78 Participants Needed

KQB548 for Solid Tumor Cancers

Recruiting at 5 trial locations
KC
Overseen ByKumquat Clinical Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KQB548 for individuals with advanced solid tumors, specifically those with a KRAS G12D mutation. The trial aims to determine if KQB548 can shrink tumors and how the body processes it. It will also establish the safe dosage of the drug. Potential participants have certain types of cancer, such as pancreatic, colorectal, or lung cancer, that have progressed after standard treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications, specifically strong or moderate CYP3A inhibitors or inducers, and proton-pump inhibitors. If you are on these medications, you may need to stop them to participate in the trial.

Is there any evidence suggesting that KQB548 is likely to be safe for humans?

Research has shown that KQB548 is being tested for safety and effectiveness in treating advanced solid tumors with the KRAS G12D mutation. As this trial is in its early stages, the primary goal is to determine a safe dose for humans and understand how the body processes the treatment.

Early studies focus mainly on safety. Although detailed safety information for KQB548 is not yet available, researchers closely monitor any side effects and how well patients tolerate the treatment. Results from this phase will determine if the treatment is safe enough for larger studies.

Even without specific safety data from earlier trials, this stage is crucial for ensuring safety before proceeding to larger studies.12345

Why do researchers think this study treatment might be promising?

KQB548 is unique because it targets solid tumor cancers in a way that traditional treatments like chemotherapy and radiation don't. Unlike these standard options that attack both cancerous and healthy cells, KQB548 is designed to specifically target tumor cells, potentially reducing side effects. Researchers are excited about KQB548's novel mechanism of action, as it may offer a more precise and effective approach to treating solid tumors, potentially leading to better patient outcomes.

What evidence suggests that KQB548 might be an effective treatment for solid tumor cancers?

Research shows that KQB548 is being developed to treat cancers with a specific genetic change known as KRAS G12D. This mutation is common in many solid tumors, making them difficult to treat. KQB548 is designed to directly target this change, potentially stopping cancer cell growth. Early studies suggest that treatments focusing on specific genetic changes can shrink tumors and slow disease progression. However, detailed information about its effectiveness in humans remains limited. The current trial primarily evaluates the safety and pharmacokinetics of KQB548 in the Monotherapy Dose Escalation arm.13467

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors that have a specific genetic change called KRAS G12D mutation. The exact eligibility criteria are not provided, but typically participants must be adults with measurable disease who can take oral medication and have acceptable organ function.

Inclusion Criteria

Measurable disease according to RECIST v1.1
My cancer is advanced and has a specific KRAS mutation.
My condition worsened or I couldn't tolerate at least one standard treatment.
See 1 more

Exclusion Criteria

I need to take medication to reduce stomach acid.
I have been treated with a KRAS G12D or pan-RAS inhibitor before.
I do not have any major gut issues that affect medication absorption.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KQB548 to evaluate safety, tolerability, and efficacy in treating advanced solid malignancies with a KRAS G12D mutation

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • KQB548
Trial Overview The study is testing KQB548, a new drug for treating advanced solid malignancies with the KRAS G12D mutation. It aims to determine the safe dosage, measure tumor response to treatment, and understand how the body processes the drug.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Monotherapy Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kumquat Biosciences Inc.

Lead Sponsor

Trials
3
Recruited
350+

Citations

A Study to Investigate the Safety and Efficacy of KQB548 ...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 ...
KQB548 for Solid Tumor CancersThe goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation.
A Study to Investigate the Safety and Efficacy of KQB548 ...The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation.
A Study to Investigate the Safety and Efficacy of KQB548The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation.
Bayer and Kumquat Biosciences initiate Phase I study with ...The first-in-human, dose-escalation study (NCT07207707) will evaluate the safety and preliminary efficacy of KQB548 (BAY 3771249) as a ...
A Study to Investigate the Safety and Efficacy of KQB548 in ...The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation.
A Phase 1a, Open-label, Multicenter, Study Evaluating the ...The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security