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KQB548 for Advanced Solid Tumors with KRAS G12D Mutation

This study is testing a drug called KQB548 in people with advanced solid tumors, specifically pancreatic, colorectal, or non-small cell lung cancer, that have a specific genetic change called a KRAS G12D mutation. You would have already received at least one standard treatment that didn't work or you couldn't tolerate. The main goals are to find a safe dose of KQB548 and see if it can shrink tumors. The study also wants to understand how KQB548 works in the body. This study is currently unclear about its recruitment status and plans to enroll about 78 participants.

Study design
This is an interventional study with a planned enrollment of 78 participants. It is designed to evaluate the safety and effectiveness of oral KQB548.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured for up to 30 months.

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NCT07207707

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kumquat Biosciences Inc.
~78 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:KQB548

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety,Tolerability, MTD/MAD and/or RDE in the Study Population
Measured over Up to 30 months

Conditions

Solid Tumor Malignancies

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaSolid NeoplasmGTPase KRas

Where it's being run

13 sites across 9 states
Texas4
California2
Colorado1
Florida1
Michigan1
Ohio1
Utah1
Virginia1

Who to contact

Kumquat Clinical Development
[email protected]
858-214-2700
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Safety,Tolerability, MTD/MAD and/or RDE in the Study PopulationUp to 30 months

    Safety characterized by type, incidence and severity of treatment emergent adverse events (TEAEs), SAEs, and DLTs