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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
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 moreTrial 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).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include immune checkpoint inhibitors, targeted therapies, and traditional chemotherapies. Immune checkpoint inhibitors enhance the immune system's ability to attack cancer cells by blocking proteins that inhibit immune responses.
Targeted therapies disrupt specific molecular pathways essential for tumor growth and survival. Traditional chemotherapies kill rapidly dividing cells, including cancer cells, but can also affect normal cells.
These mechanisms are important for solid tumor patients as they guide the selection of treatments that offer the best balance between efficacy and side effects.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any other health problems, abnormal test results, or physical exam findings that could affect your participation in the study.You have taken chemotherapy or certain medications for cancer within the past 14 days before starting the study drug.You have a disease that is getting worse quickly, and the doctor thinks it may make it difficult for you to handle the treatment or the trial procedures.You are expected to live for at least 3 more months.You have not received immunotherapy, biological therapy, or cytokine therapy in the 21 days before starting the study drug.You have a serious autoimmune disease that needed strong medicines to control it in the past two years.You have a history of serious lung disease that affects your breathing.You have a serious heart or blood vessel condition.You have had serious allergic reactions to similar types of medications in the past, or you have experienced a severe allergic reaction called anaphylaxis in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion
- Group 2: Bi-weekly Monotherapy Dose Escalation (Q2W)
- Group 3: Weekly Monotherapy Dose Escalation (Q1W)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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