Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 3 years 3 months later Dec 31, 2026 → Apr 20, 2030
See other at-risk trials from SystImmune Inc.

Record History

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  1. Primary completion pushed from Dec 31, 2026 to Apr 20, 2030 Show 4 more changesShow less
    • Enrollment increased: 470 → 540 participants
    • Study completion pushed from Mar 21, 2028 to Jul 22, 2030
    • Study sites: 39 to 37
    • Eligibility criteria expanded, about 23 words
  2. Study sites: 23 to 39v10
  3. Enrollment target: 260 to 470v9 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study sites: 22 to 23
    • Eligibility criteria expanded, about 854 words
    • Secondary endpoints: 17 to 18
  4. Re-verified, no change to tracked fieldsv8
  5. Study sites: 16 to 22
    • Eligibility criteria expanded, about 746 words
    • Study title shortened, about 2 words
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Jul 31, 2024 to Dec 31, 2025
    • Study sites: 10 to 16
    • Study completion date: Sep 30, 2025 to Mar 21, 2028
    • Eligibility criteria expanded, about 183 words
    v6
  2. Enrollment target: 100 to 260v5 Show 4 more changesShow less
    • Study sites: 6 to 10
    • Eligibility criteria shortened, about 9 words
    • Study description expanded, about 4 words
    • Study title expanded, about 4 words
  3. Study sites: 2 to 6v4
  4. Eligibility criteria shortened, about 1,003 wordsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 31, 2023 to Aug 8, 2023
    v2
  1. Study First Submitted
  • 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.
SystImmune Inc.
9 trials monitored
See 1 trial at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,085 trials monitored
See 178 trials at risk
and 8 more diseases
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.
Trial Details
NCT Number NCT05983432
Lead Sponsor SystImmune Inc.
Conditions
(from sponsor)		 Non Small Cell Lung Cancer, Esophageal Cancer, Small Cell Lung Cancer, Nasopharyngeal Cancer, Head and Neck Squamous Cell Carcinoma, Prostate Adenocarcinoma, Ovarian Cancer, Endometrial Cancer +2 more
Related terms Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms, Esophageal Neoplasms, Nasopharyngeal Neoplasms, Ovarian Neoplasms, Small Cell Lung Carcinoma, Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov