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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT03725605
Eligibility Criteria:
Inclusion Criteria:
* Advanced/metastatic soft tissue sarcoma that is stable or has progressed on or after minimum 1 line of systemic treatment of advanced/metastatic disease
* At least 1 index lesion accessible for injection
* At least 1 measurable non-injected lesion that can be used for response willing to undergo repeat biopsy and tumour resection procedures
* Age between 18 and 75 years
* ECOG performance status of 0-1
* Meet following blood laboratory criteria: ANC \>/= 1.5, Platelet count \>/=75, - Haemoglobin \>/=6mmol/L, AST and ALT \</=2.5 x ULN, Creatinine \</=1.5 ULN
* Willing to comply with the protocol requirements and follow-up
* Signed informed consent
Exclusion Criteria:
* A history of clinically significant active systemic autoimmune disease requiring anti inflammatory or immunosuppressive therapy within the last 3 months
* Other active malignancy within the previous 5 years except for carcinoma in situ of cervix, ductal r lobular carcinoma in situ of the breast
* Received an investigational drug within 4 weeks prior to receipt of study drug
* Received external radiotherapy or cytotoxic chemotherapy within 4 weeks prior to LTX-315 administration or have not recovered from AEs (to\</= grade 1) Palliative radiotherapy to non target and lesions planned for LTX-315 injection within 4 weeks of LTX-315 administration is allowed
* Currently taking any agent with a known effect on the immune system. Stable doses of corticosteroids(up to 10mg prednisolone or equivalent) are permitted for at least 2 weeks prior to LTX-315 administration
* Any serious illness or medical condition such, but not limited to: uncontrolled infection or infection requiring antibiotics, uncontrolled cardiac failure, uncontrolled systemic and gastrointestinal inflammatory conditions, bone marrow dysplasia
* Known to test positive for HIV/AIDs, syphilis, human T-cell leukemia-lymphoma virus, active Epstein Barr, hepatitis B or C.
* history of cerebro- or cardio-vascular disorders and would be of particular risk of sequelae following a hypotensive episode
* If of child bearing potential, not willing to use effective form of contraception
* Breastfeeding and/or have a positive pregnancy test
* Donate sperm from start to 3 months after study treatment
* Expected to need any other anticancer treatment or immunotherapy during the treatment period
* Clinically active or unstable central nervous system metastases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03725605
Study Brief:
Protocol Section:
NCT03725605