What side effects are associated with this type of intervention?

Common treatments for cancer similar to the antitumor agent INCA32459, such as immunotherapies and targeted therapies, often have side effects that include fatigue, diarrhea, skin toxicities (e.g., rash or erythema), and gastrointestinal issues like nausea and decreased appetite. Severe adverse events can include pneumonitis, hepatic adverse events, and infusion-related reactions. These treatments can also lead to immune-related side effects requiring management with steroids or other immunosuppressive agents.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for cancer treatment, particularly those targeting immune checkpoints. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors approved for various cancers, including melanoma and non-small cell lung cancer. Ipilimumab (Yervoy), a CTLA-4 inhibitor, is approved for melanoma. Combination therapies, such as nivolumab plus ipilimumab, have also been approved for advanced melanoma. These treatments enhance the immune system's ability to fight cancer, similar to the investigational agent INCA32459, which targets LAG-3 and PD-1.

What other types of research exist?

Promising novel alternatives to INCA32459 for cancer patients include: 1) Combination of nivolumab and ipilimumab, which has shown significant clinical benefits in advanced melanoma and renal cell carcinoma. 2) Pembrolizumab, which has demonstrated efficacy in metastatic renal cell carcinoma and other malignancies. 3) Atezolizumab plus bevacizumab, which has shown improved outcomes in renal cell carcinoma. 4) CMAB009 plus irinotecan, which has been effective as a second-line treatment in metastatic colorectal cancer. 5) Aflibercept in combination with irinotecan and fluorouracil, which has shown significant improvement in metastatic colorectal cancer.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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 more

Secondary study objectives

Disease Control Response (DCR)

Duration of Response (DOR)

Objective Response Rate (ORR)

+8 more

Awards & 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.

Do I qualify?Apply below to find out

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.

Promising novel therapies for the treatment of endometrial cancer.