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

Conditions

Advanced Cancer, Metastatic Cancer, Solid Tumor

Brief summary

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.

Devalingam Mahalingam, Angela Alistar, Andrew Hendifar, Jin‐Ho Choi, Kiyean Nam et al. (6 authors)

Cancer Research2025-04-25

10.1158/1538-7445.am2025-ct072

645 A phase 1B/2, open-label study of Q702 in combination with intravenous pembrolizumab in patients with selected advanced solid tumors

Seung-Tae Kim, Hong Jae Chon, Do‐Youn Oh, Jaspreet Singh Grewal, Sun Young Rha et al. (19 authors)

Regular and Young Investigator Award Abstracts2023-10-31

10.1136/jitc-2023-sitc2023.0645

651 A phase 1, multicenter, open-label, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of Q702 with a cohort expansion at the RP2D in patients with advanced solid tumors

Devalingam Mahalingam, Angela Alistar, Alain C. Mita, Jeongjun Kim, Hyunji Ahn et al. (16 authors)

Regular and Young Investigator Award Abstracts2023-10-31

10.1136/jitc-2023-sitc2023.0651

Abstract 2255: Patient pharmacodynamic biomarker and pk evaluation results from an ongoing phase I dose-escalation study of q702, an axl, mer and csf1r kinase inhibitor in patients with advanced solid tumors

Bae Jung Choi, Devalingam Devalingam, Angela Alistar, Anthony B. El-Khoueiry, Alain C. Mita et al. (15 authors)

Cancer Research2023-04-043 citations

10.1158/1538-7445.am2023-2255

A phase 1, multicenter, open-label, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of Q702 with a cohort expansion at the RP2D in patients with advanced solid tumors.

Angela Alistar, Anthony B. El-Khoueiry, Devalingam Mahalingam, Monica Mita, Hwankyu Kang et al. (14 authors)

Journal of Clinical Oncology2021-05-201 citations

10.1200/jco.2021.39.15_suppl.tps2673

Interventions

DRUGQ702

The study drug Q702 will be administered once daily by mouth on Days 1 through 7 and Days 15 through 21 of every treatment cycle.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and the safety profile of Q702	28 days of cycle 1

Secondary

Measure	Time frame
Change in the area under curve (AUC) of Q702	Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Change in the maximum plasma concentration (Cmax) of Q702	Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Change in the time of maximum plasma concentration (Tmax) of Q702	Cycle 1, Days 1,2,8,15,21,22; Cycle 2, Days 1,8,15,22
Tumor response using RECIST version 1.1 throughout study	Baseline up to approximately 2 years

Countries

United States

Outcome results

None listed