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Monoclonal Antibodies
INCA32459 for Advanced Cancer
Phase 1
Waitlist Available
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
No Placebo-Only Group
Summary
This trial is testing a new drug called INCA32459 to see if it is safe and effective for people with advanced cancer. The study will look at how the drug moves through and affects the body. Researchers hope to find out if INCA32459 can help control or shrink tumors.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Therapeutic procedure
Number of Participants discontinue study due to TEAE
Number of Participants with Dose Interruptions due to TEAE
+1 moreSecondary study objectives
Disease Control Response (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
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 cancer treatments, particularly immunotherapies and targeted therapies, work by enhancing the body's immune response or targeting specific molecules involved in cancer cell growth and survival. For example, INCA32459 is a bispecific antibody that targets LAG-3 and PD-1, both of which are immune checkpoints that cancer cells exploit to evade immune detection.
By inhibiting these checkpoints, such treatments can reactivate the immune system to recognize and destroy cancer cells. This is significant for cancer patients as it provides a more personalized treatment approach, potentially leading to better outcomes and fewer side effects compared to conventional therapies.
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
388 Previous Clinical Trials
63,589 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.
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