RecruitingRefractory CancerRecurrent CancerSolid Tumor, Adult

ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).

Sponsor: Immatics US, Inc.

You may qualify if…

✓ Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.
✓ Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓ HLA-A\*02:01 positive
✓ For patients with ovarian/fallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
✓ For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial carcinoma.
✓ Measurable disease according to RECIST 1.1
✓ Adequate selected organ function per protocol
✓ Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR. Retrospective testing will be required for patients that qualify.

You may not qualify if…

✕ History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
✕ Pregnant or breastfeeding
✕ Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
✕ History of cardiac conditions as per protocol
✕ Prior stem cell transplantation or solid organ transplantation
✕ Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
✕ History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
✕ Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.