A Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of CN1

  • STATUS
    Recruiting
  • participants needed
    22
  • sponsor
    Curon Biopharmaceutical (Australia) Co Pty Ltd
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Updated on 19 February 2024
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solid tumour
lymphoma
b-cell lymphoma

Summary

This study is the first-in-human clinical trial of CN1 to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of CN1 in patients with advanced solid tumors or B-cell lymphoma. This study will provide a basis for further clinical development of CN1.

Description

CN1 could promote T cell activation and cytokine secretion, thereby enhancing the function of CD4+ and CD8+ T cells, and could also regulate Treg cells, thus CN1 is considered to enhance the anti-tumor immune response and have potential antitumor activity.

In this multicenter, open-label, dose-escalation Phase I study six dose levels are planned. Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). After completion of treatment cycles, the participant will be assessed by the Principal Investigator and/or Safety Monitoring Committee (SMC).

Details
Condition Lymphoma, B-Cell Lymphoma, Advanced Solid Tumor
Age 18-75 years
Treatment CN1
Clinical Study IdentifierNCT04418141
SponsorCuron Biopharmaceutical (Australia) Co Pty Ltd
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 years and 75 years old, male or female
Subjects with histologically or cytologically diagnosed advanced malignant solid tumors or B-cell lymphoma who have failed on, or are intolerant to, standard therapy, for whom there are no standard of care regimens, or who are otherwise not eligible for standard therapy at this stage
Subjects with Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from screening until the end of the follow-up period
Subjects must be able to understand and sign the paper informed consent before any study specific procedure

Exclusion Criteria

Received anti-tumor treatment such as radiotherapy, chemotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 4 weeks prior to the first dose of study drug
Received other investigational agents (not yet approved by any regulatory agency) within 4 weeks prior to the first dose of study drug
Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose of study drug
Systemic application of corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of study drug
Exceptions: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, or short-term corticosteroids for prophylaxis (e.g., contrast allergy prophylaxis)
Use of live attenuated vaccine within 4 weeks prior to the first dose of study drug
Clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the central nervous system or meninges of the subject
Active infection and in current need of, or likely to need, intravenous anti-infective therapy
History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody
Active hepatitis B or hepatitis C virus infection
Subjects with active or previous autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except subjects with clinically stable autoimmune thyroid disease
Subjects with mental disorders or other conditions that pose high non-compliance risks in the opinion of the investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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