RECRUITING

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

Conditions

Non Small Cell Lung Cancer NSCLC Lung Cancer Breast Cancer Esophageal Cancer SCLC Small Cell Lung Cancer NPC Nasopharyngeal Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

Quick Facts

Study Start:2023-08-08

Study Completion:2028-03-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05983432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Sign informed consent 2. Expected survival \> or = 3months 3. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: Non-Small Cell Lung Cancer, HER2- breast cancer, esophageal cancer, Small Cell Lung Cancer, and Nasopharyngeal Cancer 4. Agree to provide a tumor sample 5. Has at least one measurable lesion based on RECIST 1.1 6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 7. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.) 8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%. 9. Has adequate organ function before registration 10. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN 11. Urinary protein ≤2+ or ≤1000mg/24 hours 12. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating 13. Must agree to use adequate barrier contraceptive measures during the treatment and 6 months after the end of treatment for all subjects (regardless of gender)	1. 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 2. Subjects with history of severe heart disease 3. Active autoimmune diseases and inflammatory diseases 4. Other malignant tumors were diagnosed within 5 years 5. Subjects with poorly controlled hypertension 6. Subjects have Grade 3 lung disease or a history of interstitial lung disease 7. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening 8. Symptoms of active central nervous system metastasis 9. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1 10. Subjects have a history of autologous or allogeneic stem cell transplantation 11. Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection 12. Subjects with active infections requiring systemic treatment 13. Participated in another clinical trial within 4 weeks prior to participating in the study 14. Other conditions that the investigator believes that it is not suitable for participating in this clinical trial 15. Subjects with prolonged QT interval (QTc \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block 16. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2

Inclusion Criteria

Exclusion Criteria

1. Sign informed consent
2. Expected survival \> or = 3months
3. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: Non-Small Cell Lung Cancer, HER2- breast cancer, esophageal cancer, Small Cell Lung Cancer, and Nasopharyngeal Cancer
4. Agree to provide a tumor sample
5. Has at least one measurable lesion based on RECIST 1.1
6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
7. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.)
8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%.
9. Has adequate organ function before registration
10. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN
11. Urinary protein ≤2+ or ≤1000mg/24 hours
12. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating
13. Must agree to use adequate barrier contraceptive measures during the treatment and 6 months after the end of treatment for all subjects (regardless of gender)

1. 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
2. Subjects with history of severe heart disease
3. Active autoimmune diseases and inflammatory diseases
4. Other malignant tumors were diagnosed within 5 years
5. Subjects with poorly controlled hypertension
6. Subjects have Grade 3 lung disease or a history of interstitial lung disease
7. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening
8. Symptoms of active central nervous system metastasis
9. Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1
10. Subjects have a history of autologous or allogeneic stem cell transplantation
11. Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection
12. Subjects with active infections requiring systemic treatment
13. Participated in another clinical trial within 4 weeks prior to participating in the study
14. Other conditions that the investigator believes that it is not suitable for participating in this clinical trial
15. Subjects with prolonged QT interval (QTc \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block
16. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2

Contacts and Locations

Study Contact

Tara Barrineau

CONTACT

4254536841

tara.barrineau@systimmune.com

Whitney Eakins

CONTACT

whitney.eakins@systimmune.com

Principal Investigator

Clinical Leader

STUDY_DIRECTOR

SystImmune Inc.

Study Locations (Sites)

SystImmune Recruiting Site

Duarte, California, 91010

United States

SystImmune Recruiting Site

Orange, California, 92868

United States

SystImmune Recruiting Site

Boulder, Colorado, 80045

United States

SystImmune Recruiting Site

Miami, Florida, 33125

United States

SystImmune Recruiting Site

Port Saint Lucie, Florida, 34952

United States

SystImmune Recruiting Site

Louisville, Kentucky, 40202

United States

SystImmune Recruiting Site

Boston, Massachusetts, 02215

United States

SystImmune Recruiting Site

New York, New York, 10065

United States

SystImmune Recruiting Site

Greenville, South Carolina, 29605

United States

SystImmune Recruiting Site

Nashville, Tennessee, 37203

United States

SystImmune Recruiting Site

Dallas, Texas, 75230

United States

SystImmune Recruiting Center

Houston, Texas, 77030

United States

SystImmune Recruiting Site

Houston, Texas, 77030

United States

SystImmune Recruiting Site

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: SystImmune Inc.

Clinical Leader, STUDY_DIRECTOR, SystImmune Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-08

Study Completion Date2028-03-21

Study Record Updates

Study Start Date2023-08-08

Study Completion Date2028-03-21

Terms related to this study

Additional Relevant MeSH Terms

Non Small Cell Lung Cancer
NSCLC
Lung Cancer
Breast Cancer
Esophageal Cancer
SCLC
Small Cell Lung Cancer
NPC
Nasopharyngeal Cancer