Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumor

Qurient

Status and phase: Active, not recruiting; Phase 1

Conditions: Metastatic Cancer; Advanced Cancer; Solid Tumor

Treatments: Drug: Q702

Study type: Interventional

Funder types: Industry

Identifiers

NCT04648254

Q702-ONC-P1-US001

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically or cytologically confirmed advanced or metastatic solid tumors, that have progressed following standard of care therapy or for which there is no standard therapy which confers clinical benefit
• Measurable disease per RECIST v 1.1
• ECOG performance status 0 or 1
• Life expectancy of at least 3 months
• Age ≥ 18 years
• Signed, written IRB-approved informed consent form

Exclusion criteria

• New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
• Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470 msec (females) and >450 msec (males)
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Active, poorly controlled autoimmune or inflammatory diseases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Dose escalation (Q702)

Experimental group

Description:

Participants will receive escalating doses of Q702

Treatment:

Drug: Q702