Monoclonal Antibodies

BJ-005 for Solid Tumor or Lymphoma

Hematology/Oncology Assoc. of the Treasure Coast, Port Saint Lucie, FL
BJ-005Phase 1RecruitingResearch Sponsored by BJ Bioscience, Inc.

Study Summary

This trial will study the safety and feasibility of a new drug, BJ-005, in patients with advanced cancer. The drug is a bifunctional molecule that targets the protein PD-L1.

Eligible Conditions
  • Advanced Solid Tumor or Lymphoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have fully recovered from any side effects of previous cancer treatments, with only mild or no symptoms remaining.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days after the last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days after the last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm1Experimental Treatment1 Intervention
BJ-005 dose escalation
Group II: Arm 2Experimental Treatment1 Intervention
BJ-005 cohort expansion

Find a site

Who is running the clinical trial?

BJ Bioscience, Inc.Lead Sponsor
1 Previous Clinical Trials
92 Total Patients Enrolled
Vicky Gao, MDStudy Director
BJ Bioscience, Inc.

Media Library

BJ-005 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05115292 — Phase 1
Solid Tumor or Lymphoma Research Study Groups: Arm 2, Arm1
Solid Tumor or Lymphoma Clinical Trial 2023: BJ-005 Highlights & Side Effects. Trial Name: NCT05115292 — Phase 1
BJ-005 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05115292 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively enrolling new participants?

"As indicated on, this medical trial is currently accepting participants. The initial post was published October 20th 2021 and the latest update occurred July 19th 2022."

Answered by AI

How perilous is BJ-005 for human subjects?

"Due to the limited clinical data available, BJ-005 was given a score of 1 for safety. As this is only a phase one trial there are minimal studies attesting to its efficacy and safety."

Answered by AI

How many healthcare centers are implementing this investigation?

"For this trial, patients can receive treatment at the Mayo Clinic in Florida and Arizona, as well as Hematology/Oncology Assoc. of the Treasure Coast located in North Carolina. Additionally, 6 other locations are currently involved with this study."

Answered by AI

How many people have volunteered to participate in this trial thus far?

"This medical trial requires 85 eligible patients, who fit the inclusionary criteria, to register. Participants may come from either Mayo Clinic - Florida (Jacksonville) or Mayo Clinic - Phoenix (Phoenix)."

Answered by AI
~0 spots leftby Oct 2023