Selective Tyrosine Kinase Inhibitor for Solid Tumors

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

78 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+