INCB 123667-101

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

  • Code NKI: M22NCB
  • Code firma: INCB 123667-101
  • Code clinicaltrials.gov: NCT05238922

Principal Investigator

Dr. F. Opdam

Drugs

INCB 123667: CDK2 inhibitor

  • Deel 1A (escalation): alle tumor types with CCNE1 amplification – closed
  • Deel 1B (expansion): only endometrium, gastric, TNBC and GEJ – open

Summary

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 at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 4 tumor-specific cohorts at the RDE(s) defined in Part 1A.

Read more on clinicaltrials.gov

Patient population

Tumor type: All tumor types / Endometrial cancer, endometrial carcinoma / Esophageal cancer, esophagus carcinoma / Breast cancer, breast carcinoma
Tumor subtype: gastro-esophageal junction carcinoma, GEJ cancer
Tumor characteristics: CCNE1 amplification / Other / Adenocarcinoma / HR+ Her2 positive