Official title: A Phase 2 Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
- Conditions
- CRC
- Being tested
- NGM707 plus pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM707 plus pembrolizumabDrug
Drug: NGM707
NGM707 will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
Drug: pembrolizumab
Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| NGM707 Combination Cohort A | Experimental | NGM707 with pembrolizumab in MSS CRC Receives: Drug: NGM707 plus pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) as per RECIST v1.1
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start14 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Why it stopped: Study terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, NGM Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511972
- Sponsor's protocol ID
- 707-IO-201
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of NGM707 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT07511972
- Acronym / sponsor ID
- 707-IO-201
- Conditions
- CRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 6 Apr 2026 (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 in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGM707 Combination Cohort A | Experimental | Drug: NGM707 plus pembrolizumabNGM707 with pembrolizumab in MSS CRC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
- Patients must not be amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- Have at least 1 measurable lesion per RECIST v1.1 criteria.
- Adequate bone marrow, kidney and liver function.
- Performance status of 0 or 1.
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 |
|---|---|---|
| NGM707 plus pembrolizumabDrug: NGM707 NGM707 will be administered intravenously (IV) every 3 weeks in a 21 day cycle. Drug: pembrolizumab Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle. | Drug | NGM707 Combination Cohort A |
Primary outcome
Objective response rate (ORR) as per RECIST v1.1
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
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NGM707 plus pembrolizumab in people with CRC, run by NGM Biopharmaceuticals, Inc.
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 6 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: withdrawn, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective response rate (ORR) as per RECIST v1.1 (time frame: Baseline up to approximately 24 months). 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 6 Apr 2026.