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

Overview

About this study

The purpose of this study is 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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/TGF?R? 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/27/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Babiker, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20531161

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