Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors

Qurient

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Gastric Cancer; Esophageal Cancer; Hepatocellular Cancer; Cervical Cancer

Treatments: Biological: Pembrolizumab; Drug: Q702

Study type: Interventional

Funder types: Industry

Identifiers

NCT05438420

MK-3475-D35 (KEYNOTE-D35) (Other Identifier)

QRNT-008

Details and patient eligibility

About

This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
• Subjects with histologically or cytologically confirmed advanced or metastatic esophageal, gastric/GEJ, hepatocellular and cervical cancers who have progressed on treatment with an anti-PD1 or anti PD-L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
• Have measurable disease per RECIST v 1.1. as assessed by local site investigator/radiology
• Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Life expectancy of at least 3 months

Exclusion criteria

• A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment or breast-feeding women
• Concomitant use of strong inhibitors and inducers of CYP1A2, 2J2, 2C19, 2D6, and 3A4/5 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
• Concomitant use of sensitive substrates of CYP2C9, 2C19, and 3A4 within the timeline duration of five half-lives prior to starting study drug and throughout the trial
• Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
• Has had an allogeneic tissue/solid organ transplant

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Dose escalation of Q702 in combination with fixed dose of pembrolizumab

Experimental group

Description:

Give one week on/one week off at selected dose level

Treatment:

Drug: Q702

Biological: Pembrolizumab

Dose expansion of Q702 in combination with fixed dose of pembrolizumab

Experimental group

Description:

Give intravenously once every three week at 200 mg

Treatment:

Drug: Q702

Biological: Pembrolizumab