NCT05115292

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2021

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

October 20, 2021

Last Update Submit

November 7, 2023

Conditions

Advanced Solid Tumor or Lymphoma

Outcome Measures

Primary Outcomes (2)

  • To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study.

    60 days after the last dose

  • To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-005 following IV infusion in patients with advanced solid tumor or lymphoma.

    60 days after the last dose

Study Arms (2)

Arm1

EXPERIMENTAL

BJ-005 dose escalation

Biological: BJ-005

Arm 2

EXPERIMENTAL

BJ-005 cohort expansion

Biological: BJ-005

Interventions

BJ-005BIOLOGICAL

dosed with intravenous infusion

Arm 2Arm1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 18 years.
  • 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.
  • Histologically or cytologically confirmed advanced solid tumors or lymphoma
  • Measurable or evaluable disease per RECIST v1.1
  • ECOG performance status 0 or 1
  • Life expectancy ≥3 months
  • Adequate hepatic function
  • Calculated creatinine clearance (CrCL) \> 50 mL/min (Cockroft-Gault Equation)
  • Adequate Hematological function
  • Prothrombin time, international normalized ratio or activated partial thromboplastin time \< 1.5 × ULN
  • Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Mayo Clinic - Phoenix

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic - Florida

Jacksonville, Florida, 32224, United States

Location

Hematology/Oncology Assoc. of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Carolina BioOncology

Huntersville, North Carolina, 28078, United States

Location

Next Oncology

Austin, Texas, 78758, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Vicky Gao, MD

    BJ Bioscience, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 10, 2021

Study Start

October 20, 2021

Primary Completion

October 20, 2024

Study Completion

October 20, 2025

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

US(6)