← Back to Search

Monoclonal Antibodies

KD033 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Kadmon Corporation, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an expected average of 1 year

Awards & highlights

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.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors who can provide tumor biopsies, have recovered from previous treatments to a certain degree, and have measurable disease. They must be able to perform daily activities with minimal assistance (ECOG PS ≤1), have good organ/bone marrow function, use effective contraception if applicable, and not be pregnant.Check my eligibility

What is being tested?

KD033 (SAR445710) is being tested in this Phase 1 study where participants receive varying doses either weekly or every two weeks. The goals are to determine the safety and tolerability of KD033, its potential anti-cancer effects, and how it's processed by the body.See study design

What are the potential side effects?

While specific side effects for KD033 are not listed here as it's an early-stage trial assessing safety, common side effects may include reactions at the injection site, fatigue, nausea, fever-like symptoms due to immune system activation or other drug-related adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an expected average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an expected average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an expected average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Dose Limiting Toxicities (DLTs)

Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs by Severity

Secondary outcome measures

Best Overall Response (BOR)

Duration Of Response (DOR)

Exploration of Anti-KD033 (SAR445710) Antibodies

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Weekly Monotherapy Dose Escalation (Q1W)Experimental Treatment1 Intervention

KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration once a week (QW) for 6 weeks and then every 2 week-dosing.

Group II: Dose ExpansionExperimental Treatment1 Intervention

KD033 (SAR445710) will be administered at recommended dose/schedule for expansion

Group III: Bi-weekly Monotherapy Dose Escalation (Q2W)Experimental Treatment1 Intervention

KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kadmon Corporation, LLCLead Sponsor

37 Previous Clinical Trials

1,666 Total Patients Enrolled

Kadmon, a Sanofi CompanyLead Sponsor

13 Previous Clinical Trials

626 Total Patients Enrolled

Media Library

KD033 (SAR445710) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04242147 — Phase 1

Solid Tumors Research Study Groups: Dose Expansion, Bi-weekly Monotherapy Dose Escalation (Q2W), Weekly Monotherapy Dose Escalation (Q1W)

Solid Tumors Clinical Trial 2023: KD033 (SAR445710) Highlights & Side Effects. Trial Name: NCT04242147 — Phase 1

KD033 (SAR445710) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04242147 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what areas can this clinical trial be accessed?

"Participants of this medical study may be recruited from UCLA Hematology/Oncology, 2020 Santa Monica Boulevard, Suite 600 - Site 042 in Santa Monica, Fox Chase Cancer Center - 333 Cottman Avenue - Site 141 in Philadelphia and University of Pittsburgh Medical Center - Hillman Cancer Center – 5150 Centre Avenue, Suite 301 – Site 132 in Pittsburgh. Additionally there are 8 other sites available for clinical trial recruitment."

Answered by AI

What outcomes is this trial seeking to ascertain?

"The principal goal of this trial, which will be monitored up to week 5 of treatment, is the tracking and categorization of Treatment Emergent Adverse Events (TEAEs) and any correlated TEAEs based on severity. Additional objectives include surveying Progression-Free Survival (PFS) and Overall Survival (OS), Duration Of Response (DOR), as well as evaluating alterations in immune correlates within peripheral blood for furthering comprehension into its mode of action."

Answered by AI

How many people are participating in this experiment?

"Indeed, clinicaltrials.gov details that this experiment is still recruiting applicants. Its initial posting was on June 3rd 2020 and the most recent update being July 6th 2022. The trial calls for 50 participants from 8 trials sites to be enrolled in total."

Answered by AI

To what degree does KD033 for Injection endanger participants' health?

"As this is an early stage trial, with limited data to support safety and efficacy of KD033 for injection, our team assigned it a score of 1 on the scale."

Answered by AI

Are any openings available for this trial currently?

"Affirmative, the data on clinicaltrials.gov attests to this medical trial's ongoing recruitment efforts which commenced in June 2020 and were most recently updated in July 2022. The study aims to enroll fifty individuals from eight different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors

2023. "A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04242147.