Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
study ends around

Description

Summary

The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are:

  • What is the safe dose of KQB548?
  • Does KQB548 decrease the size of the tumor?
  • What happens to KQB548 in the body?

Official Title

A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation

Keywords

Solid Tumor Malignancies, KRAS, G12D, KQB548

Eligibility

You can join if…

Open to people ages 18 years and up

  • Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation
  • Progressed on, or intolerant to at least one prior line of systemic standard of care therapy
  • Measurable disease according to RECIST v1.1
  • Adequate organ function

You CAN'T join if...

  • Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor
  • History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications
  • Poorly controlled ascites and/or pleural effusion
  • Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer
  • Requires treatment with a proton-pump inhibitor

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92037 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kumquat Biosciences Inc.
ID
NCT07207707
Phase
Phase 1 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 78 study participants
Last Updated