145 Participants NeededMy employer runs this trial

KST-6051 for Cancer

Recruiting at 8 trial locations
KT
Overseen ByKestrel Therapeutics, Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Kestrel Therapeutics, Inc.
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 aims to test a new oral drug, KST-6051, for individuals with advanced or metastatic solid tumors, such as certain lung or pancreatic cancers, that have specific KRAS mutations. The primary goal is to assess the drug's safety and tolerability. Candidates may qualify if they have a tumor with a KRAS mutation and have not responded well to standard treatments. The study will explore different doses to determine the optimal one. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have been treated with RAS or KRAS inhibitors before.

Is there any evidence suggesting that KST-6051 is likely to be safe for humans?

Research has shown that KST-6051 is a promising new treatment tested for safety when taken orally. It targets specific cancer changes called KRAS mutations, common in some cancer types. This treatment is in early testing stages, with its safety in humans just beginning to be assessed.

Currently, detailed safety information is limited. Early tests, like the one under consideration, typically focus on understanding how well people tolerate a new drug. Researchers closely monitor for any side effects or adverse reactions. As an early-phase trial, the primary goal is to ensure the treatment does not cause significant harm to participants.

In summary, the safety of KST-6051 in humans remains under study. Trial participants will be closely monitored to ensure their safety as researchers gather more information on how the treatment affects human health.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about KST-6051 because it offers a new approach to treating cancer by potentially targeting cancer cells in a novel way. Unlike many standard chemotherapy treatments that indiscriminately attack both healthy and cancerous cells, KST-6051 is believed to work by homing in on specific pathways unique to cancer cells, which may reduce side effects and improve effectiveness. Additionally, this treatment involves a dose-escalation strategy, allowing for precise adjustment to find the most effective and safest dose, which is an innovative step towards personalized cancer care.

What evidence suggests that KST-6051 might be an effective treatment for cancer?

Research has shown that KST-6051 is a promising treatment for cancers caused by KRAS mutations. It blocks KRAS in both its active and inactive states, helping to stop cancer growth. Early studies demonstrated that this drug can be effective at doses patients tolerate well. KST-6051 holds strong potential because it targets KRAS mutations, common in many difficult-to-treat cancers. This treatment aims to address significant unmet needs for these patients.26789

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors (like lung, pancreatic, colon, or bile duct cancer) that have a KRAS mutation. Participants must be in good general health, able to swallow pills, and have already tried standard treatments without success.

Inclusion Criteria

I have advanced or metastatic cancer that cannot be removed by surgery.
My cancer has a confirmed KRAS mutation.
Willing and able to give written informed consent
See 5 more

Exclusion Criteria

Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial
I have been treated with RAS or KRAS inhibitors.
I have tumors or cancer that has spread to my brain or spinal cord.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Sequential cohorts with increasing doses of KST-6051 are evaluated to determine recommended dose(s) for expansion

Ongoing as long as participants benefit and tolerate the treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • KST-6051

Trial Overview

The study is testing different doses of an oral drug called KST-6051 to see if it’s safe and tolerable in people with KRAS-mutated cancers. It’s an early-phase (Phase 1), dose-escalation trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: KST-6051 Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kestrel Therapeutics, Inc.

Lead Sponsor

Citations

Kestrel Therapeutics Announces IND Clearance by U.S. ...

KST-6051 is a potent and selective inhibitor of KRAS with activity against KRAS in both its active (GTP-bound) and inactive (GDP-bound) states.

Kestrel Therapeutics Announces First Patient Dosed in the ...

We believe KST-6051 has the potential to address significant unmet medical needs in patients with KRAS-driven cancers, and look forward to ...

Pan-KRAS gets even more crowded | ApexOnco

Kestrel is claiming potential best-in-class efficacy with its project, KST-6051, but it's behind other players in this space, which include the ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41544598/

KRAS-mutant advanced NSCLC: efficacy and clinical ...

Results: Across KRAS and G12C NMAs, immunotherapy-based regimens generally outperformed chemotherapy-based regimens. PD-(L)1 inhibitors monotherapy ranked ...

Kestrel has entered into a warrant agreement with AbbVie ...

KST-6051 is a potent and selective inhibitor of KRAS with activity against KRAS in both its active (GTP-bound) and inactive (GDP-bound) states, ...

FDA-Approves-KST-6051.pdf

The trial, designed to evaluate safety, tolerability and preliminary anti-tumor activity, will enroll patients with advanced or metastatic KRAS-.

AbbVie throws its hat into the RAS ring

The FALCON study will assess the safety and early antitumour activity of KST-6051 in patients whose tumours have progressed following standard ...

Kestrel Therapeutics Announces IND Clearance by U.S. ...

KST-6051 is a potent and selective inhibitor of KRAS with activity against KRAS in both its active (GTP-bound) and inactive (GDP-bound) states.

Promising New KRAS Inhibitor Trial Doses Its First Patient

KST-6051 is designed to bind KRAS in both GTP- and GDP-bound states ... Jon, a computer data scientist, focuses on the latest clinical trial ...