None listed
Conditions
Interventions
Drug : Patritumab deruxtecan will be dosed at 5.6mg/kg as an itravenous (IV) infusion administered on Day 1 of each 21-day cycle. Dose reductions or interruptions, and initiation of supportive care, a
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have signed and dated the tumor tissue informed consent and the main informed consent form (ICF) prior to initiation of any study-specific eligibility verification procedures. Male and female patients 18 years of age or older (if the legal age for self-consent to participate in a clinical trial is higher than 18 years of age, follow local legal and regulatory requirements) -Patients with histologically or cytologically proven locally advanced/metastatic solid tumors that are not curable with curative surgery or radiation therapy. -Patients with documented presence of NRG1 fusions detected by TruSightOncology-500 or Guardant-360 or FoundationOne®CDx (F1CDx), including but not limited to, in tumor tissue or blood specimens. -At least 1 confirmed measurable lesion as assessed by the investigator according to RECIST v1.1 -Eastern Cooperative Oncology Group (ECOG) performance status 0-1 at screening - Adequate bone marrow reserve and organ function based on local laboratory test data within 14 days prior to Day 1 of Cycle 1: -Platelet count: = 100,000/mm3 or = 100×109/L (platelet transfusions are not allowed within 14 days prior to Day 1 of cycle 1 to meet eligibility criteria) -Hemoglobin: = 9.0 g/dL (transfusion and/or growth factor supplementation is allowed) -Absolute neutrophil count (ANC): =1500/mm3 or = 1.5×109/L -CrCl serum creatinine (SCr) or creatinine clearance (CrCL): SCr =1.5 × upper limit of normal (ULN) or CrCl = 30 mL/min, calculated by the CockcroftGault formula or measured directly -Asparaginic acid aminotransferase (AST)/alanine aminotransferase (ALT): = 3×ULN (= 5×ULN for patients with liver metastases) -Total bilirubin: = 1.5×ULN, in the absence of liver metastases. (= 3×ULN for patients with proven Gilbert syndrome [hyperbilirubinemia] or liver metastases) -Serum albumin: = 2.5 g/dL -Prothrombin time (PT) or PT-international normalized ratio (INR) and activated partial thromboplastin time (aPTT)/PTT: = 1.5 × ULN, except for patients on coumarin derivative anticoagulants or other similar anticoagulants whose PT-INR values are within the therapeutic range as deemed appropriate by the investigator.
Exclusion criteria
Exclusion criteria: -Patients with a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis) or currently suffering from ILD or with suspected presence of such disease on imaging studies performed at screening. -Clinically significant respiratory failure (as assessed by the Investigator) due to concomitant lung disease, including but not limited to: o Any underlying pulmonary disorder (e.g. pulmonary embolism within 3 months prior to study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pulmonary effusion) o Any autoimmune/connective tissue/inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); or history of total pneumonectomy Chronic use of systemically active corticosteroids (prednisone at doses greater than 10 mg or equivalent), anti-inflammatory drugs, or other immunosuppressive agents in any form prior to enrollment. Patients who require the use of bronchodilators, inhaled/external steroids, or topical steroid injections may participate in the study. -Evidence of leptomeningeal disease -Evidence of clinically active spinal cord compression or brain metastasis -Prior to Day 1 of cycle 1, inadequate extracorporeal emptying, defined as o Less than 14 days of whole brain radiotherapy or less than 7 days of brain stereotactic radiotherapy o Less than 14 days or 5 times the half-life (whichever is longer) of any cytotoxic chemotherapeutic agent, investigational drug, or other anticancer agent (other than an EGFR TKI) included in a prior chemotherapy regimen or clinical trial. longer) o Monoclonal antibodies other than immune checkpoint inhibitors, including bevacizumab (anti-VEGF) or cetuximab (anti-EGFR), for less than 28 days o Immune checkpoint inhibitors for less than 21 days o Major surgery (excluding vascular access device placement) < 28 days o Less than 28 days of radiation therapy to greater than 30% of the bone marrow or a large area, or less than 14 days of hyperfractionated radiation therapy o Chloroquine or hydroxychloroquine less than 14 days -Previous administration of human epithelial growth factor receptor type 3 (HER3) antibodies or topoisomerase I inhibitors alone. -Previous administration of an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor. -Unresolved toxicity from prior anticancer therapy. Unresolved toxicity is defined as Grade 1 or less according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 or unresolved toxicity at baseline, except alopecia. Patients with chronic grade 2 toxicity may be eligible for study participation at the discretion of the investigator. -History of other active malignancy within 3 years prior to enrollment, with the following exceptions o Adequately treated non-melanoma skin cancer. o Superficial bladder cancer (Ta, Tis, T1) o Well-differentiated thyroid cancer o Adequately treated cervical intraepithelial carcinoma o Low-risk, non-metastatic prostate cancer (Gleason score less than 7 and has been treated locally or is currently on active surveillance) o Other curatively treated carcinoma in situ -Uncontrolled or significant cardiovascular disease present prior to Day 1 of Cycle 1 -Currently active hepatitis B and/or C infection, including serologic evidence of viral infection within 28 days prior to Day 1 of Cycle 1 -Patients with human i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR);Progression-free survival(PFS);Disease-control rate(DCR);Best percentage change in the SoD(sum of diameters) of measurable tumors;Overall survival(OS);Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactSe-Hoon Lee
Samsung Medical Center
Outcome results
None listed