A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKumquat Biosciences Inc.

About this trial

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?

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • KQB548

Treatment groups

78 Participants
are divided into 1 treatment group

Sponsors and collaborators