Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB123667 · 7 trials · 5 indications
Defined as the time from randomization until the first documented disease progression or disease recurrence as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first.
Defined as the time from the date of randomization until death due to any cause.
Defined as having a confirmed best overall response of complete response (CR) or partial response (PR), as determined by independent review committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Defined as the maximum plasma concentration.
Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.
Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.
Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.
To characterize the metabolic profile and identify circulating and excreted metabolites of INCB123667 following administration of a single oral dose of INCB123667 followed by an oral dose solution of \[14C\]-INCB123667 using liquid chromatography with mass spectral detection.
Defined as the maximum observed plasma or serum concentration.
Defined as the time to maximum concentration.
Defined as the area under the steady-state plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A (TGA) | EXPERIMENTAL | Bevacizumab plus INCB123667 at the protocol defined dose. |
| Treatment Group B (TGB) | EXPERIMENTAL | Bevacizumab plus matching placebo at the protocol defined dose. |
| Cohort 1 | EXPERIMENTAL | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
| Cohort 2 | EXPERIMENTAL | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
| Cohort 3 | EXPERIMENTAL | INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol. |
| Group 1: Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment will be enrolled in Group 1. |
| Group 2: End Stage Renal Disease | EXPERIMENTAL | Participants with end stage renal disease will be enrolled in Group 2. |
| Cohort 1: Moderate hepatic function | EXPERIMENTAL | Participants with moderate hepatic impairment will be enrolled in Cohort 1. |
| Cohort 2: Severe hepatic function | EXPERIMENTAL | Participants with severe hepatic impairment will be enrolled in Cohort 2. |
| Treatment: INCB123667 | EXPERIMENTAL | Participants will be administered INCB123667 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667. |
| Cohort 1: Treatment A - INCB123667 Fasted | EXPERIMENTAL | INCB123667 will be administered at the protocol defined dose. |
| Cohort 1: Treatment B - INCB123667 Fed | EXPERIMENTAL | INCB123667 will be administered at the protocol defined dose. |
| Cohort 2: INCB123667 and itraconazole | EXPERIMENTAL | INCB123667 and itraconazole will be administered at protocol defined doses. |
| Cohort 3: INCB123667 and carbamazepine | EXPERIMENTAL | INCB123667 and carbamazepine will be administered at protocol defined doses. |
| Name | Type | Description |
|---|---|---|
| INCB123667 | DRUG | INCB123667 will be administered at the protocol defined dose. |
| Bevacizumab | DRUG | Bevacizumab will be administered at the protocol defined dose. |
| Placebo | DRUG | Placebo will be administered at the protocol defined dose. |
| Investigator's choice of chemotherapy | DRUG | The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol: |
| itraconazole | DRUG | Oral: Tablet |
| carbamazepine | DRUG | Oral; Tablet |
Inclusion Criteria: * Newly diagnosed, histologically confirmed, FIGO Stage III or IV, high-grade serous, high-grade endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer. * Underwent debulking surgery prior to randomization (either PDS or IDS). * Completed first-line pl...
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INCB123667 is an investigational small molecule being studied for use in healthy participants, renal impairment, hepatic insufficiency, and ovarian cancer. It is currently in Phase 1 clinical development, with trials evaluating its safety, pharmacokinetics, and effects in these populations.
INCB123667 targets CDK2, a protein involved in cell cycle regulation. By inhibiting CDK2, the drug may interfere with cancer cell proliferation. This mechanism is being explored in the context of ovarian cancer and other conditions.
INCB123667 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics.
INCB123667 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. All ongoing and completed trials are Phase 1 studies focusing on safety, pharmacokinetics, and drug interactions in healthy participants and special populations.
INCB123667 has four Phase 1 trials. Completed studies include NCT06909162, evaluating food effects and drug interactions with itraconazole and carbamazepine, and NCT07218744, a mass balance study. Recruiting trials include NCT07559396 in severe renal impairment and NCT07559474 in moderate or severe hepatic impairment.
INCB123667 is the sole name provided for this investigational drug. No alternative names or aliases have been reported in the clinical trial information. It is identified by this designation across all registered studies.