RECRUITING

A Study to Investigate the Safety and Efficacy of KQB198 As Monotherapy and in Combination in Participants with Advanced Solid Malignancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-06-03
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06507306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * PART 1 (Osimertinib arm) and Part 2 Cohort A: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib
  3. * Part 3 Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
  4. * Unresectable or metastatic disease
  5. * No available treatment with curative intent
  6. * Adequate organ function
  7. * Measurable disease per RECIST 1.1.
  1. * Prior therapy with a similar mechanism of action to KQB198
  2. * 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
  3. * History of interstitial lung disease
  4. * Cardiac abnormalities

Contacts and Locations

Study Contact

Kumquat Clinical Development
CONTACT
(858) 214-2700
kumquatstudies@kumquatbio.com

Study Locations (Sites)

Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101
United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Kumquat Biosciences Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2027-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor, Adult