Overview
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.
Eligibility
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