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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 belowSelect...
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:Select...
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.
Select...
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
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 moreSecondary study objectives
Disease Control Response (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)
+7 moreAwards & 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.
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.
Current trends and future directions in the genetic therapy of human neoplastic disease.
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
391 Previous Clinical Trials
63,495 Total Patients Enrolled
Liz Croft RichardsStudy DirectorIncyte Corporation
Kevin O'Hayer, MDStudy DirectorIncyte Corporation
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that are not allowed in the study.I have no other cancer needing treatment or that has been active in the last 2 years, except for certain skin cancers or other minor cancers treated over a year ago.My condition worsened after standard treatment, or I can't tolerate/have no other treatment options.I have been diagnosed with HIV.I am between 18 and 99 years old, living in France.I do not have severe liver disease or serious stomach/intestine problems.I am not on long-term antibiotics or antivirals for an infection.I am not currently on, nor have I recently taken, any experimental drugs.I have or had hepatitis B or C, but it's under control or cleared.I have not had major surgery in the last 28 days.I currently have or might have COVID-19.I am not pregnant or breastfeeding.I am currently on treatment for a chronic or active infection.I am fully active or can carry out light work.My cancer can be measured by scans but cannot be removed by surgery.I am not currently on, nor have I recently taken, strong medications that affect liver enzymes.I have untreated or worsening brain metastases.I haven't had radiation therapy in the last 28 days.I do not have serious heart conditions or uncontrolled high blood pressure.I haven't changed my hormone therapy or taken targeted cancer treatments recently.I have been treated with a CDK2 inhibitor before.I still have side effects from previous treatments or surgeries that are not mild.I can provide a sample of my tumor or am willing to have a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Dose Expansion Cohort Disease Group 4
- Group 2: Phase 1b: Dose Expansion Cohort Disease Group 5
- Group 3: Phase 1b: Dose Expansion Cohort Disease Group 6
- Group 4: Phase 1b: Dose Expansion Cohort Disease Group 1
- Group 5: Phase 1b: Dose Expansion Cohort Disease Group 2
- Group 6: Phase 1b: Dose Expansion Cohort Disease Group 3
- Group 7: Phase 1a Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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