RECRUITING

A Study to Investigate the Safety and Efficacy of KQB365 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 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.

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

Quick Facts

Study Start:2025-01-31
Study Completion:2030-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06720987

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 (monotherapy): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
  2. * 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.
  3. * Unresectable or metastatic disease
  4. * No available treatment with curative intent
  5. * Adequate organ function
  6. * Measurable disease per RECIST v1.1
  1. * Active primary central nervous system tumors
  2. * Cardiac abnormalities
  3. * Active interstitial lung disease

Contacts and Locations

Study Contact

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

Study Locations (Sites)

START Midwest
Grand Rapids, Michigan, 49546
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
NEXT Virginia, LLC
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 Date2025-01-31
Study Completion Date2030-06-30

Study Record Updates

Study Start Date2025-01-31
Study Completion Date2030-06-30

Terms related to this study

Keywords Provided by Researchers

  • cetuximab
  • KQB365

Additional Relevant MeSH Terms

  • KRAS G12C Mutation
  • KRAS G12S Mutation
  • Solid Tumor Malignancies
  • CRC (Colorectal Cancer)