A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma

BJ Bioscience

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Solid Tumor or Lymphoma

Treatments: Biological: BJ-005

Study type: Interventional

Funder types: Industry

Identifiers

NCT05115292

BJ-005-01-001US

Details and patient eligibility

About

This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥ 18 years.
2. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
3. Histologically or cytologically confirmed advanced solid tumors or lymphoma
4. Measurable or evaluable disease per RECIST v1.1
5. ECOG performance status 0 or 1
6. Life expectancy ≥3 months
7. Adequate hepatic function
8. Calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation)
9. Adequate Hematological function
10. Prothrombin time, international normalized ratio or activated partial thromboplastin time < 1.5 × ULN
11. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy

Exclusion criteria

1. Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment.
2. Symptomatic primary central nervous system (CNS) tumor of CNS metastases.
3. Uncontrolled hypertension.
4. Significant thrombotic or hemorrhagic events.
5. Prior CAR-T therapy
6. Severe cardiovascular disease.
7. Active infection requiring therapy
8. Active HIV, hepatitis B or hepatitis C virus
9. Active tuberculosis
10. Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry
11. Pregnant or breast-feeding females
12. Active or history of autoimmune disease or inflammatory disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Arm1

Experimental group

Description:

BJ-005 dose escalation

Treatment:

Biological: BJ-005

Arm 2

Experimental group

Description:

BJ-005 cohort expansion

Treatment:

Biological: BJ-005