Advanced Solid Tumors, Colorectal Cancer (CRC), KRAS G12C Mutations, KRAS G12S Mutations, Non-Small Cell Lung Cancer, Uterine Cancer
Conditions
Keywords
KQB368
Brief summary
The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are: * What is the safe dose of KQB368 as a monotherapy? * Does KQB368 decrease the size of the tumor? * What happens to KQB368 in the body? Participants will: * Take KQB368 orally daily in 21-day cycles * Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
Interventions
DRUGKQB368
Oral KQB368
Sponsors
Kumquat Biosciences Inc.
Worldwide Clinical Trials
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of a solid tumor * Malignancy 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 * Must be able to swallow with no GI condition that prevents absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | Up to 44 months | Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 44 months | Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria (RECISTv1.1). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from first dose of study treatment until last dose. |
| Overall survival (OS) | Up to 44 months | Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death. |
| Duration of response (DOR) | Up to 44 months | Duration of response is defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first. |
| Time to response (TTR) | Up to 44 months | Time to response is defined as time from first dose of study treatment to date of first documentation of objective tumor response (CR or PR) based on RECIST v1.1. |
| Disease control rate (DCR) | Up to 44 months | Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from first dose of study treatment until last dose. |
| Progression-free survival (PFS) | Up to 44 months | Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first. |
| Area under the concentration-time curve (AUC) | Up to 44 months | — |
| Maximum plasma concentration (Cmax) | Up to 44 months | — |
| Time to maximum plasma concentration (tmax) | Up to 44 months | — |
Contacts
CONTACTKumquat Clinical Development Telephone
Outcome results
None listed