Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors

NCT05215574
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
130
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Lead sponsor
NGM Biopharmaceuticals, Inc
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Start date
2022-03-31
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Number of sites
9
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Summary
Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
clinicaltrials.gov
Short title
Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-03-01
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First posted
2022-01-31
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Registry last updated
2024-10-10
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Primary completion date
2025-07-01
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Start date
2022-03-31
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Participants
130
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Participant count basis
Estimated
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Planned participants
130
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Protocol amendments
3
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Number of sites
9
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
NGM Biopharmaceuticals, Inc
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05215574
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ClinicalTrials.gov ID
NCT05215574
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Patients with Dose-limiting Toxicities

    Timeframe: 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.

  2. Incidence of Adverse Events

    Timeframe: 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.

  1. Maximum Observed Serum Concentration (Cmax) of NGM831

    Timeframe: Baseline up to approximately 9 weeks

    Cmax is defined as the observed maximum serum concentration post drug administration. Will be measured for Cycle 1 and Cycle 3.

  2. Time to Maximum Observed Serum Concentration (Tmax) of NGM831

    Timeframe: Baseline up to approximately 9 weeks

    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.

  3. Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831

    Timeframe: Baseline up to approximately 9 weeks

    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.

  4. Maximum Observed Serum Concentration (Cmax) of NGM438

    Timeframe: Baseline up to approximately 9 weeks

    Cmax is defined as the observed maximum serum concentration post drug administration.Will be measured for Cycle 1 and Cycle 3.

  5. Time to Maximum Observed Serum Concentration (Tmax) of NGM438.

    Timeframe: Baseline up to approximately 9 weeks

    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.

  6. Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438

    Timeframe: Baseline up to approximately 9 weeks

    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.

  7. Anti-drug Antibodies (ADA) Against NGM831

    Timeframe: Baseline up to approximately 24 months

    Incidence and titers of anti-drug antibodies (ADA) against NGM831. Will be measured on Day 1 of each cycle.

  8. Anti-drug Antibodies (ADA) Against NGM438

    Timeframe: Baseline up to approximately 24 months

    Incidence and titers of anti-drug antibodies (ADA) against NGM438. Will be measured on Day 1 of each cycle.

  9. Neutralizing antibodies (nAb) against NGM831

    Timeframe: Baseline up to approximately 24 months

    Incidence and titers of neutralizing antibodies (nAb) against NGM831. Will be measured on Day 1 of each cycle.

  10. Neutralizing antibodies (nAb) against NGM438

    Timeframe: Baseline up to approximately 24 months

    Incidence and titers of neutralizing antibodies (nAb) against NGM438. Will be measured on Day 1 of each cycle.

  11. Number of Patients with Objective Responses

    Timeframe: 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) divided by the total number of evaluable patients per RECIST v1.1.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • Prior treatment targeting ILT3.
  • Prior treatment targeting LAIR1.
Sources for eligibility
clinicaltrials.gov

  • NGM Clinical Study SiteGilbert, United States
  • NGM Clinical Study SiteLos Angeles, United States
  • NGM Clinical Study SiteSarasota, United States
  • NGM Clinical Study SiteTampa, United States
  • NGM Clinical Study SiteGrand Rapids, United States
  • NGM Clinical Study SiteNew York, United States
  • NGM Clinical Study SiteOklahoma City, United States
  • NGM Clinical Study SiteAustin, United States
  • NGM Clinical Study SiteHouston, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • KEYNOTE-E13
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (21)

Targets (1)