NADUNOLIMAB for Triple-negative breast cancer|Advanced triple-negative breast cancer

Inclusion criteria

• {"criterion_text":"- Signed informed consent form before conducting any specific procedure for the study."}
• {"criterion_text":"- Patients testing positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must meet ALL the following criteria: a. Have CD4+ T-cell (CD4+) counts ≥ 350 cells/µL; b. Have not had an opportunistic infection within the past 12 months. Patients on prophylactic antimicrobials can be included in the study; c. Should be on stable antiretroviral therapy for at least 4 weeks; d. Have an HIV viral load less than 400 copies/mL prior to enrolment."}
• {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures."}
• {"criterion_text":"- Negative serum pregnancy test within 7 days prior to enrolment for premenopausal women, and for women who have experienced menopause onset < 12 month prior to first dose of therapy. • For premenopausal women: agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study treatment. • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and to refrain from donating sperm during the same period, as defined below with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of carboplatin/gemcitabine to avoid exposing the embryo."}
• {"criterion_text":"- Female or male BC patients of ≥ 18 years of age."}
• {"criterion_text":"- Histologically confirmed TNBC that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic: a. Documented Hormone Receptor (HR) negative BC based on local laboratory determination on the most recent tumor biopsy; b. Documented Human Epidermal Growth Factor Receptor 2 (HER2) negative BC based on local laboratory determination on the most recent tumor biopsy; c. Patients are eligible for the study irrespectively of BRCA1/2 mutational status."}
• {"criterion_text":"- Patients should be eligible to receive gemcitabine and carboplatin as the following line of therapy. No more than 1 previous line of systemic therapy for the advanced disease is allowed."}
• {"criterion_text":"- Documented progressive disease (i.e. biopsy sample, pathology or imaging report) from the last treatment."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1."}
• {"criterion_text":"- Patients must have at least one measurable lesion that can be accurately assessed at baseline and is suitable for repeated assessment by CT scan, MRI, plan X-ray or physical examination."}
• {"criterion_text":"- Adequate organ and bone marrow function defined as follows: a. ANC ≥ 1.500/mm3 (1.5x109/L), without previous G-CSF within 2 weeks prior to the study treatment; b. Platelets ≥ 100.000/mm3 (100x109/L), without previous transfusion within 2 weeks prior to the study treatment; c. Hemoglobin ≥ 9 g/dL (90 g/L), without previous transfusion within 28 days before starting with the study treatment; d. Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min as calculated using the Cockcroft-Gault formula; e. Total serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if Gilbert´s disease); f. AST and/or ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if liver metastases present); g. Alkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if bone or liver metastases present)."}
• {"criterion_text":"- Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade ≤ 1"}

Exclusion criteria

• {"criterion_text":"- Patient has received extended field radiotherapy ≤ 4 weeks before the start of treatment (≤ 2 weeks for limited field radiation for palliation), and who has not recovered to ≤ Grade 1, according to NCI CTCAE v5.0, from related AEs of such therapy (except for alopecia)."}
• {"criterion_text":"- Pregnant or lactating or intending to become pregnant during or within 6 months after the last dose of study treatment."}
• {"criterion_text":"- Known hypersensitivity or allergy to any component of the nadunolimab, carboplatin or gemcitabine drug formulations, and known hypersensitivity to platinum-containing compounds."}
• {"criterion_text":"- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications."}
• {"criterion_text":"- Treatment with systemic anticancer treatments, investigational products, or major surgery within 4 weeks before the first dose of study drug or 5 half-lives, whichever is shorter."}
• {"criterion_text":"- Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina, known left ventricular ejection fraction (LVEF) < 50%."}
• {"criterion_text":"- Presence of an abnormal ECG that is clinically significant in the investigator’s opinion."}
• {"criterion_text":"- Patients with uncontrolled brain metastases."}
• {"criterion_text":"- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to enrolment."}
• {"criterion_text":"- Severe (Grade 3) infection requiring oral or IV antibiotics within 4 weeks prior to enrolment."}
• {"criterion_text":"- Positive hepatitis B surface antigen (HBsAg) test at screening. Total hepatitis B core antibody (HBcAb) test at screening must be negative."}
• {"criterion_text":"- Positive hepatitis C virus (HCV) antibody test at screening: if positive, HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test."}

Primary endpoints

• {"endpoint_text":"- Phase Ib: To determine the incidence rate of Dose Limiting Toxicity (DLT) within the first Cycle of nadunolimab in combination with GC.","definition_or_measurement_approach":"Incidence rate of Dose Limiting Toxicity (DLT) within the first treatment cycle assessed per NCI CTCAE; DLTs counted among patients in Phase Ib during cycle 1."}
• {"endpoint_text":"- Phase II: to evaluate the ORR, defined as the rate of Complete Response (CR) plus Partial Response (PR) according to RECIST version 1.1, out of the patients who receive at least one dose of treatment and have measurable disease. These results will be calibrated against the ORR in the control arm.","definition_or_measurement_approach":"Objective response rate (ORR) = CR + PR according to RECIST v1.1 assessed by investigators among patients who received ≥1 dose and have measurable disease; results compared/calibrated against control arm ORR."}

Spain

Earliest CTIS Part Ii Submission Date

20-02-2024

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

741

Number Of Sites

24

Number Of Participants

117

Primary sponsor

Full Name

Cantargia AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

PPD (UK) Limited

Responsibilities

[{"code":8}]

Name

PPD Development LP

Responsibilities

[{"code":4}]

Name

PPD Global Central Labs

Responsibilities

[{"id":901035,"code":15,"value":"Sample kits and logistic"}]

Third parties

• {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"[{\"code\":8}]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"[{\"code\":4}]","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Histalim","duties_or_roles":"[{\"code\":4}]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"[{\"id\":901035,\"code\":15,\"value\":\"Sample kits and logistic\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Fundacion Grupo Espanol De Investigacion En Cancer De Mama","duties_or_roles":"[{\"id\":901028,\"code\":1},{\"id\":901029,\"code\":10},{\"id\":901030,\"code\":11},{\"id\":901031,\"code\":12},{\"id\":901032,\"code\":2},{\"id\":901033,\"code\":5},{\"id\":901034,\"code\":6}]","organisation_type":"Patient organisation/association"}