Selective Tyrosine Kinase Inhibitor for Solid Tumors

Not currently recruiting at 3 trial locations

Overseen By Qurient Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Qurient Co., Ltd.

Disqualifiers: Cardiac disease, Infections, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Q702, a selective tyrosine kinase inhibitor, to determine its safety and effectiveness in treating advanced solid tumors (cancerous growths without liquid areas). The main goal is to identify a safe dose and observe the drug's effects on the body and tumor. Participants will receive increasing doses of Q702. This trial may suit adults with solid tumors unresponsive to other treatments and who can perform daily activities without major limitations. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Q702 is likely to be safe for humans?

Research has shown that Q702, a new drug being tested for solid tumors, is generally safe. In earlier studies, patients tolerated Q702 well at doses up to 240 mg daily, with most not experiencing severe side effects.

Another study tested Q702 with pembrolizumab, another cancer treatment, and found this combination to be generally safe as well. These results suggest that patients usually tolerate Q702 well. It is important to note that this information comes from early studies, and ongoing research will provide more details about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Q702 is unique because it is a selective tyrosine kinase inhibitor specifically designed to target solid tumors. Most treatments for solid tumors, like chemotherapy and radiation, work by attacking rapidly dividing cells, which can affect both cancerous and healthy tissues. In contrast, Q702 targets specific enzymes called tyrosine kinases that are often overactive in cancer cells, potentially allowing for a more precise attack on the tumor while sparing healthy cells. Researchers are excited about Q702 because this targeted approach may lead to fewer side effects and improved effectiveness compared to traditional treatments.

What evidence suggests that Q702 might be an effective treatment for solid tumors?

Research shows that Q702, a new cancer drug, may help treat solid tumors. Studies have found that Q702 can slow tumor growth when used alone in various cancer types. In this trial, participants will receive escalating doses of Q702 to evaluate its safety and effectiveness. Although previous studies explored combining Q702 with pembrolizumab, this trial focuses solely on Q702. The drug targets specific proteins that aid cancer cell growth and spread. Overall, early findings suggest Q702 could be a strong option for fighting solid tumors. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors that have worsened after standard treatments, or when no effective standard treatment exists. Participants must be able to perform daily activities with ease or only slight limitations and should expect to live at least another 3 months.

Inclusion Criteria

My cancer has spread and worsened after standard treatment or lacks a beneficial standard treatment.

You are expected to live for at least 3 more months.

Measurable disease per RECIST v 1.1

Exclusion Criteria

Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470 msec (females) and >450 msec (males)

I do not have any ongoing serious infections needing treatment.

I have an active autoimmune or inflammatory disease that is not well-controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of Q702 to evaluate safety and anti-tumor activity

8-12 weeks

Cohort Expansion

Participants receive Q702 at the recommended phase 2 dose (RP2D) to further evaluate safety and efficacy

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Q702

Trial Overview The study is testing Q702, an oral medication aimed at certain cancer-related enzymes. It's in Phase 1 where researchers are figuring out the best dose by gradually increasing it among small groups of patients while monitoring safety and how well the drug works against tumors.

How Is the Trial Designed?

Group I: Dose escalation (Q702) Experimental Treatment 1 Intervention

Participants will receive escalating doses of Q702

Q702 is already approved in United States for the following indications:

Approved in United States as Q702 for:

• None approved; under investigation for various cancers including acute myeloid leukemia (AML), esophageal, gastric/GEJ, hepatocellular, and cervical cancers

Who Is Running the Clinical Trial?

Qurient Co., Ltd.

Lead Sponsor

Trials

10

Recruited

840+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2606

A phase 1b/2, open-label study of selective Axl, Mer and ... Preliminary data from QRNT-008 study showed that selective Axl/Mer/CSF1R inhibitor Q702 plus pembrolizumab has a manageable safety profile.

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT072/761597/Abstract-CT072-First-in-human-trial-of-Q702-in

Abstract CT072: First in human trial of Q702 in patients with ... Of 46 response evaluable patients, 12 achieved stable disease with 6 patients (1 in 14 mg, 4 in 120 mg and 1 in 240 mg) manifesting progression ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9563311/

A Novel Selective Axl/Mer/CSF1R Kinase Inhibitor as ... Our data indicate that therapy targeting both immune cells and cancer cells in the TME by Q702 can induce more effective clinical responses in patients with ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/348675

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor ... This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.TPS2673

A phase 1, multicenter, open-label, dose-escalation, safety, ... Q702, as a monotherapy, shows significant tumor growth inhibition in multiple syngeneic tumor models, and demonstrates synergistic effects with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04648254

Study Details | NCT04648254 | Oral Axl/Mer/CSF1R ... Oral Axl/​Mer/​CSF1R Selective Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumor ... safety and anti- tumor activity of Q702 administered orally.

7. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A742

651 A phase 1, multicenter, open-label, dose-escalation, ... Conclusions Q702 is a novel Axl/Mer/CSF1R inhibitor with a manageable monotherapy safety profile up to 240 mg daily and early signals of anti- ...