Clinical Trials /

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 in Subjects With Metastatic or Locally Advanced Solid Tumors.

NCT04242147

Description:

This is a First-in-Human, open-label, sequential dose-escalation and dose-expansion study of KD033 in adult subjects with advanced or metastatic solid tumors. The main purpose of this study is to test KD033 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 in Subjects With Metastatic or Locally Advanced Solid Tumors.
  • Official Title: A Phase 1, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 in Subjects With Metastatic or Locally Advanced Solid Tumors.

Clinical Trial IDs

  • ORG STUDY ID: KD033-101
  • NCT ID: NCT04242147

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
KD033 for InjectionMonotherapy

Purpose

This is a First-in-Human, open-label, sequential dose-escalation and dose-expansion study of KD033 in adult subjects with advanced or metastatic solid tumors. The main purpose of this study is to test KD033 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

Trial Arms

NameTypeDescriptionInterventions
MonotherapyExperimentalKD033 will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W)
  • KD033 for Injection

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed/documented advanced and/or metastatic solid
             tumor.

          -  Measurable disease per RECIST v1.1.

          -  Life expectancy of at least 3 months

          -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≤ 1.

          -  Adequate organ and bone marrow functions

          -  All toxicities related to prior radiotherapy, chemotherapy, or surgical procedure must
             have recovered to baseline or Grade ≤ 1 based on NCI-CTCAE v5.0,

          -  All subjects, male and female, who are not surgically sterilized or postmenopausal as
             defined above, must agree to use "highly effective methods of contraception"

          -  Other protocol-defined exclusion criteria could apply

        Exclusion Criteria:

          -  Use of immunotherapy, biological therapy, cytokine therapy < 21 days prior to the
             first dose of study drug

          -  Use of immunomodulating agents < 21 days prior to the first dose of study drug

          -  Use of chemotherapy and approved tyrosine kinase inhibitor (TKI) therapy < 14 days
             prior to the first dose of study drug

          -  Ongoing or recent (within 2 years) evidence of significant autoimmune disease that
             required systemic immunosuppressive treatments

          -  Systemic therapy with immunosuppressive agents including corticosteroids within 14
             days before the start of trial treatment

          -  Rapidly progressive disease which, in the opinion of Investigator, may predispose to
             inability to tolerate treatment or trial procedure

          -  History or clinical evidence of central nervous system primary tumors or metastases
             including leptomeningeal metastases unless they have been previously treated,
             demonstrated no progression at least 1 months, are asymptomatic and have had no
             requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before
             Screening - Subjects with suspected brain metastases at Screening should undergo a
             CT/MRI of the brain prior to study entry

          -  Active infection requiring therapy

          -  Other protocol-defined exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Treatment Emergent Adverse Events (TEAEs)
Time Frame:Up to 90 days after last treatment
Safety Issue:
Description:To evaluate the treatment Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Measure:Objective response rate (ORR) of KD033
Time Frame:Through study completion, an expected average of 1 year
Safety Issue:
Description:To evaluate the objective response rate (ORR) of KD033 based on investigator review of radiographic images

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kadmon Corporation, LLC

Last Updated

May 22, 2020