A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Incyte

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: INCB123667

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT07023627

INCB123667-203

2025-521513-14-00 (Registry Identifier)

GOG-3129/INCB123667-203 (Other Identifier)

Details and patient eligibility

About

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

• Have platinum-resistant disease:

  • Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen.
  • Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.

• Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.

• Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.

• Must have received bevacizumab unless there was a contraindication for its use.

• If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.

Exclusion criteria

• Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
• Have primary platinum-refractory disease: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.
• The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
• Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
• Known active CNS metastases and/or carcinomatous meningitis.
• Known additional malignancy that is progressing or requires active treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

Cohort 1

Experimental group

Description:

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Treatment:

Drug: INCB123667

Cohort 2

Experimental group

Description:

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Treatment:

Drug: INCB123667

Cohort 3

Experimental group

Description:

INCB123667 will be administered at the protocol defined dose based on their tumor cyclin E1 expression levels as defined in the protocol.

Treatment:

Drug: INCB123667