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RecruitingPhase 1NCT05983432

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

Trial Parameters

ConditionNon Small Cell Lung Cancer
SponsorSystImmune Inc.
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment470
SexALL
Min Age18 Years
Max AgeN/A
Start Date2023-08-08
Completion2026-12-31
Interventions
BL-B01D1

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Brief Summary

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.

Eligibility Criteria

Inclusion criteria: 1. Signed the informed consent voluntarily and agreed to follow the program requirements 2. Either sex 3. Age: ≥18 years 4. Has a life expectancy of ≥3 months 5. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: NSCLC, HER2 - breast cancer, esophageal cancer, SCLC, NPC, and HNSCC. Has documented locally advanced or metastatic HER2 negative (by immunohistochemistry \[IHC\], score of 0 or 1) Hormone Receptor (HR) positive (HER2-, HR+) OR HER2 negative (IHC score of 0 to 2) HR negative breast cancer (HER2-, HR-) as per ASCO CAP criteria (ASCO CAP 2023; Wolff et al. 2023), not amenable to curative surgery or radiation with documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease, must have received 1 prior line of chemotherapy for advanced disease and, when applicable and if a

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