NCT04718675

A Study of KB-0742 in Participants With Relapsed or Refractory Solid Tumors Including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC)

Phase 1, First-in-human, Open-label Dose Escalation and Cohort Expansion Study of KB-0742 in Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin Lymphoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Kronos Bio · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Part 1: Dose Escalation. The primary objective of Part 1 of this study is to evaluate the safety and tolerability of KB-0742 in participants with relapsed or refractory (R/R) solid tumors or non-Hodgkin lymphoma (NHL). Part 2: Cohort Expansion. The primary objective of Part 2 of this study is to further evaluate the safety and tolerability of KB-0742 in defined participant cohorts including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC).

Detailed description

Part 2 cohort expansion is now enrolling Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC) patients who may have one or more of these genetic alterations, BRCA 1 mutation, BRCA 2 mutation, MYC amplification/ overexpression, Homologous Recombination Deficient (HRD) positive.

Conditions

• Relapsed Solid Tumors
• Refractory Solid Tumors
• Non-Hodgkin Lymphoma
• HGSOC
• Platinum Resistant High Grade Serous Ovarian Cancer

Interventions

Type	Name	Description
DRUG	KB-0742	Oral capsules

Timeline

• Start date: 2021-02-08
• Primary completion: 2025-01-07
• Completion: 2025-02-07
• First posted: 2021-01-22
• Last updated: 2025-02-17

Locations

24 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study