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

NCT04418141 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-10-18

No results posted yet for this study

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

Interventions

DRUG

CN1

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.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Curon Biopharmaceutical (Australia) Co Pty Ltd

    lead INDUSTRY

Principal Investigators

  • John Park · Macquarie University Hospital

  • Jim Coward · Icon Cancer Centre (Brisbane)

  • Daniel Brungs · Illawarra Cancer Care Centre (Wollongong)

  • Gary Richardson · Cabrini Hospital (Melbourne)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2021-10-07
Completion
2021-10-07

Countries

  • Austria

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04418141 on ClinicalTrials.gov