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

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SystImmune Inc.

Criteria

Inclusion 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

Exclusion Criteria:

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