Overview

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
All
Summary
In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborator:
SystImmune Inc.
Criteria
Inclusion Criteria:

1. Participants must sign the informed consent form voluntarily and follow the plan
requirements.

2. No gender limit.

3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib).

4. Expected survival time ≥ 3 months.

5. Locally advanced or metastatic solid tumor confirmed by histopathology and/or
cytology, which are incurable or currently without standard treatment.

6. Participants must agree to provide archived tumor tissue specimens or fresh tissue
samples within 6 months of the primary tumor or metastasis; in phase Ia, if the
participant is unable to provide tumor tissue samples, the investigator will evaluate
whether the participant could be enrolled if other criteria are fit to join the group.

7. Participants must have at least one measurable lesion that meets the definition of
RECIST v1.1.

8. Physical fitness score ECOG 0 or 1 point

9. The toxicity of previous anti-tumor treatments has been restored to NCI-CTCAE v5.0
definition ≤ 1 (except for hair loss).

10. No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%

11. The organ function must meet the following requirements and standards: a) Bone marrow
function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥75×109/L,
hemoglobin ≥90 g/L; B) Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT
≤2.5 ULN for participants without liver metastasis, AST and ALT ≤5.0 ULN for liver
metastases; c) Kidney function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance
(Ccr) ≥50 mL/min (according to the Cockcroft and Gault formula).

12. Coagulation function: International normalized ratio (INR)≤1.5×ULN, and activated
partial thromboplastin time (APTT)≤1.5ULN.

13. Urine protein≤2+ (measured with test paper) or≤1000mg/24h (urine).

14. 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; all participants (regardless of male or female) in
the group should be treated throughout the treatment. Adequate barrier contraceptive
measures should be taken during the treatment and 6 months after the treatment.

Exclusion Criteria:

1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery,
targeted therapy (including small molecule inhibitor of tyrosine kinase), and other
anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the
first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the
first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or
palliative radiotherapy within 2weeks prior to the first administration.

2. Participants with history of severe heart disease, such as: symptomatic congestive
heart failure (CHF) ≥ grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ grade 2
heart failure, history of transmural myocardial infarction, unstable angina pectoris
etc.

3. Participants with prolonged QT interval (male QTc> 450 msec or female QTc> 470 msec),
complete left bundle branch block, III grade atrioventricular block.

4. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus
erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis,
inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for type I
diabetes, hypothyroidism that can be controlled only by alternative treatment, and
skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).

5. Other malignant tumors were diagnosed within 5 years prior to the first administration
with the following exceptions: basal cell carcinoma of the skin, squamous cell
carcinoma of the skin and/or carcinoma in situ after radical resection.

6. Participants with poorly controlled hypertension by two kinds of antihypertensive
drugs (systolic blood pressure>150 mmHg or diastolic blood pressure>100 mmHg).

7. Participants have grade 3 lung disease defined according to NCI-CTCAE v5.0, or a
history of interstitial lung disease (ILD).

8. Symptoms of active central nervous system metastasis. However, participants with
stable brain metastasis can be included. Stable is defined as: a. With or without
antiepileptic drugs, the seizure-free state lasts for more than 12 weeks; b. There is
no need to use glucocorticoids; c. Continuous multiple MRI (scanning interval at least
8 weeks) showed a stable state in imaging.

9. Participants who have a history of allergies to recombinant humanized antibodies or
human-mouse chimeric antibodies or any of the components of BL-B01D1.

10. Participants have a history of autologous or allogeneic stem cell transplantation.

11. In the adjuvant (or neoadjuvant) treatment of anthracyclines, the cumulative dose of
anthracyclines is> 360 mg/m2.

12. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active
hepatitis B virus infection (HBV-DNA copy number> the lower limit of detection) or
active hepatitis C virus infection(HCV antibody positive and HCV-RNA > the lower limit
of detection).

13. Participants with active infections requiring systemic treatment, such as severe
pneumonia, bacteremia, sepsis, etc.

14. Participated in another clinical trial within 4 weeks prior to participating in the
study.

15. Other conditions that the investigator believes that it is not suitable for
participating in this clinical trial.