Lung Cancer Clinical Trial

Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC)

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).

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Full Description

BL-B01D1-LUNG-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics , and initial efficacy of BL-B01D1 in participants with metastatic or unresectable NSCLC.

This study will be conducted in two different dosing schedules (Cohort A and Cohort B) and three parts (dose escalation, dose finding and dose expansion). Cohort A will be dosed on Day 1 and Day 8 of a continuous 21-day treatment cycle. Cohort B will be dosed on Day 1 of a continuous 21-day treatment cycle. Each Cohort has different dose groups.

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Eligibility Criteria

Inclusion Criteria:

Sign informed consent
Age: ≥18 years
Expected survival > or = 3months
Has documented locally advanced or metastatic NSCLC, 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.
Agree to provide a tumor sample
Has at least one measurable lesion based on RECIST 1.1
Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1

Exclusion Criteria:

Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Mixed small-cell lung cancer (SCLC) and NSCLC histology
Subjects with history of severe heart disease
Active autoimmune diseases and inflammatory diseases
Other malignant tumors were diagnosed within 5 years
Subjects with poorly controlled hypertension
Subjects have Grade 3 lung disease or a history of interstitial lung disease
Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening
Symptoms of active central nervous system metastasis.
Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1
Subjects have a history of autologous or allogeneic stem cell transplantation
Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection
Subjects with active infections requiring systemic treatment
Participated in another clinical trial within 4 weeks prior to participating in the study
Other conditions that the investigator believes that it is not suitable for participating in this clinical trial

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05983432

Recruitment Status:

Recruiting

Sponsor:

SystImmune Inc.

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There are 6 Locations for this study

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SystImmune Recruiting Center
Port Saint Lucie Florida, 34952, United States
SystImmune Recruiting Center
New York New York, 10065, United States
SystImmune Recruiting Center
Greenville South Carolina, 29605, United States
SystImmune Recruiting Center
Nashville Tennessee, 37203, United States
SystImmune Recruiting Center
Dallas Texas, 75230, United States
SystImmune Recruiting Site
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05983432

Recruitment Status:

Recruiting

Sponsor:


SystImmune Inc.

How clear is this clinincal trial information?

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