EPITOME-1015-I: a Study to Investigate the Safety and Tolerability of MDG1015 in Patients with Ep… (NCT06748872) | Clinical Trial Compass
Not Yet RecruitingPhase 1
EPITOME-1015-I: a Study to Investigate the Safety and Tolerability of MDG1015 in Patients with Epithelial Ovarian Cancer, Gastroesophageal Adenocarcinoma, Round Cell Liposarcoma And/or Synovial Sarcoma
United States55 participantsStarted 2025-07-01
Plain-language summary
MDG1015 is a third generation TCR-T therapy product targeting NY-ESO-1/LAGE-1a armored and enhanced by the PD1-41BB costimulatory switch protein (CSP). The study purpose is to establish the safety, tolerability and preliminary efficacy of MDG1015 in patients with epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma and/or synovial sarcoma that expresses NY-ESO-1 and/or LAGE-1a.
The main questions this clinical trial aims to answer are:
Can this TCR-T therapy MDG1015 be given to patients safely? What is the optimal dose of the TCR-T therapy MDG1015? If and what side effects do participants experience after receiving the TCR-T therapy MDG1015? Do participants experience a potential disease response after receiving the TCR-T therapy MDG1015?
Participants will:
Receive (in most cases) 1 single infusion of MDG1015 at a pre-defined dose level and will be followed up regularly up to 1 year. After one year, participants will enter the long term follow-up part up to 15 years after being treated. Any side effects and/or potential disease response will be documented during this period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult, ≥ 18 years of age and weigh ≥ 40 kg for Dose levels 1-3 and ≥ 50 kg for Dose level 4
✓. Subject must have a confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer Gastric or esophageal (junction) adenocarcinoma Myxoid (round cell) liposarcoma Synovial sarcoma
✓. Subject's must have tested positive for HLA-A\*02:01 genotype by a Sponsor designated central laboratory
✓. Subject's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a mRNA expression by a Sponsor designated central laboratory Both ≤1 year old archival tissue or fresh biopsy are allowed
✓. Subjects diagnosed with an eligible indication must have exhausted treatment options with proven survival benefit
✓. Subjects must have
✓. measurable disease
✓. Life expectancy ≥ 3 months per Investigator's opinion
Exclusion criteria
✕
What they're measuring
1
DE Segment: Adverse Events and Dose Limiting Toxicities (Safety and Tolerability)
. Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
✕. HLA-A\*02:02 or HLA-A\*02:03 genotype
✕. Pregnant or lactating women
✕. Viral serology:
✕. Known infection with HIV-1/2, CMV (CMV required only for U.S. sites) or HTLV-1/2,
✕. Active infection with HBV or HCV
✕. Positive test for Mycoplasma or Treponema Pallidum
✕. Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC (patients receiving prophylactic antibiotics are eligible)