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NCT06714617 · ClinicalTrials.gov record · last posted 2025-11-04

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

StatusActive, Not Recruiting
PhasePhase 1
Started2025-04-10
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 4 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 4 times since 2024-11-27; most recent amendment 2025-10-31. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-10-31
Status change Recruiting→Active, Not Recruitingv4
2025-05-30
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06714617
Lead Sponsor SystImmune Inc.
Conditions 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
Enrollment 120 participants
Start Date 2025-04-10
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-04