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Monoclonal Antibodies
INCA32459 for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by Incyte Corporation
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 up to 24 months
Awards & highlights
Study Summary
This trial will study how safe, tolerable and effective a drug is on advanced cancers. Part 1 will see if it has a max tolerated dose and Part 2 will assess safety, effectiveness, etc. at recommended dose.
Who is the study for?
This trial is for adults with certain advanced cancers who've had disease progression after standard treatments or can't tolerate them. It's open to those with specific types of melanoma and head/neck cancer, provided they haven't used LAG-3 therapy before and don’t have active brain metastases or autoimmune diseases requiring high-dose steroids.Check my eligibility
What is being tested?
The study tests INCA32459, a new bispecific antibody targeting LAG-3 and PD-1, in patients with select advanced malignancies. The first part determines the safest dose while the second part assesses its safety at that dose and how well it works against two specific types of tumors.See study design
What are the potential side effects?
Potential side effects aren't detailed here but may include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation in organs like lungs (pneumonitis), digestive issues, immune-related conditions due to overactivation of the immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Number of Participants discontinue study due to TEAE
Number of Participants with Dose Interruptions due to TEAE
+1 moreSecondary outcome measures
Disease Control Response (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 2: Dose Expansion Cohort Disease Group 2Experimental Treatment1 Intervention
INCA32459 will be administered at the recommended dose or doses for expansion (RDE[s]) for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) that is PD-L1 positive.
Group II: Part 2: Dose Expansion Cohort Disease Group 1Experimental Treatment1 Intervention
INCA32459 will be administered at the recommended dose or doses for expansion (RDE[s]) for unresectable or metastatic melanoma.
Group III: Part 1: Dose EscalationExperimental Treatment1 Intervention
INCA32459 will be administered at a protocol defined starting regimen intravenously. Subsequent dose regimens will be determined during study conduct.
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,175 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have another cancer that is getting worse or needs treatment.My cancer is confirmed by lab tests and is advanced.I still have side effects from previous treatments that are not mild.I haven't had cancer treatment or been in a clinical study in the last 28 days.I take more than 10 mg/day of prednisone or its equivalent.I am willing to have a new tumor biopsy.I haven't taken high-dose steroids or immunosuppressants for an autoimmune disease in the last 2 years.I haven't had major chest radiation or palliative radiation right before starting the study treatment.I am willing to have a new tumor biopsy for the study.I am fully active or can carry out light work.I am still experiencing side effects from my recent surgery or treatment.My brain cancer has not been treated or is getting worse.My condition worsened after standard treatment or I can't tolerate/qualify for it.I have not had LAG-3 or MHC Class II therapy for any cancer.My cancer is PD-L1 positive and cannot be treated with surgery or radiation aimed at curing it.I have or had lung scarring or inflammation not caused by infections.My melanoma is at stage III or IV and cannot be cured with surgery or other treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Dose Expansion Cohort Disease Group 1
- Group 3: Part 2: Dose Expansion Cohort Disease Group 2
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots currently in this investigation?
"According to clinicaltrials.gov,this experiment is no longer recruiting patients as of 11/17/2022 and its last update was on the same day. Although this trial has ended recruitment, there are 2381 other trials actively searching for participants right now."
Answered by AI
Could you please elucidate the primary purpose of this investigation?
"The sponsor of this study, Incyte Corporation, will measure the primary outcome - number of participants with dose interruptions due to treatment emergent adverse events - over a 12-month period. Additionally, they plan to assess secondary outcomes like apparent volume of distribution during terminal phase (Vz), concentration at the end of the dosing interval (Cmin), and time required to reach maximum plasma concentration following administration (tmax)."
Answered by AI
Has Part 1: Dose Escalation of the trial been endorsed by the FDA?
"The safety of the Part 1: Dose Escalation medication has been assessed as a score of 1 due to its Phase 1 designation, which signals that there is limited evidence on both its efficacy and safety."
Answered by AI
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