Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03860272 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv35
  2. Trial status: Recruiting to Active, Not Recruitingv34 Show 5 more changesShow less
    • Enrollment target: estimated 550 to confirmed 499
    • Study sites: 19 to 18
    • Primary completion date changed from estimate of Dec 2026 to Jan 13, 2025
    • Study completion date: Dec 2026 to Dec 2027
    • Start date: Apr 1, 2019 to Mar 20, 2019
  3. Site details revised at 1 of 19 sitesv33
  4. Primary and study completion dates: Dec 2024 to Dec 2026v32 Show 4 more changesShow less
    • Enrollment target: 450 to 550
    • Study sites: 15 to 19
    • Eligibility criteria expanded, about 46 words
    • Study description shortened, about 2 words
  5. Enrollment target: 195 to 450v31 Show 4 more changesShow less
    • Eligibility criteria expanded, about 753 words
    • Secondary endpoints: 14 to 18
    • Site contacts updated at 5 of 15 sites
    • Study description expanded, about 2 words
Show 29 earlier versionsHide 29 earlier versions
  1. Eligibility criteria expanded, about 5 wordsv30
  2. Site contacts updated at 1 of 15 sitesv29
  3. Site contacts updated at 1 of 15 sitesv28
  4. Site contacts updated at 2 of 15 sites
    • Study description shortened, about 4 words
    v27
  5. Enrollment target: 125 to 195v26 Show 4 more changesShow less
    • Primary and study completion dates: Dec 2023 to Dec 2024
    • Eligibility criteria expanded, about 26 words
    • Study description expanded, about 30 words
    • Study sites revised (15)
  6. Site details revised at 4 of 15 sitesv25
  7. Phase: Phase 1/2 to Phase 1v24 Show 7 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 86 to 125
    • Study sites: 12 to 15
    • Interventions: AGEN1181 (Drug), AGEN1181 (Drug), AGEN2034 (Drug) to Balstilimab (Drug), Botensilimab (Drug)
    • Eligibility criteria shortened, about 43 words
    • Secondary endpoints revised (14)
    • Study description shortened, about 77 words
  8. Site contacts updated at 7 of 12 sitesv23
  9. Study sites: 10 to 12v22
  10. Site details revised at 1 of 10 sitesv21
  11. Study sites: 9 to 10v20
  12. Site details revised at 2 of 9 sitesv19
  13. Site contacts updated at 3 of 9 sitesv18
  14. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 9 of 9 sites
    v17
  15. Phase: Phase 1 to Phase 1/2
    • Trial status: Recruiting to Active, Not Recruiting
    • Study description revised
    • Site details revised at 9 of 9 sites
    v16
  16. Site contacts updated at 1 of 9 sitesv15
  17. Site contacts updated at 1 of 9 sitesv14
  18. Study sites: 8 to 9v13
  19. Re-verified, no change to tracked fieldsv12
  20. Primary completion date: Dec 2022 to Dec 2023
    • Study sites: 5 to 8
    • Eligibility criteria expanded, about 43 words
    • Study description expanded, about 67 words
    v11
  21. 2 versions Re-verified since Apr 24, 2020, no change to tracked fieldsv9-v10
  22. Site contacts updated at 1 of 5 sitesv8
  23. Enrollment target: 36 to 86v7 Show 9 more changesShow less
    • Primary completion date: Mar 2022 to Dec 2022
    • Primary endpoints revised (3)
    • Study completion date: Mar 2022 to Dec 2023
    • Start date: Mar 20, 2019 to Apr 1, 2019
    • Interventions: AGEN1181 (Drug) to AGEN1181 (Drug), AGEN1181 (Drug), AGEN2034 (Drug)
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: 15 to 14
    • Study description shortened, about 30 words
    • Study arms: 1 to 3
  24. Site details revised at 1 of 5 sitesv6
  25. Eligibility criteria expanded, about 52 words
    • Secondary endpoints: 16 to 15
    • Site contacts updated at 4 of 5 sites
    • Study description shortened, about 2 words
    v5
  26. Site details revised at 1 of 5 sitesv4
  27. Site details revised at 4 of 5 sitesv3
  28. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2019 to Mar 20, 2019
    • Site details revised at 5 of 5 sites
    v2
  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.
Agenus Inc.
6 trials monitored
See all monitored trials
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
and 4 more diseases
This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Trial Details
NCT Number NCT03860272
Lead Sponsor Agenus Inc.
Conditions
(from sponsor)		 Advanced Cancer, Angiosarcoma, Colorectal Cancer Without Liver Metastases, Endometrial Cancer, Fibrolamellar Carcinoma, Non-small-cell Lung Cancer, Ovarian Cancer, Prostate Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms, Fibrolamellar hepatocellular carcinoma, Hemangiosarcoma, Ovarian Neoplasms, Prostatic Neoplasms
Enrollment 499 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov