What side effects are associated with this type of intervention?

Common treatments for advanced or metastatic solid tumors, including investigational drugs like INCA33890, often result in side effects such as fatigue, nausea, vomiting, diarrhea, decreased appetite, and myelosuppression (anemia, neutropenia, thrombocytopenia). Targeted therapies may cause hypertension, hand-foot syndrome, and liver toxicity, while immunotherapies can lead to immune-related adverse events like colitis, dermatitis, hepatitis, and endocrinopathies.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of advanced or metastatic solid tumors. Notable examples include pembrolizumab and nivolumab, which target the PD-1 pathway, and ipilimumab, which targets CTLA-4. These drugs have shown efficacy in various solid tumors, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, combination therapies such as nivolumab plus ipilimumab have been approved for enhanced efficacy in certain cancers. These approvals are based on their ability to improve overall survival and progression-free survival in patients with advanced stages of solid tumors.

What other types of research exist?

Promising alternatives to INCA33890 for advanced or metastatic solid tumors include: <ol> <li>NVP-AUY922: An HSP90 inhibitor showing significant reduction in tumor uptake in ovarian cancer models.</li> <li></li> </ol> Regorafenib: Demonstrated efficacy and safety in metastatic osteosarcoma in phase II studies. 3. Cabozantinib: Evaluated in advanced Ewing sarcoma or osteosarcoma with promising results. 4. Olaparib: Shown to prolong progression-free survival in metastatic castration-resistant prostate cancer. 5. Pazopanib: Evaluated for unresectable or metastatic chondrosarcoma with noted antitumor activity.

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INCA33890 for Metastatic 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 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called INCA33890 to see if it is safe and how well patients can tolerate it. The study focuses on people with advanced or metastatic solid tumors, which are cancers that have spread and are hard to treat. Researchers aim to find the highest dose that can be given without causing serious side effects.

Who is the study for?

Adults with certain advanced or metastatic solid tumors who've had disease progression after standard treatments, including immunotherapies if applicable. They must have a good performance status, measurable disease, and be willing to undergo tumor biopsies. Exclusions include significant medical conditions, more than four prior cancer treatments for advanced disease, active infections or hepatitis/HIV, recent anticoagulation therapy changes.

What is being tested?

The trial is testing the safety of a new drug called INCA33890 in patients with specific types of solid tumors. It aims to find the maximum tolerated dose and optimal dosing schedule by observing any dose-limiting toxicities that occur during treatment.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects for drugs like INCA33890 may include fatigue, nausea, diarrhea, skin reactions at injection sites and potential immune-related issues such as inflammation in various organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 1b-Dose ExpansionExperimental Treatment1 Intervention

INCA33890 will be administered at the recommended dose(s) for expansion (RDE\[s\]) in participants with advanced or metastatic ICI sensitive or ICI non sensitive tumor types

Group II: Part 1a - Dose EscalationExperimental Treatment1 Intervention

INCA33890 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 treatments for solid tumors include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as those targeting HER2 or VEGF, disrupt specific molecules involved in tumor growth and progression. Immunotherapies, like PD-1 or PD-L1 inhibitors, boost the immune system's ability to fight cancer. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. These mechanisms are important for patients to understand as they help in choosing the most effective treatment based on the tumor's characteristics and the patient's health.

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