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

NCT04418141 | Completed Phase 1

• 1 other identifier: CN1-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumor; B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• To determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended Phase II dose (RP2D) of CN1 administered to patients with advanced solid tumor or B-cell lymphoma.

  DLT is measured in the observation period of 21 days after the first dose i.e. starting dose level 0.03 mg/kg. if the enrolled subject does not experience a study drug related Grade 2 or higher adverse event (AE) per NCI-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, the subject will start to receive the next designated dose level of 0.3 mg/kg in the second 21 days dosing cycle.

  21 Days after the first dose i.e. starting dose level 0.03 mg/kg

Secondary Outcomes (10)

• To assess the safety and tolerability of CN1 in patients with advanced solid tumor or B-cell lymphoma through Physical Exam

  From baseline(Week 1) to 90 days after the last dose

• To assess the safety and tolerability of CN1 in patients with advanced solid tumor or B-cell lymphoma through Adverse Events/Serious Adverse Events

  From baseline(Week 1) to 90 days after the last dose

• To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Area under the plasma concentration-time curve

  Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.

• To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Tmax

  Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.

• To assess the pharmacokinetic (PK) profile of CN1 in patients with advanced solid tumor or B-cell lymphoma through Apparent volume of distribution at steady state

  Measurement is through treatment completion starting from Week 1 up to End of Treatment, assessed up to an average of 10 weeks.

Study Arms (1)

Single Arm

EXPERIMENTAL

Five planned CN1 dose levels of 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg. Subjects will receive CN1 by intravenous infusion (IV) on Day 1 (D1) of each cycle (once every 3 weeks per cycle).

Drug: CN1

Interventions

CN1 DRUG

Participants will receive CN1 by IV infusion on Day 1 of each cycle (every 3 weeks). The 5 planned dose levels are 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg and 10 mg/kg.

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Curon Biopharmaceutical (Australia) Co Pty Ltd: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Mater Medical Centre

Brisbane, Queensland, 4101, Austria

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• John Park

  Macquarie University Hospital

  PRINCIPAL INVESTIGATOR

• Jim Coward

  Icon Cancer Centre (Brisbane)

  PRINCIPAL INVESTIGATOR

• Daniel Brungs

  Illawarra Cancer Care Centre (Wollongong)

  PRINCIPAL INVESTIGATOR

• Gary Richardson

  Cabrini Hospital (Melbourne)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: June 5, 2020
• Study Start: July 2, 2020
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)