Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors

StatusTerminated
PhasePhase 1
Started

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Record History

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  1. Trial terminated Sponsor's reason: The decision is based only on the Sponsor's internal portfolio prioritization and resource management considerations and is not due to the investigational product's toxicity considerations.
    • Final enrollment: 3 participants — 3% of the 120 planned
    • Primary completion date changed from estimate of Sep 1, 2027 to Jan 30, 2026
    • Eligibility criteria expanded, about 16 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 12 to 9
    v5
  3. Site details revised at 1 of 12 sitesv4
  4. Study title shortened, about 1 wordv3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 12
    • Start date changed from estimate of Mar 1, 2025 to Apr 10, 2025
    • Eligibility criteria expanded, about 417 words
    • Study title shortened, about 15 words
    • Study description expanded, about 3 words
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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 5 more diseases
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
Trial Details
NCT Number NCT06714617
Lead Sponsor SystImmune Inc.
Conditions
(from sponsor)		 Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive, HER2 Gene Mutation, Gastroesophageal-junction Cancer, Non Small Cell Lung Cancer, Endometrial Neoplasms +6 more
Related terms Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Stomach Neoplasms
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov