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:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT03490669
Eligibility Criteria:
Inclusion Criteria (All patients):
* Confirmed Advanced Unresectable Solid Tumor
* Measurable disease by RECIST 1.1 by CT or MRI
* Documented disease progression on or following last line of therapy
* Archival tumor sample for submission
* ECOG performance status 0 or 1
* Resolution of all acute, reversible toxic effects of prior therapy or surgical procedures to at least grade 1 (except alopecia and peripheral neuropathy to at least grade 2)
* Adequate organ function
* A limited number of patients enrolled in Dose Escalation may be required to agree to pre- and on-treatment tumor biopsies
Inclusion Criteria (Dose Expansion patients only)
* LIF- High NSCLC, Ovarian Cancer, or Pancreatic Cancer for the tumor-specific cohorts or Advanced Solid Tumor for the basket cohort as assessed by tumor tissue evaluation by IHC
* All patients enrolled in Dose Expansion must agree to undergo pre- and on-treatment tumor biopsies
Exclusion Criteria (All Patients):
* Systemic anti-cancer therapy within 4 weeks or 5 half-lives prior to study entry
* Previous or concurrent malignancy that could affect compliance with protocol or interpretation of results
* Clinically significant, unstable cardiovascular or pulmonary disease as specified in detail in the study protocol
* History of acquired or congenital immunodeficiency syndrome or receiving immunosuppressive therapy
* Uncontrolled infections or serologically positive HIV or hepatitis B or C infection
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or interfere with interpretation of study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03490669
Study Brief:
Protocol Section:
NCT03490669