Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04429542 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Dec 31, 2026 → Oct 31, 2027
See other at-risk trials from Bicara Therapeutics

Record History

  1. Primary completion pushed from Dec 31, 2026 to Oct 31, 2027 Enrollment increased: 292 → 473 participants · Completion pushed from Jun 1, 2027 to Mar 30, 2028 · Study sites: 20 to 21 · 3 more Show 6 more changesShow less
    • Enrollment increased: 292 → 473 participants
    • Completion pushed from Jun 1, 2027 to Mar 30, 2028
    • Study sites: 20 to 21
    • Eligibility criteria expanded, about 18 words
    • Collaborators: details revised at 1 of 1 entry
    • Publications: details revised at 1 of 1 entry
  2. Study sites: 19 to 20 Eligibility criteria expanded, about 70 wordsv21 Show 1 more changeShow less
    • Eligibility criteria expanded, about 70 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site contacts updated at 16 of 19 sitesv20
  4. Study sites: 17 to 19v19
  5. Study sites: 16 to 17v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 15 to 16v17
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2026 Completion date: Jun 1, 2025 to Jun 1, 2027v16 Show 1 more changeShow less
    • Completion date: Jun 1, 2025 to Jun 1, 2027
  3. Study sites: 14 to 15v15
  4. Study sites: 13 to 14v14
  5. Primary completion date: Dec 31, 2023 to Dec 31, 2024 Study sites: 11 to 13 · Completion date: Jun 1, 2024 to Jun 1, 2025 · Eligibility criteria expanded, about 62 wordsv13 Show 3 more changesShow less
    • Study sites: 11 to 13
    • Completion date: Jun 1, 2024 to Jun 1, 2025
    • Eligibility criteria expanded, about 62 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Dec 31, 2022 to Dec 31, 2023 Study sites: 10 to 11 · Completion date: Jun 1, 2023 to Jun 1, 2024v12 Show 2 more changesShow less
    • Study sites: 10 to 11
    • Completion date: Jun 1, 2023 to Jun 1, 2024
  7. Collaborators expanded, about 5 wordsv11 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 7 to 10v10
  9. Eligibility criteria expanded, about 182 words Study description shortened, about 35 words · Study title shortened, about 1 wordv9 Show 2 more changesShow less
    • Study description shortened, about 35 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  10. Site details revised at 6 of 7 sitesv8
  11. Re-verified, no change to tracked fieldsv7
  12. Study sites: 5 to 7v6
  13. Site details revised at 3 of 5 sitesv5
  14. Site details revised at 1 of 5 sitesv4
  15. Study description shortened, about 52 words Eligibility criteria shortened, about 1 wordv3 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  16. Site details revised at 1 of 5 sitesv2
  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.
Bicara Therapeutics
3 trials monitored
See 1 trial at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 3 more diseases
The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.
Trial Details
NCT Number NCT04429542
Lead Sponsor Bicara Therapeutics
Collaborators: Merck Sharp & Dohme LLC
Conditions Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal, Colorectal Cancer, Squamous Cell Carcinoma of the Lung, EGFR Amplification, Epithelial Ovarian Cancer, Pancreas Cancer, Cutaneous Squamous Cell Carcinoma +3 more
Enrollment 473 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov