CRC (Colorectal Cancer), KRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies
Conditions
Keywords
cetuximab, KQB365, KQB198
Brief 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, 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.
Interventions
Sponsors
Kumquat Biosciences Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) | From enrollment to the end of treatment | 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. |
| Recommended Phase 2 Dose (RP2D) (Part 1) | up to 35 months | Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D. |
| Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2) | up to 35 months | ORR 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 1st dose of study treatment until last dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration-time curve (AUC) | up to 35 months | — |
| Maximum plasma concentration (Cmax) | up to 35 months | — |
| Time to maximum plasma concentration (tmax) | up to 35 months | — |
| Overall survival (OS) | up to 35 months | — |
| Progression-free survival (PFS) | up to 35 months | using RECIST v1.1 |
| Overall response rate (ORR) | up to 35 months | using RECIST v1.1 |
| Duration of response (DOR) | up to 35 months | using RECIST v1.1 |
| Time to response (TTR) | up to 35 months | using RECIST v1.1 |
| Disease control rate (DCR) | up to 35 months | using RECIST v1.1 |
Countries
United States
Contacts
CONTACTKumquat Clinical Development
Outcome results
None listed