Trials / Recruiting
RecruitingNCT06720987
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (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 KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself or in combination with cetuximab? * Does KQB365 alone or in combination with cetuximab decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone or in combination with cetuximab * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KQB365 | Intravenous KQB365 |
| DRUG | Cetuximab | Intravenous cetuximab |
Timeline
- Start date
- 2025-02-04
- Primary completion
- 2029-06-30
- Completion
- 2030-06-30
- First posted
- 2024-12-06
- Last updated
- 2025-07-11
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06720987. Inclusion in this directory is not an endorsement.