Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05438420
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05438420
Study Brief:
Protocol Section:
NCT05438420