Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors (NCT03252938) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors
Germany83 participantsStarted 2017-08-15
Plain-language summary
This phase I trial aims to investigate a potential enhancement of IMP321 immune-activating effects by new routes of administration: direct injection of IMP321 into the tumor tissue; intra-peritoneal therapy; combination of chemotherapy and/or immunotherapy/targeted therapy with active immunotherapy
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically confirmed locally advanced (not manageable with curative intent) or metastatic solid tumor Specification for Stratum C: Only patients with NSCLC adenocarcinomas, (squamous or adenosquamous not permitted) who are scheduled to receive platin + pembrolizumab + pemetrexed standard treatment (only for Stratum C) Specification for Stratum E: Including only metastatic or irresectable locally advanced urothelial carcinomas - also refer to IC#14 below (only for Stratum E)
✓. Tumor is accessible for repeated injections and biopsies (only for Stratum A)
✓. Peritoneal carcinomatosis (only for Stratum B)
✓. Patient failed standard therapy or refused standard therapy or is intolerable towards standard therapy (Strata A, B, and D) or who receives Standard-of-Care first line treatment comprising platin + pembrolizumab + pemetrexed (only for Stratum C)
✓. Patient has not received more than 4 prior lines of therapy. Neoadjuvant/adjuvant treatment is not counted unless progression occurs \<6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one prior line (only for Stratum D).
Exclusion criteria
✕. Patients ≥ 18 years. Patients in reproductive age must be willing to use highly effective contraception during the study and 4 months after the end of the study (appropriate contraception is defined as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, bilateral tubal occlusion, sexual abstinence. If an oral contraception is used, a barrier method of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge) has to be applied additionally.). Female patients with childbearing potential need to have a negative pregnancy test within 7 days before study start.
What they're measuring
1
Feasibility rate
Timeframe: 10 weeks of treatment + 2 weeks of safety observation period
Trial details
NCT IDNCT03252938
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
✕. Adequate hematological, hepatic and renal function parameters:
✕. Adequate coagulation functions as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Patients receiving warfarin/ phenprocoumon must be switched to low molecular weight heparin (new oral anticoagulants (NOACs) are permitted) and have achieved stable coagulation profile.
✕0. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
✕1. Evidence of measurable disease as defined by RECIST v1.1 (only for Strata C, D and E) or assessable disease as defined by RECIST v1.1 (only for Stratum C)
✕2. Expected survival \> 3 months
✕3. Resolution of toxicity associated with prior or current therapy to grade \<2 (except for alopecia and transaminases in case of liver metastases)