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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2025-10-20

Brief Summary

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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).

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Detailed Description

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Conditions

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Advanced Solid Tumor or Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1

BJ-005 dose escalation

Group Type EXPERIMENTAL

BJ-005

Intervention Type BIOLOGICAL

dosed with intravenous infusion

Arm 2

BJ-005 cohort expansion

Group Type EXPERIMENTAL

BJ-005

Intervention Type BIOLOGICAL

dosed with intravenous infusion

Interventions

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BJ-005

dosed with intravenous infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No