Study of INCB123667 in Subjects With Advanced Solid Tumors

Conditions

• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• INCB0123667 — DRUG
  25 mg tablets
• Palbociclib — DRUG
  Palbociclib will be administered at protocol defined dose.
• Bevacizumab — DRUG
  Bevacizumab 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.

Study Details

This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).

Key Dates

Start date

Jul 5, 2022

Status verified

Apr 2026

Primary completion

Jul 27, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

604 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a Dose Escalation
  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.
• Experimental: Phase 1b: Dose Expansion Cohort Disease Group 1
  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.
• Experimental: Phase 1b: Dose Expansion Cohort Disease Group 2
  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.
• Experimental: Phase 1b: Dose Expansion Cohort Disease Group 3
  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.
• Experimental: Phase 1b: Dose Expansion Cohort Disease Group 4
  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.
• Experimental: Phase 1b: Dose Expansion Cohort Disease Group 5
  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.
• Experimental: Phase 1b: Dose Expansion Cohort Disease Group 6
  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.
• Experimental: Phase 2a Dose Escalation Treatment Group A (TGA)
  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.
• Experimental: Phase 2a Dose Escalation Treatment Group B (TGB)
  INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol.
• Experimental: Phase 2a Dose Escalation Treatment Group C (TGC)
  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.
• Experimental: Phase 2a Dose Escalation Treatment Group D (TGD)
  INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol.
• Experimental: Phase 2a Dose Escalation Treatment Group E (TGE)
  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.
• Experimental: Phase 2a Dose Escalation Treatment Group F (TGF)
  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.
• Experimental: Phase 2a Dose Escalation Treatment Group G (TGG)
  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.
• Experimental: Phase 2b Dose Expansion Treatment Group H (TGH)
  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.
• Experimental: Phase 2b Dose Expansion Treatment Group I (TGI)
  INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol
• Experimental: Phase 2b Dose Expansion Treatment Group J (TGJ)
  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.
• Experimental: Phase 2b Dose Expansion Treatment Group K (TGK)
  INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol.
• Experimental: Phase 2b Dose Expansion Treatment Group L (TGL)
  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.
• Experimental: Phase 2b Dose Expansion Treatment Group M (TGM)
  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.
• Experimental: Phase 2b Dose Expansion Treatment Group N (TGN)
  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.

Primary Outcome Measure

Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 ]

Central Contacts

• Incyte Corporation Call Center (US)
  1.855.463.3463
  [email protected]
• Incyte Corporation Call Center (ex-US)
  +800 00027423
  [email protected]

Locations (19)

Find similar trials in Duarte, CA

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