Trial Details

A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors

NCT05438420

RECRUITING

DESCRIPTION

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.

CONDITIONS

ELIGIBILITY CRITERIA

• 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