NCT06507306

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kumquat Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are: * What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs? * Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor? * What happens to KQB198 in the body? Participants will: * Take KQB198 daily, alone or in combination with another anti-cancer drug * Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	KQB198	Oral KQB198
DRUG	Osimertinib	Oral Osimertinib
DRUG	Amivantamab	Subcutaneous administration

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-07-31
• Completion: 2027-01-31
• First posted: 2024-07-18
• Last updated: 2026-02-06

Locations

35 sites across 6 countries: United States, France, Italy, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study