What is the mechanism of action of this treatment?

Common treatments for Squamous Cell Carcinoma (SCC) include surgical excision, radiation therapy, and systemic therapies such as chemotherapy and immunotherapy. Immunotherapy, particularly immune checkpoint inhibitors like anti-PD-1/PD-L1 and anti-CTLA-4 antibodies, works by blocking proteins that prevent the immune system from attacking cancer cells. Small molecule inhibitors, such as those targeting the hedgehog pathway, inhibit specific proteins involved in tumor growth and survival. Understanding these mechanisms is crucial for SCC patients as it helps in selecting the most effective treatment strategy, potentially improving outcomes and minimizing side effects.

What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma, particularly those involving small molecule inhibitors or biologic agents targeting tumor growth or immune evasion pathways, often lead to side effects such as dermatologic toxicities (rash, pruritus), gastrointestinal issues (diarrhea, colitis), hepatic toxicities (hepatitis), and endocrine disorders (thyroid dysfunction). These side effects are frequently observed with immune checkpoint inhibitors targeting PD-1/PD-L1 or CTLA-4, as well as other targeted therapies.

What prior FDA approvals exist?

The FDA has approved several treatments for Squamous Cell Carcinoma that target pathways involved in tumor growth or immune evasion. For instance, cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), has shown activity in combination with chemotherapy for head and neck squamous cell carcinoma. Additionally, immune checkpoint inhibitors like pembrolizumab, which targets PD-1, have been approved for use in squamous cell carcinoma of the head and neck, demonstrating improved overall survival in patients with high PD-L1 expression. These treatments are similar to the investigational agent INCB099280, which is being studied for its safety, tolerability, and preliminary efficacy in advanced cutaneous squamous cell carcinoma.

What other types of research exist?

Promising novel alternatives to INCB099280 for Squamous Cell Carcinoma patients include: 1) Pembrolizumab (Keytruda) - an anti-PD-1 therapy showing efficacy in various SCCs, 2) Cemiplimab (Libtayo) - another anti-PD-1 therapy specifically approved for advanced cutaneous SCC, and 3) Atezolizumab (Tecentriq) - an anti-PD-L1 therapy being explored in SCC. These agents target immune checkpoints, enhancing the body's immune response against cancer cells.

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Monoclonal Antibodies

INCB099280 for Skin Cancer

Phase 2

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 2 years

Awards & highlights

Summary

This trial is testing a new drug called INCB099280 to see if it is safe and works well for people with advanced skin cancer. The drug aims to stop the cancer cells from growing by blocking certain signals.

Who is the study for?

This trial is for adults with advanced Cutaneous Squamous Cell Carcinoma (cSCC) that can't be cured by surgery or radiotherapy. Participants should have measurable disease, an ECOG score of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and a life expectancy over three months. They must not be at risk of pregnancy or fathering children.

What is being tested?

The study tests the safety and effectiveness of INCB099280 on patients with cSCC. It aims to find out how well this drug works and what side effects it might cause when given to people who either haven't been treated before or whose cancer has returned after treatment.

What are the potential side effects?

While specific side effects for INCB099280 aren't listed, common ones for cancer treatments like this may include fatigue, nausea, skin reactions at the injection site, immune-related conditions such as inflammation in organs, potential infection risks due to lowered immunity, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with TEAEs leading to dose modification or discontinuation

Number of participants with Treatment-emergent Adverse Events (TEAEs)

Objective response rate (ORR)

Secondary study objectives

Disease Control Rate (DCR)

Duration Of Response (DOR)

INCB099280 pharmacokinetic (PK) in Plasma

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: INCB099280 Dose selected from Part 1Experimental Treatment1 Intervention

Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.

Group II: Part 1: INCB099280 Dose 3Experimental Treatment1 Intervention

Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.

Group III: Part 1: INCB099280 Dose 2Experimental Treatment1 Intervention

Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.

Group IV: Part 1: INCB099280 Dose 1Experimental Treatment1 Intervention

Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCB099280

2024

Completed Phase 1

~10

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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 Squamous Cell Carcinoma (SCC) include surgical excision, radiation therapy, and systemic therapies such as chemotherapy and immunotherapy. Immunotherapy, particularly immune checkpoint inhibitors like anti-PD-1/PD-L1 and anti-CTLA-4 antibodies, works by blocking proteins that prevent the immune system from attacking cancer cells. Small molecule inhibitors, such as those targeting the hedgehog pathway, inhibit specific proteins involved in tumor growth and survival. Understanding these mechanisms is crucial for SCC patients as it helps in selecting the most effective treatment strategy, potentially improving outcomes and minimizing side effects.

Human Papillomavirus Induced Cervical and Oropharyngeal Cancers: From Mechanisms to Potential Immuno-therapeutic Strategies.Cancer Immunotherapy: Selected Targets and Small-Molecule Modulators.Propelling Immunotherapy Combinations Into the Clinic.

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Who is running the clinical trial?

Incyte CorporationLead Sponsor

382 Previous Clinical Trials

56,989 Total Patients Enrolled

Incyte Medical MonitorStudy DirectorIncyte Corporation

31 Previous Clinical Trials

5,779 Total Patients Enrolled

Media Library

INCB099280 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05888844 — Phase 2

Squamous Cell Carcinoma Research Study Groups: Part 1: INCB099280 Dose 2, Part 1: INCB099280 Dose 1, Part 1: INCB099280 Dose 3, Part 2: INCB099280 Dose selected from Part 1

Squamous Cell Carcinoma Clinical Trial 2023: INCB099280 Highlights & Side Effects. Trial Name: NCT05888844 — Phase 2

INCB099280 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05888844 — Phase 2

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