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Monoclonal Antibodies

BJ-005 for Solid Cancers and Lymphoma

Phase 1

Waitlist Available

Research Sponsored by BJ Bioscience, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation)

Histologically or cytologically confirmed advanced solid tumors or lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days after the last dose

Awards & highlights

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.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors or lymphoma who have recovered from previous cancer treatments. They must be able to consent, have a life expectancy of at least 3 months, and meet certain health criteria like good liver function and no severe heart issues. People with prior PD-L1/TGFβRⅡ treatment, active infections including HIV/HBV/HCV, recent anticancer therapy, pregnancy, autoimmune diseases, or uncontrolled hypertension cannot join.Check my eligibility

What is being tested?

The study tests BJ-005 in patients for the first time. It's a Phase 1 trial focusing on safety and how the body processes the drug. BJ-005 is an experimental molecule combining an anti-PD-L1 antibody with part of TGF-β receptor II aimed at treating advanced cancers.See study design

What are the potential side effects?

Potential side effects are not fully known since this is a first-in-human study but may include typical reactions to monoclonal antibodies such as infusion-related reactions, immune system effects causing inflammation in organs (like colitis), fatigue, skin rash or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine clearance, is good.

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My cancer diagnosis was confirmed through tissue or cell testing.

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I have recovered from side effects of previous cancer treatments.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days after the last dose

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.

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

BJ Bioscience, Inc.Lead Sponsor

1 Previous Clinical Trials

92 Total Patients Enrolled

Vicky Gao, MDStudy DirectorBJ Bioscience, Inc.

Media Library

BJ-005 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05115292 — Phase 1

Solid Tumor or Lymphoma Research Study Groups: Arm1, Arm 2

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 clinicaltrials.gov, 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

Recent research and studies

clinicaltrials.govStudy

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

2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05115292.