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NCT05215574

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

StatusUnknown
PhasePhase 1
Primary completion (estimated)
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Record History

All 14 versions: 13 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2024); last known: Active, Not Recruiting
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v14
  3. Enrollment target: 79 to 130v13 Show 9 more changesShow less
    • Primary completion date: Feb 2024 to Jul 2025
    • Primary endpoints: 3 to 2
    • Eligibility criteria expanded, about 4 words
    • Study completion date: Dec 2024 to Mar 2026
    • Interventions: NGM831 (Drug), NGM831 (Drug), NGM831 plus pembrolizumab (Drug) to NGM831 (Drug), NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) (Drug), NGM831 plus pembrolizumab (KEYTRUDA®) (Drug)
    • Secondary endpoints: 10 to 11
    • Site details revised at 2 of 9 sites
    • Study arms: 6 to 3
    • Study title expanded, about 4 words
  4. Eligibility criteria shortened, about 42 wordsv12 Show 4 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 8 to 9
    • Secondary endpoints: 9 to 10
    • Study arms: 3 to 6
  5. Study sites: 7 to 8v11
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 6 to 7v10
  2. Study sites: 5 to 6v9
  3. Study sites: 4 to 5v8
  4. Study sites: 3 to 4v6
  5. Collaborators expanded, about 5 wordsv5
  6. Site details revised at 1 of 3 sitesv4
  7. Start date changed from estimate of Feb 2022 to Mar 31, 2022v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Patients with Dose-limiting Toxicities
Timeframe: Baseline up to 21 Days
Incidence of Adverse Events
Timeframe: Baseline up to Approximately 24 months

Secondary (11)

Maximum Observed Serum Concentration (Cmax) of NGM831
Time to Maximum Observed Serum Concentration (Tmax) of NGM831
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831
Maximum Observed Serum Concentration (Cmax) of NGM438
Time to Maximum Observed Serum Concentration (Tmax) of NGM438.
Show 6 moreShow less
Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438
Anti-drug Antibodies (ADA) Against NGM831
Anti-drug Antibodies (ADA) Against NGM438
Neutralizing antibodies (nAb) against NGM831
Neutralizing antibodies (nAb) against NGM438
Number of Patients with Objective Responses

Arms and interventions

NGM831 Monotherapy Dose EscalationExperimental

Part 1a Single Agent Dose Escalation

NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)Experimental

Part 1b NGM831 plus pembrolizumab (KEYTRUDA®)

NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®)Experimental

Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

Drugs: NGM831, NGM831 plus pembrolizumab (KEYTRUDA®), NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

Sites

9 sites in 1 country