What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often result in side effects such as neutropenia, fatigue, neuropathy, diarrhea, and nausea. Specific drugs like gemcitabine and nab-paclitaxel are known to cause these side effects. Immune checkpoint inhibitors, such as pembrolizumab, can also lead to adverse events like pneumonitis and rash. Investigational therapies, including ONC201, may have unique side effects that are still being studied.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, particularly focusing on immune checkpoint inhibitors and targeted therapies. Pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for various solid tumors, including melanoma and non-small cell lung cancer. Ipilimumab, a CTLA-4 inhibitor, is also approved for melanoma. Additionally, combination therapies such as nivolumab with ipilimumab have shown efficacy in treating advanced renal cell carcinoma. These approvals highlight the trend towards using immunotherapy and targeted treatments in managing solid tumors.

What other types of research exist?

Promising alternatives to INCB123667 for solid tumor patients include: 1) Pembrolizumab, an anti-PD-1 monoclonal antibody, which has shown efficacy in various solid tumors. 2) Atezolizumab, an anti-PD-L1 antibody, used in combination with chemotherapy for non-small cell lung cancer. 3) Entrectinib, a ROS1 and NTRK inhibitor, effective in ROS1 fusion-positive non-small cell lung cancer. 4) Lenvatinib, a multi-kinase inhibitor, used in combination with pembrolizumab for advanced endometrial cancer. These therapies have demonstrated significant clinical activity and safety in recent trials.

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INCB0123667 for Solid Tumors

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

ECOG performance status score of 0 or 1

Measurable lesions by CT or MRI based on RECIST v1.1 criteria that are considered nonamenable to surgery or other curative treatments or procedures

Must not have

Current use of certain prohibited medications

Known history of HIV (HIV 1/2 antibodies)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called INCB123667 to see if it can help treat advanced or spreading cancers. It aims to find out how safe and effective the drug is, and how the body processes it. The study focuses on patients whose cancers are advanced or have spread.

Who is the study for?

This trial is for adults with advanced solid tumors, including specific types such as gynecologic, gastrointestinal, and breast cancers. Participants must have a performance status indicating they are relatively active and capable of self-care. They should have measurable lesions not suitable for curative treatments and be willing to provide tumor specimens. Pregnant or breastfeeding individuals cannot join, nor can those with certain heart conditions, uncontrolled diseases, recent other cancer treatments or surgeries.

What is being tested?

The study tests INCB123667's safety and effectiveness in treating advanced solid tumors. It has two parts: dose escalation to find the maximum tolerated dose (MTD) and recommended dose for expansion (RDE), followed by a cohort expansion phase at the RDE to assess antitumor activity across six different tumor-specific groups.

What are the potential side effects?

While specific side effects aren't listed here, common ones in trials like this may include fatigue, nausea, diarrhea, skin reactions at injection sites if applicable, allergic reactions to the drug components themselves or increased susceptibility to infections due to immune system impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer can be measured by scans but cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medications that are not allowed in the study.

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I have been diagnosed with HIV.

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I do not have severe liver disease or serious stomach/intestine problems.

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I am not on long-term antibiotics or antivirals for an infection.

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I currently have or might have COVID-19.

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I am not pregnant or breastfeeding.

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I am currently on treatment for a chronic or active infection.

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I am not currently on, nor have I recently taken, strong medications that affect liver enzymes.

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I have untreated or worsening brain metastases.

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I do not have serious heart conditions or uncontrolled high blood pressure.

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I haven't changed my hormone therapy or taken targeted cancer treatments recently.

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I have been treated with a CDK2 inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Number of Participants Discontinue study due to TEAE

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Number of Participants who Undergo Dose Reductions due to TEAE

+2 more

Secondary study objectives

Disease Control Response (DCR)

Duration of Response (DOR)

Objective Response Rate (ORR)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Phase 1b: Dose Expansion Cohort Disease Group 6Experimental Treatment1 Intervention

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with other tumor indications with CCNE1 amplification or cyclin E1 over-expression will enroll in this group.

Group II: Phase 1b: Dose Expansion Cohort Disease Group 5Experimental Treatment1 Intervention

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with HR+/HER2- breast cancer who have had disease progression on or been intolerant of a CDK4/6 inhibitor will enroll in this group.

Group III: Phase 1b: Dose Expansion Cohort Disease Group 4Experimental Treatment1 Intervention

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Triple Negative Breast Cancer(TNBC) will enroll in this group.

Group IV: Phase 1b: Dose Expansion Cohort Disease Group 3Experimental Treatment1 Intervention

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gastric, Gastro Esophageal Junction (GEJ), and esophageal adenocarcinomas will enroll in this group.

Group V: Phase 1b: Dose Expansion Cohort Disease Group 2Experimental Treatment1 Intervention

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Endometrial/Uterine cancer will enroll in this group.

Group VI: Phase 1b: Dose Expansion Cohort Disease Group 1Experimental Treatment1 Intervention

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma ) will enroll in this group.

Group VII: Phase 1a Dose EscalationExperimental Treatment1 Intervention

INCB123667 will be administered at a protocol defined starting regimen once daily (QD) orally in 28-day cycles. Subsequent dose regimens will be determined during study conduct.

0 / 14Eligibility criteria met

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 chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect normal cells, leading to side effects. Immunotherapy, such as checkpoint inhibitors, enhances the body's immune response against cancer cells by blocking proteins that suppress immune activity. Targeted therapies, including those that inhibit specific mutations or pathways (e.g., BRAF inhibitors in melanoma), directly interfere with molecular targets involved in tumor growth and survival. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment, managing expectations regarding efficacy and side effects, and exploring new investigational therapies like INCB123667 that may offer more personalized and effective options.

Current trends and future directions in the genetic therapy of human neoplastic disease.