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.

Eligibility Criteria Checklist

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

Must have

Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up60 days after the last dose

Awards & highlights

No Placebo-Only Group

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

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You have fully recovered from any side effects of previous cancer treatments, with only mild or no symptoms remaining.

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.

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

0 / 1Eligibility criteria met

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 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.