A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors - INCB 123667-101

Incyte Corporation0 sites15 target enrollmentStarted: TBDLast updated: June 18, 2024

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: Incyte Corporation
Enrollment: 15

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional

Eligibility Criteria

Ages: 18 to 99 (—)

Inclusion Criteria

•1. Ability to comprehend and willingness to sign a written ICF for the study.
•2. Adults age 18 years or older at the time of signing the ICF. In France,
•adult (age of at least 18 and up to 99 years) male or female participants.
•3. Willing and able to conform to and comply with all Protocol requirements,
•including all scheduled visits and Protocol procedures.
•4. Life expectancy greater than 12 weeks.
•5. ECOG performance status score of 0 or 1.
•6. Disease progression on prior standard treatment, intolerance to or
•ineligibility for standard treatment, or no available treatment to improve the
•disease outcome.
•7. Availability of a baseline archival tumor specimen or willingness to undergo
•a pretreatment and an on-treatment tumor biopsy (core or excisional) as
•applicable to obtain the specimen.
•For participants in Part 1a and Part 1b: Fresh pretreatment biopsy (within
•the screening/prescreening period) or archival tissue (collected within 2 years
•prior to C1D1) is required as described in the protocol and in the Laboratory
•For participants in Part 1b only: At least 5 participants per disease group
•will be required to provide an on-treatment tumor biopsy during the
•third/fourth week of study drug treatment (to obtain paired biopsies).
•8. Diagnoses as follows:
•a. For participants in Part 1a (dose escalation): Histologically or
•cytologically confirmed advanced or metastatic solid tumors. Documented CCNE1
•amplification from a qualified local laboratory test is preferred but not
•b. For participants in Part 1b (dose expansion): Tumor tissue with CCNE1
•amplification as determined by a qualified local laboratory or central
•confirmation of cyclin E1 overexpression as follows (this does not apply to
•participants in disease group 5):
•* Participants with documentation of CCNE1 amplification obtained from a
•qualified local laboratory will be enrolled without central cyclin E1
•overexpression prescreening but are still required to provide a tumor tissue
•sample (fresh sample or archival tissue) for retrospective central cyclin E1
•overexpression evaluation.
•* Participants without documentation of CCNE1 amplification obtained from a
•qualified local laboratory will provide a tumor tissue sample (a fresh sample
•if archival tissue within 2 years prior to C1D1 is not available) for
•prospective central cyclin E1 overexpression evaluation as part of eligibility
•prescreening. Only participants with cyclin E1 overexpression confirmed at a
•central laboratory using a CLIA assay will be allowed to enter the study. These
•participants will be required to sign a specific prescreening consent form
•before the prescreening tumor tissue is obtained; however, no other protocol
•assessments will be performed under the prescreening consent.
•and with any of the following histologically or cytologically confirmed
•indications:
•- Gynecologic malignancies
•o Disease Group 1 (ovarian/fallopian/primary peritoneal cancer): Participants
•with advanced platinum-based chemotherapy-refractory or - resistant epithelial
•ovarian/fallopian/primary peritoneal carcinoma or clear cell ovarian cancer who
•have received up to 4 prior lines of systemic therapy administered for advanced
•or metastatic disease
•o Disease Group 2 (endometrial/uterine cancer): Participants with advan

Exclusion Criteria

•1. History of clinically significant or uncontrolled cardiac disease, including
•recent (within the last 12 months) unstable angina pectoris or acute myocardial
•infarction, or New York Heart Association Class III or IV cardiac disease,
•including preexisting clinically significant ventricular arrhythmia, congestive
•heart failure, cardiomyopathy not controlled by medication, or other clinically
•significant heart disease (ie, >= uncontrolled Grade 3 hypertension).
•Participants with a pacemaker and well-controlled rhythm for at least 1 month
•before the first dose of study drug will be allowed.
•2. History or presence of an ECG abnormality that, in the investigator's
•opinion, is clinically meaningful. Screening QTcF interval >450 milliseconds is
•excluded; in the event that a single QTc is >450 milliseconds, the participant
•may enroll if the average QTc for the 3 ECGs is <450 milliseconds.
•3. Presence of chronic or current active infectious disease requiring systemic
•antibiotic, antifungal, or antiviral treatment. Participants with acute
•infection requiring antibiotic, antifungal, or antiviral treatment should delay
•screening/enrollment until the course of antibiotic, antifungal, or antiviral
•therapy has been completed and the infection is no longer active.
•4. Untreated brain or CNS metastases or brain or CNS metastases that have
•progressed (eg, evidence of new or enlarging brain metastasis or new
•neurological symptoms attributable to brain or CNS metastases).
•Note: Participants who have previously treated and clinically stable brain or
•CNS metastases (without evidence of progression by imaging for at least 4 weeks
•before the first dose of study drug and any neurologic symptoms have returned
•to baseline), have no evidence of new or enlarging brain metastasis or CNS
•edema, and have not required steroids for at least 7 days before study drug are
•5. Known additional malignancy that is progressing or requires active
•treatment, or history of other malignancy within 2 years of the first dose of
•study drug with the exception of cured basal cell or squamous cell carcinoma of
•the skin, superficial bladder cancer, prostate intraepithelial neoplasm,
•carcinoma in situ of the cervix, or other noninvasive or indolent malignancy,
•or cancers from which the participant has been disease-free for >1 year after
•treatment with curative intent.
•6. Participants with laboratory values at screening defined in the protocol.
•7. Significant concurrent, uncontrolled medical condition, including but not
•limited to the following:
•* Known history of drug-induced liver injury; alcoholic liver disease;
•nonalcoholic steatohepatitis; primary biliary cirrhosis; ongoing extrahepatic
•obstruction caused by stones, cirrhosis of the liver, or portal hypertension.
•b. Gastrointestinal
•* Significant gastrointestinal disorder that could interfere with absorption,
•metabolism, or excretion of study drug, including gastrectomy, partial
•gastrectomy, or presence of a venting gastric tube that may interfere with
•absorption of the study drug.
•* Recent (<= 3 months) history or ongoing partial or complete bowel obstruction,
•unless corrected by surgery.
•* Any concomitant condition of the upper gastrointestinal tract that precludes
•administration of oral medications.
•8. Has not recovered to <= Grad

Investigators

Sponsor

Incyte Corporation

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