Clinical trial NCT06507306: A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: Kumquat Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 100
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 KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:

* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
* Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
* What happens to KQB198 in the body?

Participants will:

* Take KQB198 daily, alone or in combination with another anti-cancer drug
* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that


Eligibility criteria: Inclusion Criteria:

* PART 1: Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1.
* PART 1 (Osimertinib arm) and Part 2 Cohort A: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib
* Part 3 Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST 1.1.

Exclusion Criteria:

* Prior therapy with a similar mechanism of action to KQB198
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* History of interstitial lung disease
* Cardiac abnormalities

Primary outcomes:
measure: Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
timeFrame: 28 Days
measure: Recommended Phase 2 Dose (RP2D) (Part 1)
timeFrame: up to 30 months
measure: Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)
timeFrame: up to 30 months
Secondary outcomes:
measure: Concentration-time curve (AUC)
timeFrame: up to 30 months
measure: Maximum plasma concentration (Cmax)
timeFrame: up to 30 months
measure: Time to maximum plasma concentration (tmax)
timeFrame: up to 30 months
measure: Overall survival (OS)
timeFrame: up to 30 months
measure: Progression-free survival (PFS)
timeFrame: up to 30 months
measure: Overall response rate (ORR)
timeFrame: up to 30 months
measure: Duration of response (DOR)
timeFrame: up to 30 months
measure: Time to response (TTR)
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: Orlando
country: United States
facility: Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists - Sarasota
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Long Island City
country: United States
facility: David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Nashville
country: United States
facility: Sarah Cannon and HCA Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: New Experimental Therapeutics of San Antonio - NEXT Oncology
state: Texas
city: Fairfax
country: United States
facility: New Experimental Therapeutics of Virginia - NEXT Oncology
state: Virginia
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du-Rhône
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de l'Ouest - site St-Herblain
state: Loire-Atlantique
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Saint-Andre
state: Nouvelle-Aquitane
city: Toulouse
country: France
facility: IUCT-Oncopole
state: Occitaine
city: Nantes
country: France
facility: CHU de Nantes - Hopital Nord Laennec
state: Pays De La Loire
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
state: Lazio
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus Barcelona
state: Catalonia
city: Barcelona
country: Spain
facility: New Experimental Therapeutics (NEXT) Oncology Barcelona
city: Barcelona
country: Spain
facility: South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
city: Madrid
country: Spain
facility: New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid
city: Madrid
country: Spain
facility: South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
city: Malaga
country: Spain
facility: Hospital Quirónsalud Málaga
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona
city: Liuying
country: Taiwan
facility: Chi-Mei Hospital - Liouying Branch
state: Tainan City
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Taipei City
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: