KD033 for Injection for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cancer+1 More
KD033 for Injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, KD033, on adults with advanced solid tumors. The goal is to see if it is safe and effective.

Eligible Conditions
  • Cancer
  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: Through study completion, an average of 1 year

Year 1
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Year 1
Best Overall Response (BOR)
Changes in immune correlates in peripheral blood
Duration Of Response (DOR)
Exploration of Anti-KD033 Antibodies
Exploration of KD033 Pharmacokinetic (PK) Profile - AUC
Exploration of KD033 Pharmacokinetic (PK) Profile - Cmax
Exploration of PFS and OS
Exploration of immune correlates/other biomarkers of KD033 in blood and tumor.
Day 90
Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity
Week 5
Occurrence of Dose Limiting Toxicities (DLTs)

Trial Safety

Trial Design

3 Treatment Groups

Monotherapy
1 of 3
Weekly Monotherapy Dosing Regimen
1 of 3
Bi-weekly Monotherapy Dosing Regimen
1 of 3
Experimental Treatment

50 Total Participants · 3 Treatment Groups

Primary Treatment: KD033 for Injection · No Placebo Group · Phase 1

Monotherapy
Drug
Experimental Group · 1 Intervention: KD033 for Injection · Intervention Types: Drug
Weekly Monotherapy Dosing Regimen
Drug
Experimental Group · 1 Intervention: KD033 for Injection · Intervention Types: Drug
Bi-weekly Monotherapy Dosing Regimen
Drug
Experimental Group · 1 Intervention: KD033 for Injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

Kadmon Corporation, LLCLead Sponsor
37 Previous Clinical Trials
1,706 Total Patients Enrolled
Kadmon, a Sanofi CompanyLead Sponsor
9 Previous Clinical Trials
518 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a solid tumor with at least one tumor lesion accessible to biopsy.
Subjects must be willing to use highly effective methods of contraception for at least 60 days after the last dose of KD033.
Subjects must be willing to undergo a tumor biopsy at the following time points: Pre-treatment and at Cycle 4, Day 1
You have a performance status of 0 or 1.
You are a woman of childbearing potential.
You are able to understand the purpose of the study, provide signed and dated informed consent from the subject/legal representative prior to performing any protocol-related procedures and able to comply with the study procedures and any locally required authorization.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.