BAT7104 Injection in Patients With Advanced Malignant Tumors.

NCT05767060 | Completed Phase 1

• 1 other identifier: BAT-7104-001-CR
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-center, open phase Ia/Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT),

  umber of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0.

  A minimum of 28 days after first dose of BAT-7104

• Adverse Events (AEs)

  Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0.

  AE needs continuous monitoring and evaluation from the first administration to 90 days after the last administration or before receiving new anti-tumor treatment.

Secondary Outcomes (8)

• Cmax,

  up to Cycle 6, each cycle is 14 days

• Anti-drug antibodies (ADA) and neutralizing antibodies (NAb)

  up to Cycle 6, each cycle is 14 days

• Objective response rate (ORR)

  12 months (anticipated)

• Tmax (Time to reach maximum serum concentration)

  up to Cycle 6, each cycle is 14 days

• AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration

  up to Cycle 6, each cycle is 14 days

Study Arms (7)

BAT7104 Injection 0.1 mg/kg

EXPERIMENTAL

frequency: Q2W

Drug: BAT7104 injection

BAT7104 Injection 0.3 mg/kg

EXPERIMENTAL

frequency: Q2W

Drug: BAT7104 injection

BAT7104 Injection 1 mg/kg

EXPERIMENTAL

frequency: Q2W

Drug: BAT7104 injection

BAT7104 Injection 3 mg/kg

EXPERIMENTAL

frequency: Q2W

Drug: BAT7104 injection

BAT7104 Injection 10 mg/kg

EXPERIMENTAL

frequency: Q2W

Drug: BAT7104 injection

BAT7104 Injection 20 mg/kg

EXPERIMENTAL

frequency: Q2W

Drug: BAT7104 injection

BAT7104 Injection 40 mg/kg

EXPERIMENTAL

frequency: Q2W

Drug: BAT7104 injection

Interventions

BAT7104 injection DRUG

According to the protocol, each dose group is given intravenous infusion at the rate of mg/kg, and the recommended infusion time is ≥ 60 minutes. Once every two weeks (Q2W), on the first day of each cycle.

Also known as: Recombinant anti-PD-L1/CD47 bispecific antibody injection

BAT7104 Injection 0.1 mg/kg; BAT7104 Injection 0.3 mg/kg; BAT7104 Injection 1 mg/kg; BAT7104 Injection 10 mg/kg; BAT7104 Injection 20 mg/kg; BAT7104 Injection 3 mg/kg; BAT7104 Injection 40 mg/kg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years old and ≤ 80 years old, gender: male or female;
• The investigator evaluated the expected survival period to be at least 3 months;
• The requirement of the ECOG physical fitness score is 0 or 1;
• Patients with advanced malignant tumors who have failed to receive standard treatment, have no standard treatment, do not tolerate standard treatment or refuse to accept standard treatment confirmed by cytology or pathology;
• There must be an evaluable tumor focus in the dose increasing stage, and at least one measurable tumor focus in the dose expanding stage (solid tumors refer to RECIST 1.1 standard, lymphoma refer to Lugano 2014 evaluation standard);
• It has sufficient organ and bone marrow reserve function, which is defined as follows:
• System laboratory reference value:
• Blood routine (no blood transfusion, no use of hematopoietic stimulating factor and no use of drugs to correct blood cell count within 14 days before the first administration):
• Absolute neutrophil count ≥ 1.5 x 109/L;Platelet count ≥ 90 x109/L;Hemoglobin ≥ 90g/L;
• Coagulation function:
• International standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5xULN (without anticoagulant treatment), those who receive oral anticoagulant treatment and whose INR is 2\~3 can be included.
• Liver function:
• Total bilirubin (TBIL) ≤ 1.5xULN;Hepatocellular carcinoma, Gilbert's syndrome, liver metastasis ≤ 2xULN;Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5xULN;Hepatocellular carcinoma, liver metastasis ≤ 5xULN renal function Serum creatinine or Serum creatinine clearance ≤ 1.5xULN or\>50ml/min (using Cockcroft-Gault formula, see appendix)

You may not qualify if:

• Have received any anti-CD47 antibody and SIRP within 4 weeks before the first administration α Antibodies or CD47/SIRP α Recombinant protein therapy;
• He has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first use of the study drug, with the exception of the following: ① nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small-molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); ③ The systematic treatment of traditional Chinese medicine/proprietary Chinese medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.) is within 2 weeks before the first use of the study drug;
• Inoculated or planned to receive live/attenuated vaccine and mRNA vaccine within 4 weeks before screening;
• Pregnant or lactating women;
• AEs caused by previous anti-tumor therapy are still higher than grade 1 (based on CTCAE v5.0) before the first administration of the study drug (except for AEs such as hair loss and fatigue that cannot be restored to ≤ grade 1 and will remain stable for a long time according to the judgment of the researcher based on clinical actual conditions, except for grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy);
• Those who have had ≥ 3 levels of irAE in the past or have terminated immunotherapy due to any level of irAE;
• Primary central nervous system tumor, central nervous system metastasis with related symptoms, meningeal metastasis or previous history of epilepsy should be excluded. Patients with asymptomatic or asymptomatic central nervous system metastasis who have been clinically controlled but have been judged stable by the researcher can be included, but the following conditions must be met at the same time: a The disease was stable ≥ 4 weeks before the first administration; B. No evidence of central nervous system disease progression was found in MRI enhancement of the head within 4 weeks before the first administration; C. The anticonvulsant drugs have been stopped at least 2 weeks before the first administration, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of hormone;
• Patients who have undergone major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial period;
• Have a history of tissue or organ transplantation;
• Patients with severe infection within 4 weeks before the first medication, including but not limited to infection complications, bacteremia, severe pneumonia, etc. requiring hospitalization; Patients with active infection before the first administration were excluded;
• Known history of human immunodeficiency virus (HIV) infection;
• Active hepatitis B, untreated chronic hepatitis B or treated but uncontrolled chronic hepatitis B (HBV DNA\>200 IU/mL or\>103 copies/ml);
• Active HCV infected patients (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
• Untreated or under treatment tuberculosis patients, including but not limited to tuberculosis; Those who have received standard anti-tuberculosis treatment and have been confirmed as cured by researchers can be included;
• Known to have a history of severe allergy, or known to have had ≥ grade 3 allergic reaction to macromolecular protein preparation/monoclonal antibody, and any component of test drug;

Sponsors & Collaborators

• Bio-Thera Solutions: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Li Zhang

Guangzhou, Guangdong, China

Location

Study Officials

• Li Zhang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 14, 2023
• Study Start: January 20, 2022
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)