> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-safety-and-efficacy-of-kqb365-as-b18a7488-79e7-4055-b13d-764030b36a9b > Record changed: 2026-11-04 # A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies NCT06720987 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) Participants 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) Lead sponsor Kumquat Biosciences Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) Start date 2025-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Short title** A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Dates **Completion date** 2030-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **First posted** 2024-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Registry last updated** 2026-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Primary completion date** 2029-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Start date** 2025-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Size and sites **Participants** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Planned participants** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Lead sponsor** Kumquat Biosciences Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Identifiers **Registry ID** NCT06720987 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **ClinicalTrials.gov ID** NCT06720987 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Outcomes ### Primary outcomes 1. Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) Timeframe: 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. 2. Recommended Phase 2 Dose (RP2D) (Part 1) Timeframe: up to 35 months Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D. 3. Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2) Timeframe: 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 outcomes 1. Concentration-time curve (AUC) Timeframe: up to 35 months 2. Maximum plasma concentration (Cmax) Timeframe: up to 35 months 3. Time to maximum plasma concentration (tmax) Timeframe: up to 35 months 4. Overall survival (OS) Timeframe: up to 35 months 5. Progression-free survival (PFS) Timeframe: up to 35 months using RECIST v1.1 6. Overall response rate (ORR) Timeframe: up to 35 months using RECIST v1.1 7. Duration of response (DOR) Timeframe: up to 35 months using RECIST v1.1 8. Time to response (TTR) Timeframe: up to 35 months using RECIST v1.1 9. Disease control rate (DCR) Timeframe: up to 35 months using RECIST v1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Sites - Mayo Clinic, PhoenixPhoenix, United StatesRecruiting - Sarah Cannon Cancer Institute at HealthONEDenver, United StatesRecruiting - Mayo Clinic, JacksonvilleJacksonville, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - START MidwestGrand Rapids, United StatesRecruiting - Mayo Clinic, RochesterRochester, United StatesRecruiting - Cleveland Clinic, Taussig Cancer InstituteCleveland, United StatesRecruiting - OU Health Stephenson Cancer CenterOklahoma City, United StatesRecruiting - Sydney Kimmel Cancer CenterPhiladelphia, United StatesRecruiting - NEXT OncologySan Antonio, United StatesRecruiting - NEXT Virginia, LLCFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06720987) ## Related records ### Drugs (1) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) ### Lead sponsors (1) - [Kumquat Biosciences Inc.](https://trialight.com/data/company/kumquat-biosciences-inc-e157a0da-3bd2-489b-9acd-980b7f32c55f.md) ### Conditions (3) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) ### Targets (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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