Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling

NCT03760952 | Completed

• 1 other identifier: IMA-SCREENING
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 4

Brief Summary

This screening study will identify HLA molecular subtype positive and tumor antigen target(s) positive patients who may be eligible for enrollment into Immatics clinical studies. This screening study is intended for patients with advanced and/or metastatic solid cancers. No treatment intervention will occur as part of this screening study.

Conditions

Refractory Cancer; Recurrent Cancer; Adult Solid Tumor; Neoplasms

Keywords

T-cell therapy; Immunotherapy; Screening; Metastatic; Previously Treated

Outcome Measures

Primary Outcomes (2)

• Frequency of patients with protocol-specified HLA subtype

  3 years

• Frequency of patients with expression of analyzed tumor antigen targets

  3 years

Other Outcomes (2)

• Incidence of antigen target expression in solid tumors

  3 years

• Comparison of antigen target expression in fresh and FFPE tumor samples

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed advanced and/or metastatic solid tumors

You may qualify if:

• Signed an Informed Consent Form (ICF)
• Patients ≥ 18 years of age
• Patients with confirmed advanced and/or metastatic solid tumors.
• For liver cancer patients, the diagnosis must be confirmed
• Pathological diagnosis of liver cancer based on biopsy/resection is required
• For patients without pathological diagnosis, an imaging technique obtained by computed tomography (CT) scan or magnetic resonance imaging (MRI) is needed.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 0-1
• Life expectancy \> 6 months
• There is no limitation for prior anti-cancer treatments
• HLA molecular phenotype positive.
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)1.1
• At least one lesion considered accessible for biopsy unless fresh tumor tissue is being collected during a surgical procedure directed towards tumor treatment or palliative therapy or the patient has uterine cancer (including endometrial cancer or uterine carcinosarcoma) or melanoma
• Patient has adequate pulmonary function
• Acceptable organ and marrow function
• Acceptable coagulation status

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
• Patients with primary central nervous system (CNS)/brain tumors
• Patients whose tumors have very low expression of tumor antigen targets such as kidney chromophobe, thyroid carcinoma, and prostate adenocarcinoma
• Patients who are pregnant or are breastfeeding
• Patients with 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
• Patients with prior stem cell transplantation or solid organ transplantation
• Any condition contraindicating leukapheresis
• Patients with any of the following cardiac conditions: uncontrolled hypertension despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure, baseline left ventricular ejection fraction ≤ 50%, prior or current cardiomyopathy, atrial fibrillation with heart rate \> 100 bpm, unstable ischemic heart disease
• Patients with active diverticulitis, intra-abdominal abscess, or GI obstruction
• Patients with active pneumonitis
• Patients with active (uncontrolled/untreated) brain metastases NOTE: Patients with a history of brain metastases may be eligible, if an imaging scan with contrast enhancement not older than 4 weeks is able to exclude the existence of currently active brain metastasis.
• History of hypersensitivity on fludarabine (FLU), cyclophosphamide (CY), or interleukin (IL)-2
• History of current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator.
• Patients with Grade 3 or Grade 4 immune-related toxicities related to checkpoint inhibitors or patients requiring corticosteroid treatment (≥ 10 mg/day prednisone or equivalent dose).
• Patients with bleeding diathesis or coagulopathy

Sponsors & Collaborators

• Immatics US, Inc.: lead

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor Biopsy

MeSH Terms

Conditions

Neoplasms; Recurrence; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Cedrik Britten, M.D.

  Immatics US

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: February 26, 2019
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

US (4)