INCA32459 for Advanced Cancer

Recruiting at 33 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Systemic steroids

Disqualifiers: Interstitial lung disease, Active autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

46 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had anticancer therapies or participated in another clinical study within 28 days before starting this trial. Chronic treatment with systemic steroids over 10 mg/day of prednisone or equivalent is also not allowed.

How does the drug INCA32459 differ from other treatments for advanced cancer?

INCA32459 is likely an immune checkpoint inhibitor (ICI), which is a type of drug that helps the immune system recognize and attack cancer cells. This approach is different from traditional cancer treatments because it targets specific proteins that prevent the immune system from attacking cancer cells, potentially leading to more durable responses in some patients. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

My cancer is confirmed by lab tests and is advanced.

I am willing to have a new tumor biopsy.

Measurable disease according to RECIST v1.1

Exclusion Criteria

I do not have another cancer that is getting worse or needs treatment.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 involves dose escalation to determine the recommended dose and maximum tolerated dose of INCA32459

Up to 12 months

Dose Expansion

Part 2 involves dose expansion to further evaluate safety, tolerability, and preliminary antitumor activity at the recommended dose(s)

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

Treatment Details

Interventions

• INCA32459

Trial Overview 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.

Participant Groups

Group I: Part 2: Dose Expansion Cohort Disease Group 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 Escalation Experimental Treatment 1 Intervention

INCA32459 will be administered at a protocol defined starting regimen intravenously. Subsequent dose regimens will be determined during study conduct.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Findings from Research

In a study of 65 patients undergoing interventional oncology therapies combined with immune checkpoint inhibitors, only 10.8% experienced immune-related adverse events (irAEs), mostly mild and manageable, indicating a favorable safety profile for this combination treatment.

The study found no severe complications (grade 5) related to the procedures or irAEs within 90 days, suggesting that combining tumor-directed therapies with immune checkpoint inhibitors is safe and does not lead to unexpected toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal Ablation, Embolization, and Selective Internal Radiation Therapy Combined with Checkpoint Inhibitor Cancer Immunotherapy: Safety Analysis. Leppelmann, KS., Mooradian, MJ., Ganguli, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Thermal Ablation, Embolization, and Selective Internal Radiation Therapy Combined with Checkpoint Inhibitor Cancer Immunotherapy: Safety Analysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Immune checkpoint inhibitors: new strategies to checkmate cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Predictive factors of neoadjuvant immune checkpoint blockade in melanoma. [2022]

4. England pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA-Mutated Metastatic Castrate-Resistant Prostate Cancer. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Metastatic Castration-Resistant Prostate Cancer, Immune Checkpoint Inhibitors, and Beyond. [2023]