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Recruiting Phase 1 NCT06720987

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Phase 1 – testing safety in a small group of people
Conditions: KRAS G12C Mutation KRAS G12S Mutation Solid Tumor Malignancies CRC (Colorectal Cancer)

Sponsor: Kumquat Biosciences Inc.

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Overview
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, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.
Who can participate
Inclusion Criteria: * PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation. * PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation. * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST v1.1 Exclusion Criteria: * Active primary central nervous system tumors * Cardiac abnormalities * Active interstitial lung disease * Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Interventions
KQB365
DRUG
Cetuximab
DRUG
KQB198
DRUG
Locations 11
United States (11)
Dana Farber Cancer Institute
Boston , Massachusetts
Cleveland Clinic, Taussig Cancer Institute
Cleveland , Ohio
Sarah Cannon Cancer Institute at HealthONE
Denver , Colorado
NEXT Virginia, LLC
Fairfax , Virginia
START Midwest
Grand Rapids , Michigan
Mayo Clinic, Jacksonville
Jacksonville , Florida
OU Health Stephenson Cancer Center
Oklahoma City , Oklahoma
Sydney Kimmel Cancer Center
Philadelphia , Pennsylvania
Mayo Clinic, Phoenix
Phoenix , Arizona
Mayo Clinic, Rochester
Rochester , Minnesota
NEXT Oncology
San Antonio , Texas
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.02.2025
Completion date
30.06.2030
Registry ID
NCT06720987
Source
clinicaltrials.gov
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