Clinical trial NCT06720987: A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: KRAS G12C Mutation
KRAS G12S Mutation
Solid Tumor Malignancies
CRC (Colorectal Cancer)
Keywords: cetuximab
KQB365
Lead sponsor: Kumquat Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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?
* Does KQB365 alone or in combination with cetuximab decrease the size of the tumor?
* What happens to KQB365 in the body?

Participants will:

* Receive KQB365 infusion weekly alone or in combination with cetuximab
* Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Active primary central nervous system tumors
* Cardiac abnormalities
* Active interstitial lung disease

Primary outcomes:
measure: 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
measure: Recommended Phase 2 Dose (RP2D) (Part 1)
timeFrame: up to 35 months
measure: Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Part 2)
timeFrame: up to 35 months
Secondary outcomes:
measure: Concentration-time curve (AUC)
timeFrame: up to 35 months
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 35 months
measure: Time to maximum plasma concentration (tmax)
timeFrame: up to 35 months
measure: Overall survival (OS)
timeFrame: up to 35 months
measure: Progression-free survival (PFS)
timeFrame: up to 35 months
measure: Overall response rate (ORR)
timeFrame: up to 35 months
measure: Duration of response (DOR)
timeFrame: up to 35 months
measure: Time to response (TTR)
timeFrame: up to 35 months
measure: Disease control rate (DCR)
timeFrame: up to 35 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Cancer Institute at HealthONE
state: Colorado
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic, Taussig Cancer Institute
state: Ohio
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Fairfax
country: United States
facility: NEXT Virginia, LLC
state: Virginia
Study officials:
References: