Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as INCB0123667
INCB123667 · 6 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.
Toxicities occurring during the first treatment cycle, Part 1a, will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Participants will receive dose reductions of INCB123667 according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.
Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.
TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| 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. |
| Phase 1a Dose Escalation | EXPERIMENTAL | 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. |
| Phase 1b: Dose Expansion Cohort Disease Group 1 | EXPERIMENTAL | 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. |
| Phase 1b: Dose Expansion Cohort Disease Group 2 | EXPERIMENTAL | 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. |
| Phase 1b: Dose Expansion Cohort Disease Group 3 | EXPERIMENTAL | 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. |
| Phase 1b: Dose Expansion Cohort Disease Group 4 | EXPERIMENTAL | 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. |
| Phase 1b: Dose Expansion Cohort Disease Group 5 | EXPERIMENTAL | 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. |
| Phase 1b: Dose Expansion Cohort Disease Group 6 | EXPERIMENTAL | INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors will enroll in this group. |
| Phase 2a Dose Escalation Treatment Group A (TGA) | EXPERIMENTAL | INCB123667 administered in combination with palbociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group B (TGB) | EXPERIMENTAL | INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group C (TGC) | EXPERIMENTAL | INCB123667 administered in combination with ribociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group D (TGD) | EXPERIMENTAL | INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group E (TGE) | EXPERIMENTAL | INCB123667 administered in combination with bevacizumab at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group F (TGF) | EXPERIMENTAL | INCB123667 administered in combination with olaparib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group G (TGG) | EXPERIMENTAL | INCB123667 administered in combination with paclitaxel at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group H (TGH) | EXPERIMENTAL | INCB123667 administered in combination with palbociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group I (TGI) | EXPERIMENTAL | INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol |
| Phase 2b Dose Expansion Treatment Group J (TGJ) | EXPERIMENTAL | INCB123667 administered in combination with ribociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group K (TGK) | EXPERIMENTAL | INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group L (TGL) | EXPERIMENTAL | INCB123667 administered in combination with bevacizumab at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol. |
| Phase 2b Dose Expansion Treatment Group M (TGM) | EXPERIMENTAL | INCB123667 administered in combination with olaparib at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol. |
| Phase 2b Dose Expansion Treatment Group N (TGN) | EXPERIMENTAL | INCB123667 administered in combination with weekly paclitaxel at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol. |
| 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: |
| INCB0123667 | DRUG | 25 mg tablets |
| Palbociclib | DRUG | Palbociclib will be administered at protocol defined dose. |
| Olaparib | DRUG | Olaparib will be administered at protocol defined dose. |
| Paclitaxel | DRUG | Paclitaxel will be administered at protocol defined dose. |
| Ribociclib | DRUG | Ribociclib will be administered at protocol defined dose. |
| Fulvestrant | DRUG | Fulvestrant will be administered at protocol defined dose. |
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 oral small molecule developed by Incyte Corporation. It is being studied in ovarian cancer and in participants with hepatic or renal impairment. Incyte is running Phase 1 pharmacokinetic studies in organ impairment and Phase 3 studies in ovarian cancer, including platinum-resistant disease and first-line maintenance.
INCB123667 is being studied in ovarian cancer, including platinum-resistant ovarian cancer with cyclin E1 overexpression and as first-line maintenance therapy in ovarian cancer overexpressing cyclin E1. It is investigational and has not been approved for any indication. The ovarian cancer programs include two Phase 3 trials.
INCB123667 targets CDK2, a protein involved in cell cycle regulation. CDK2 is a cyclin-dependent kinase, and the clinical program selects for cyclin E1 overexpression, which is a partner of CDK2. Incyte is evaluating the CDK2 inhibitor both as monotherapy versus chemotherapy and in combination with bevacizumab.
Incyte Corporation, which trades on Nasdaq under the ticker INCY, is developing INCB123667. Incyte is the sponsor of the Phase 1 organ impairment studies and the Phase 3 ovarian cancer studies of the CDK2 inhibitor.
INCB123667 is in Phase 1 and Phase 3 clinical development. The Phase 1 studies evaluate pharmacokinetics in hepatic and renal impairment, while two Phase 3 studies evaluate it in ovarian cancer. INCB123667 is investigational and is not FDA approved.
INCB123667 is being evaluated in NCT07797283, a Phase 3 first-line maintenance study in ovarian cancer with bevacizumab; NCT07214779, a Phase 3 study versus investigator's choice chemotherapy in platinum-resistant ovarian cancer; NCT07559474, a Phase 1 hepatic impairment study; and NCT07559396, a Phase 1 renal impairment study.
Yes, INCB0123667 is an alternative name for INCB123667, the CDK2-targeted small molecule developed by Incyte Corporation. Both names refer to the same investigational compound being studied in ovarian cancer and in hepatic and renal impairment.