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Trial Title:
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
NCT ID:
NCT06507306
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Osimertinib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KQB198
Description:
Oral KQB198
Arm group label:
Combo Therapy Dose Escalation
Arm group label:
Combo Therapy Dose Expansion - RP2D
Arm group label:
Combo Therapy Dose Expansion - RP2D-1
Arm group label:
Combo Therapy Dose Expansion OBD
Arm group label:
Monotherapy Dose Escalation
Intervention type:
Drug
Intervention name:
osimertinib
Description:
Oral osimertinib
Arm group label:
Combo Therapy Dose Escalation
Arm group label:
Combo Therapy Dose Expansion - RP2D
Arm group label:
Combo Therapy Dose Expansion - RP2D-1
Arm group label:
Combo Therapy Dose Expansion OBD
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- PART 1: Histologically confirmed diagnosis of a solid tumor malignancy with any of
the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or
inactivating mutations of NF1.
- PART 1 (Osimertinib arm) and Part 2 Cohort A: Histologically confirmed diagnosis of
NSCLC with activating EGFR mutation and progression on osimertinib
- Part 3 Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion
EGFR mutation
- Unresectable or metastatic disease
- No available treatment with curative intent
- Adequate organ function
- Measurable disease per RECIST 1.1.
Exclusion Criteria:
- Prior therapy with a similar mechanism of action to KQB198
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or
other gastrointestinal conditions likely to alter absorption of study treatment or
result in inability to swallow
- History of interstitial lung disease
- Cardiac abnormalities
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute at HealthONE
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shelby Mosier-Murray
Email:
shelby.mosiermurray@sarahcannon.com
Facility:
Name:
Sarah Cannon Research Institute at Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ingrid Acker
Email:
Ingrid.Acker@scri.com
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mallory Hawkins
Email:
Mallory.Hawkins@flcancer.com
Facility:
Name:
The Lindner Center for Research and Education at The Christ Hospital
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abby Reed
Email:
abby.reed@thechristhospital.com
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Derrick Porter
Email:
Derrick.porter@scri.com
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jordan Georg
Email:
jgeorg@nextoncology.com
Facility:
Name:
NEXT Oncology
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Patterson
Email:
bpatterson@nextoncology.com
Start date:
June 3, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Kumquat Biosciences Inc.
Agency class:
Industry
Source:
Kumquat Biosciences Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06507306
