A Study to Investigate the Safety and Efficacy of KQB365 As Monotherapy and in Combination in Participants with Advanced Solid Malignancies
- Conditions
- Interventions
- Registration Number
- NCT06720987
- Lead Sponsor
- Kumquat Biosciences Inc.
- 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 or in combination with cetuximab?
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 128
- PART 1 (monotherapy): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (combo therapy) & 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
- Active primary central nervous system tumors
- Cardiac abnormalities
- Active interstitial lung disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy Dose Expansion - RP2D-1 KQB365 Drug: KQB365 - Intravenous KQB365 Combo Therapy Dose Expansion - RP2D KQB365 Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab Combo Therapy Dose Expansion - RP2D Cetuximab Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab Combo Therapy Dose Expansion - RP2D-1 KQB365 Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab Combo Therapy Dose Expansion - RP2D-1 Cetuximab Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab Monotherapy Dose Expansion - RP2D KQB365 Drug: KQB365 - Intravenous KQB365 Monotherapy Dose Escalation KQB365 Drug: KQB365 - Intravenous KQB365 Combo Therapy Dose Escalation KQB365 Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab Combo Therapy Dose Escalation Cetuximab Drug: KQB365 - Intravenous KQB365 Drug: - Intravenous cetuximab
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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