Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling

Neoplasms Clinical Trial

Official title:

Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760952
• Other study ID #: IMA-SCREENING
• Status: Completed
• Start date: February 26, 2019
• Est. completion date: November 15, 2022

Study information

• Verified date: February 2024
• Source: Immatics US, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The purpose of this screening study is to identify human leukocyte antigen (HLA) molecular subtype positive and tumor antigen target(s) positive patients. No treatment intervention will occur as part of this screening study. After diagnosis of advanced and/or solid metastatic cancers, patients will be tested for HLA molecular subtype positivity. Patients that are HLA molecular subtype positive are then assessed to determine if their tumor antigen target(s) is positive (biopsy screening). Fresh tumor tissue obtained by a biopsy for this screening study will be required. If the patient is undergoing a surgical procedure directed towards tumor or palliative treatment (e.g., a resection, debulking surgery, etc.) and has consented to the study, then fresh tissue may be collected during the procedure to avoid the patient being subjected to another biopsy. Tumor antigen targets in fresh tumor samples will be determined by an in vitro diagnostic (IVD) assay. Therefore, any remaining tumor specimens may be used for exploratory biomarker analyses and validation studies for regulatory approval. Immatics is conducting clinical studies which target patients with advanced and/or metastatic solid cancers. Patients who are HLA subtype phenotype positive and whose tumors express one or more of the tumor antigen targets of interest may be eligible for ongoing clinical studies of adoptive cell therapy (ACT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed an Informed Consent Form (ICF)

2. Patients = 18 years of age

3. Patients with confirmed advanced and/or metastatic solid tumors.

4. 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.

5. Eastern Cooperative Oncology Group (ECOG) performance status = 0-1

6. Life expectancy > 6 months

7. There is no limitation for prior anti-cancer treatments

8. HLA molecular phenotype positive.

9. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)1.1

10. 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

11. Patient has adequate pulmonary function

12. Acceptable organ and marrow function

13. Acceptable coagulation status

14. Adequate hepatic function

15. Acceptable levels of serum creatinine

16. For liver cancer patients only, Child-Pugh score of < 6

Exclusion Criteria:

1. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years

2. Patients with primary central nervous system (CNS)/brain tumors

3. Patients whose tumors have very low expression of tumor antigen targets such as kidney chromophobe, thyroid carcinoma, and prostate adenocarcinoma

4. Patients who are pregnant or are breastfeeding

5. 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

6. Patients with prior stem cell transplantation or solid organ transplantation

7. Any condition contraindicating leukapheresis

8. 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

9. Patients with active diverticulitis, intra-abdominal abscess, or GI obstruction

10. Patients with active pneumonitis

11. 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.

12. History of hypersensitivity on fludarabine (FLU), cyclophosphamide (CY), or interleukin (IL)-2

13. History of current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator.

14. 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).

15. Patients with bleeding diathesis or coagulopathy

16. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with patient's safety

17. HIV infection, active hepatitis B or C infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and/or nucleic acid testing

Related Conditions & MeSH terms

• Adult Solid Tumor
• Neoplasms
• Recurrence
• Recurrent Cancer
• Refractory Cancer

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Oncology Consultants	Houston	Texas
United States	Columbia University Medical Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Immatics US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of antigen target expression in solid tumors		3 years
Other	Comparison of antigen target expression in fresh and FFPE tumor samples		3 years
Primary	Frequency of patients with protocol-specified HLA subtype		3 years
Primary	Frequency of patients with expression of analyzed tumor antigen targets		3 years