46 Participants NeededMy employer runs this trial

KQB198 + Imatinib for GIST

Recruiting at 16 trial locations
KC
Overseen ByKumquat Clinical Development
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kumquat Biosciences Inc.
Must be taking: Imatinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug combination to determine its safety and effectiveness in treating GIST, a tumor in the digestive tract. The trial combines an experimental drug, KQB198, with imatinib, a medicine already approved for treating various cancers, including GIST. It targets individuals whose GIST cannot be surgically removed or has metastasized, and who have specific genetic mutations in their tumors. Participants should be in the first stage of treatment for advanced GIST and must not have taken imatinib for at least a year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of potentially effective therapies.

Do I have 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, since the study involves taking imatinib, you may need to discuss with the trial team if any of your current medications interact with it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that imatinib is safe and the FDA has approved it for treating various cancers, including gastrointestinal stromal tumors (GIST). This indicates that patients generally tolerate imatinib well. However, KQB198 remains an experimental drug under investigation. Researchers are assessing its efficacy and safety when combined with imatinib.

Although limited safety information exists for KQB198, its progression to a Phase 2 trial indicates it passed initial safety tests in earlier studies. These studies focused on determining a safe dose and identifying serious side effects. Researchers are now evaluating how well patients tolerate the combination of KQB198 and imatinib.

Prospective trial participants should discuss potential risks and side effects with the study team, who can provide detailed and personalized information.12345

Why are researchers excited about this trial's treatments for GIST?

Researchers are excited about KQB198 in combination with Imatinib for treating gastrointestinal stromal tumors (GIST) because it offers a novel approach beyond the traditional treatment. Imatinib has long been the standard of care, working by inhibiting specific tyrosine kinases. However, KQB198 introduces a new active ingredient that might enhance Imatinib's effectiveness by targeting additional pathways involved in tumor growth. This combination could potentially improve patient outcomes by addressing resistance mechanisms that limit the efficacy of Imatinib alone.

What evidence suggests that this trial's treatments could be effective for GIST?

Studies have shown that imatinib effectively treats gastrointestinal stromal tumors (GIST). About half of the patients with advanced GIST respond to imatinib treatment for approximately two years, with some benefiting even longer. However, over time, some tumors stop responding, reducing the drug's effectiveness. This trial tests the experimental drug KQB198 in combination with imatinib to see if it can enhance treatment results. Although limited information exists on KQB198 alone, combining it with imatinib might improve treatment by attacking the tumors in a new way.12346

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic gastrointestinal stromal tumors (GIST) who have specific gene mutations (KIT, except exon 9; PDGFRA, except D842V), have not had prior treatment for advanced disease, and whose major organs are working well.

Inclusion Criteria

My diagnosis of GIST was confirmed through a tissue sample.
My tests show a KIT mutation (not exon 9) or PDGFRA mutation (not D842V).
My organs are working well and I can do daily activities.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KQB198 in combination with imatinib to evaluate efficacy, safety, and tolerability

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Imatinib
  • KQB198

Trial Overview

The study is testing a new drug called KQB198 combined with imatinib (an approved cancer medicine) to see if this combination is safe and effective as the first treatment for people with advanced GIST.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: KQB198 in Combination with ImatinibExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kumquat Biosciences Inc.

Lead Sponsor

Trials
3
Recruited
350+

Citations

Survival Outcomes Associated With 3 Years vs 1 ... - PMC - NIH

Three years of treatment with adjuvant imatinib was associated with improved OS compared with 1 year of imatinib in patients with high-risk GIST.

trial detail - GIST clinical trials

This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and ...

Efficacy evaluation of imatinib treatment in patients with ... - PMC

These results suggest that 400 mg imatinib should be administered twice a day to patients with tumors bearing KIT exon 9 mutations. Other patients could safely ...

KQB198 in Combination With Imatinib in Participants ...

Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria in Gastrointestinal Stromal Tumors (GIST).

KQB198 in Combination With Imatinib in Participants With ...

This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe ...

Clinical Trial on Gastrointenstinal Stromal Tumor (GIST) - Clinical ...

Gastrointestinal stromal tumour (GIST) is a rare malignancy for which long-term treatment with tyrosine kinase inhibitors (TKIs), particularly imatinib, has ...