An open-label phase II single-centre study investigating the safety and efficacy of LTX-315 and adoptive T-cell therapy in patients with advanced/metastatic soft tissue sarcoma
- Conditions
- Soft tissue sarcomaMedDRA version: 20.0Level: HLGTClassification code 10072990Term: Soft tissue neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-002877-20-DK
- Lead Sponsor
- ytix Biopharma AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6
1. (Histologically) Confirmed any patients with advanced or metastatic soft tissue sarcoma with stable disease or has progressed after a minimum of 1 systemic treatment of advanced/metastatic disease. Patient will have received at least 1 approved standard of care treatment for advanced/metastatic disease or be deemed unsuitable for such treatment by their treating physician
2. At least 1 index tumour lesion accessible for injection with a longest diameter (LD) of = 1cm which is planned for LTX-315 injection
3. At least 1 measurable (target) non-injected tumour lesion that can be used to assess response by Computed Tomography (CT-scan) (as per RECIST)
4. A life expectancy of at least 3 months
5. Willing to undergo repeat tumour biopsy and/or tumour resection procedures
6. Between 18 and 75 years of age
7. An Eastern Cooperative Oncology Group (ECOG) performance status: 0 – 1
8. Meet the following blood laboratory requirements:
a. Absolute neutrophil count (ANC) = 1.5 x 109/L
b. Platelet count = 75 x 109/L
c. Haemoglobin = 6.0 mmol/L after blood transfusion if needed
d. Prothrombin time / International Normalised Ratio (PT/INR) within the
institution’s normal range
e. Aspartate Transferase (AST) and Alanine Transferase (ALT) = 2.5 x upper normal level
f. Creatinine = 1.5 x upper normal level
9. Willing and able to comply with the protocol and agree to return to the hospital for follow-up visits and examinations up to 15 months after EoT
10. Fully informed about the study and have signed the informed consent form
11. Re-screening is allowed once on a case by case basis as judged by the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
1. A history of clinical significant active systemic autoimmune disease requiring antiinflammatory or immunosuppressive therapy within the last 3 months. Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy and disease has been stable for = 1 year
2. Any other malignancy active within the previous 5 years except for carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast
3. Received an investigational drug within 4 weeks prior to any study drug administration, or are scheduled to receive 1 during the study participation
4. Received external radiotherapy or cytotoxic chemotherapy within 4 weeks prior to LTX-315 administration, or have not recovered from AEs (to = CTCAE grade 1) due to agents administered more than 4 weeks earlier. Palliative radiotherapy to nontarget and lesions planned for LTX-315 injection within 4 weeks of LTX-315 administration is allowed
5. Currently taking any agent with a known effect on the immune system. Patients are allowed to be on a stable dose of corticosteroids (up to 10 mg daily prednisolone or equivalent) for at least 2 weeks prior to LTX-315 administration
6. Any other serious illness or medical condition such as, but not limited to:
a. Uncontrolled infection or infection requiring antibiotics
b. Uncontrolled cardiac failure: Classification III or IV (New York Heart
Association)
c. Uncontrolled systemic and gastrointestinal inflammatory conditions
d. Bone marrow dysplasia
7. A known history of positive tests for HIV/AIDS, syphilis, human T-cell leukemialymphoma virus (HTLV), active Epstein-Barr, hepatitis B or C (based on serology)
8. A history of cerebrovascular or cardiac disorders and would be at particular risk of sequelae following a short hypotensive episode
9. If of child-bearing potential, not willing to use an effective form of contraception such as hormonal birth control, intrauterine device or double barrier method from screening visit and until 3 months after last study treatment (any of the agents)
10. Breastfeeding and/or have a positive pregnancy test during screening
11. Donate sperm from LTX-315 dosing until 3 months after last study treatment (any of the agents)
12. Patients with pregnant or partner of child-bearing potential not willing to use contraception from LTX-315 administration until 3 months after last study treatment (any of the agents)
13. Expected to need any other anticancer therapy or immunotherapy to be initiated during the treatment period
14. Clinically active or unstable metastases in the central nerveous system as assessed by the treating physician
15. Any known hypersensitivity to any of the excipients in the non-IMPs including the required allergic prophylactic medications (H1 and H2 antagonists, Leukotriene antagonists)
16. Any known or suspected hypersensitivity to any of the IMPs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method