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

Launched by MEDIGENE AG · Dec 23, 2024

Keywords

ClinConnect Summary

The EPITOME-1015-I clinical trial is investigating a new treatment called MDG1015 for patients with certain types of cancer, including epithelial ovarian cancer, gastroesophageal adenocarcinoma, and specific soft tissue sarcomas. This treatment uses advanced technology to help the immune system recognize and attack cancer cells. The main goals of the study are to find out if MDG1015 can be safely given to patients, determine the best dose, and see if it can help shrink tumors or improve patients' conditions.

To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of one of the eligible cancers. You should also have tested positive for specific markers related to the treatment and have already tried other therapies without success. If you decide to take part, you would receive a one-time infusion of the treatment and be monitored for up to a year, with follow-ups continuing for up to 15 years to assess any side effects or changes in your health. Please note that this trial is not yet recruiting participants, so it’s important to check back for updates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult, ≥ 18 years of age and weigh ≥ 40 kg for Dose levels 1-3 and ≥ 50 kg for Dose level 4
• • 2. 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
• • 3. Subject's must have tested positive for HLA-A\*02:01 genotype by a Sponsor designated central laboratory
• • 4. 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
• • 5. Subjects diagnosed with an eligible indication must have exhausted treatment options with proven survival benefit
• • 6. Subjects must have
• • 1. measurable disease
• • 2. Life expectancy ≥ 3 months per Investigator's opinion
• • 8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 9. Adequate vital organ function 10. Adequate bone marrow function 11. Adequate coagulation profile 12. Toxicities from prior/ongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0 or Subject's baseline excluding alopecia 14. Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1 15. Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)
• Exclusion Criteria:
• • 1. Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
• • 2. HLA-A\*02:02 or HLA-A\*02:03 genotype
• • 3. Pregnant or lactating women
• 4. Viral serology:
• • 1. Known infection with HIV-1/2, CMV (CMV required only for U.S. sites) or HTLV-1/2,
• • 2. Active infection with HBV or HCV
• • 3. Positive test for Mycoplasma or Treponema Pallidum
• • 5. 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)
• • 6. Inadequate venous access for or contraindications to leukapheresis
• • 7. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients, LDC agents, rasburicase, methylprednisolone or tocilizumab.
• • 8. Untreated CNS metastases or active CNS metastases (progressing or requiring corticosteroids for symptoms control) and leptomeningeal disease
• • 9. Unstable/active ulcer, varices, or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding
• 10. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. The following are exempt from the 1-year limit:
• • 1. non-melanoma skin cancer
• • 2. curatively treated localized prostate cancer
• • 3. carcinoma in situ (e.g. cervix, bladder, breast)
• • 11. NYHA Class ≥ II, heart failure, unstable angina, a history of recent (≤ 6 months) arrythmias, myocardial infarction or sustained (\> 30 seconds) ventricular tachyarrhythmias
• • 12. Subjects who are dependent on dialysis
• • 13. Subjects with a history of pulmonary embolism or deep vein thrombosis that cannot safely withhold anti-coagulant therapy from leukapheresis until 7 days after administration of MDG1015 as determined by the Investigator
• • 14. Active autoimmune disease requiring systemic therapy except for adequately controlled Type 1 diabetes mellitus, autoimmune hypothyroidism or Grave's disease
• • 15. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant
• Specific to GAC/GEJ Subjects:
• • 16. Positive history of esophageal or gastric resection that the Investigator considers is at increased risk of bleeding or perforation