Phase
Condition
Abdominal Cancer
Neoplasms
Digestive System Neoplasms
Treatment
Ezabenlimab
Obrixtamig
BI 764532
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria
Age ≥18 years
Signed and dated, written informed consent form (main ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
Diagnosed with locally advanced, metastatic or relapsed cancer not amenable to curative treatment of the following histologies:
Small cell lung carcinoma (SCLC)
Large cells neuroendocrine lung carcinoma(LCNEC)
Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
Tumours must be positive for Delta-like 3 (DLL3) expression (on archived tissue) according to central pathology review in order to start obrixtamig.
Patients with tumors with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumor cells component is predominant and represent at least 50% of the overall tumor tissue.
Patient who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Subjects with brain metastases are eligible provided they meet the following criteria:
radiotherapy or surgery for brain metastases was completed at least 2 weeks or 4 weeks respectively, prior to the first administration of obrixtamig
patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant CNS disease.
- Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.These methods must be used during the study and for at least 3 months after the last dose of obrixtamig. A list of contraception methods meeting these criteria is provided in the patient information.
Further inclusion criteria apply.
Exclusion criteria
Previous treatment with T-cell-engager (TcE) or cell therapies targeting DLL3. Other DLL3 targeting agents (like RovaT) are allowed only if DLL3 positivity is documented after completion of treatment with DLL3 targeting agent in post-treatment biopsy.
Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:
effectively treated non-melanoma skin cancers
effectively treated carcinoma in situ of the cervix
effectively treated ductal carcinoma in situ
other effectively treated malignancy that is considered cured by local treatment
Major injuries and/or surgery or bone fracture within 28 days of first dose obrixtamig, or planned surgical procedures
Known leptomeningeal disease or spinal cord compression due to metastatic disease
Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed
Patients who have been febrile, have had leukocytosis, or any clinical signs of infection within 48 h prior to randomization/start of trial treatment are not eligible. Oral or intravenous antimicrobials for management of fungal, bacterial, viral, or other infection are prohibited within 7 days prior to randomization/start of trial treatment. The use of antimicrobials for routine infection prophylaxis is acceptable
Severe acute respiratory syndrome coronavirus 2 (SARS COV2) infection within 2 weeks prior to study entry (confirmed via Polymerase chain reaction (PCR) test or other applicable test as per local requirements) or suspected SARS-CoV-2 infection as per physician assessment, or close contact (within 1 week) with an individual with confirmed SARS-CoV-2 infection
Any of the following known laboratory evidence of hepatitis virus infection:
Positive results of hepatitis B surface (HBs) antigen
Presence of hepatitis B core (HBc) antibody together with hepatitis B virus (HBV)-Deoxyribonucleic Acid (DNA)
Presence of hepatitis C Ribonucleic acid (RNA) Further exclusion criteria apply.
Study Design
Connect with a study center
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
UNIV UZ Gent
Gent, 9000
BelgiumSite Not Available
HOP Louis Pradel
Bron, 69677
FranceSite Not Available
CTR François Baclesse
Caen, 14000
FranceSite Not Available
INS Claudius Regaud IUCT-Oncopole
Toulouse, 31059
FranceSite Not Available
Technische Universität Dresden
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanyActive - Recruiting
Universitätsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
JapanSite Not Available
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