Experimental combo therapy targets hard-to-treat sarcoma
NCT ID NCT03725605
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a two-step treatment for people with advanced soft tissue sarcoma that had stopped responding to standard therapy. First, a drug called LTX-315 was injected into a tumor to attract immune cells. Then, that tumor was removed, and the immune cells were grown in a lab and infused back into the patient. The goal was to see if this approach was safe and could boost the body's immune attack on the cancer. Only 6 people took part, and the study focused on measuring immune cell changes and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
6 people
The number who actually took part.
- Started
-
Dec 2018
- Finished
-
Oct 2021
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Soft tissue sarcoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Herlev Hospital
Copenhagen, DK-2730, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Can a Marine-Derived drug slow advanced soft tissue sarcoma?
- Can a One-Two punch of immunotherapy and radiation tame sarcoma before surgery?
- Can a radioactive antibody light up hidden tumors?
- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Could a massive tissue bank unlock sarcoma's secrets?