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 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT04202705
Eligibility Criteria:
Main Inclusion Criteria:
* Patient with histologically-confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists, with the following restriction:
* Part 1: solid tumours of any origin
* Part 2: three patient cohorts
* Tumour 5T4 membrane staining according protocol
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
* Adequate organ function
* For Part 2: measurable disease
Main Exclusion Criteria:
* Having been treated with:
1. 5T4-targeting therapy at any time
2. Trastuzumab duocarmazine (SYD985) at any time
3. Other anticancer therapy within 4 weeks or as defined in the protocol
4. Hormone therapy within 1 week
* History or presence of keratitis, clinically significant renal disease, lung disease, or cardiovascular disease as specified in the protocol
* Symptomatic brain metastases, brain metastases requiring steroids or treatment for brain metastases within 8 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04202705
Study Brief:
Protocol Section:
NCT04202705