EUCTR2020-005802-24-ES
Active, not recruiting
Phase 1
A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects with Advanced Esophageal or Esophagogastric Junction Cancers - SURPASS-2 study
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Adaptimmune LLC
- Enrollment
- 45
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. Subject (or legally authorized representative) has voluntarily agreed to participate by giving written Informed Consent/Assent (as applicable) in accordance with International Council for Harmonization (ICH) GCP guidelines and applicable local regulations.
- •2\. Subject (or legally authorized representative) has agreed to abide by all protocol\-required procedures including study\-related assessments and management by the treating institution for the duration of the study, including the LTFU.
- •3\. Age \= 18 years to \= 75 years at the time the Pre\-screening Informed Consent.
- •4\. Histologically or cytogenetically confirmed diagnosis of advanced (metastatic or inoperable) esophageal or EGJ cancers.
- •5\. Subject has received prior treatment for advanced or metastatic disease before treatment with ADP\-A2M4CD8 as the next therapy.
- •a. Esophageal or EGJ cancers
- •Prior therapy requirements in the unresectable locally advanced or metastatic setting:
- •\- Subjects should have received a platinum and/or fluoropyrimidine\-based regimen (such as FOLFOX).
- •\- Subjects may have been offered taxane\-containing regimen, ramucirumab, and/or irinotecan\-containing regimen, if available; unless discussed and agreed upon with the sponsor.
- •\- Subjects whose tumors are known to be HER2/neu positive should have received or refused trastuzumab, if available.
Exclusion Criteria
- •1\. Positive for HLA\-A\*02:05 in either allele via Adaptimmune\-designated central laboratory testing. HLA\-A\*02 alleles having the same protein sequence as HLA\-A\*02:05 in the peptide binding domains (P groups) will also be excluded. Other alleles may be exclusionary after adjudication with the Sponsor.
- •2\. Received or plans to receive the therapy/treatment listed in the protocol prior to leukapheresis or lymphodepleting chemotherapy.
- •3\. Toxicity from previous anti\-cancer therapy must have recovered to \= Grade 1 prior to enrollment (except for non\-clinically significant toxicities, e.g., alopecia and vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
- •4\. History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide, or other agents used in the study.
- •5\. History of autoimmune or immune\-mediated disease. Subjects with hypothyroidism, diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy are eligible. Subjects with disorders such as asthma, psoriasis, or atopic dermatitis that are well controlled without requiring systemic immunosuppression are also eligible.
- •6\. Leptomeningeal disease, carcinomatous meningitis, or symptomatic CNS metastases. Subjects with a prior history of symptomatic CNS metastases must have received treatment (i.e., stereotactic radiosurgery and whole brain radiation or surgery) and be neurologically stable for at least 1 month, not requiring anti\-seizure medications and off of steroids for at
- •least 14 days prior to leukapheresis and lymphodepletion. Anti\-seizure prophylaxis is permitted. Subjects who have asymptomatic CNS metastases without associated edema, shift, requirement for steroids, or anti\-seizure medications for the treatment of seizures are eligible.
- •7\. Any other prior malignancy that is not in complete remission. Resectable squamous or basal cell carcinoma of the skin is acceptable. Prior malignancies that have been surgically resected and show no evidence of disease are acceptable.
- •8\. Uncontrolled intercurrent illness including, but not limited to:
- •\- Ongoing or active infection
Investigators
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