Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05608044 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites revised (65)v12
  2. Primary completion date: Feb 2025 to Sep 2027
    • Study completion date: Jul 2025 to Sep 2029
    v11
  3. Enrollment target: estimated 230 to confirmed 234
    • Study sites: 70 to 65
    v10
  4. Primary completion date: Jan 2024 to Feb 2025v9
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 71 to 70
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 63 to 71
    • Eligibility criteria expanded, about 3 words
    v7
  2. Study sites: 60 to 63v6
  3. Study sites: 42 to 60
    • Eligibility criteria expanded, about 21 words
    v5
  4. Site contacts updated at 4 of 42 sitesv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2022 to Nov 30, 2022
    • Site details revised at 42 of 42 sites
    v3
  6. Enrollment target: 120 to 230v2 Show 8 more changesShow less
    • Start date: Nov 2022 to Dec 2022
    • Interventions: Balstilimab (Drug), Botensilimab (Drug) to Balstilimab (Drug), Botensilimab (Drug), Standard of Care (Drug)
    • Eligibility criteria expanded, about 67 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 16 words
    • Site contacts updated at 5 of 42 sites
    • Study arms: 4 to 5
    • Study title shortened, about 3 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.
Trial Details
NCT Number NCT05608044
Lead Sponsor Agenus Inc.
Conditions
(from sponsor)		 Metastatic Colorectal Cancer
Related terms Colorectal Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12, Parkinson Disease 4, Autosomal Dominant Lewy Body
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov