An Open-Label Phase 1/2 Trial to Evaluate the Safety, Tolerability, and Efficacy of MORAb 202 in Subjects with Selected Tumor Types.
- Conditions
- Solid tumors in 4 tumor types: platinum resistant ovarian cancer, triple-negative breast cancer (TNBC), endometrial cancer (EC), and non-small cell lung cancer adenocarcinomaNSCLC).MedDRA version: 21.0Level: PTClassification code: 10014733Term: Endometrial cancer Class: 100000004864MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506868-14-00
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 112
1.Aged =18 years 2.For Dose-Escalation: Females (TNBC, EC and OC) or males/females (NSCLC adenocarcinoma). Subjects with the following disease characteristics: a.TNBC: Histologically confirmed diagnosis of metastatic TNBC (ie, estrogen receptor (ER) negative/progesterone receptor negative/ human epidermal growth factor receptor 2 (HER2) negative (defined as IHC <2+ or fluorescence in situ hybridization (FISH) negative) breast cancer). Previously treated with at least one line of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting. b.NSCLC adenocarcinoma: Histologically or cytologically confirmed metastatic NSCLC adenocarcinoma: subjects who have failed previous treatment for metastatic disease, are not indicated or failed epidermal growth factor receptor (EGFR)-, ALK-, BRAF- or ROS1-targeted therapy, and for whom no alternative standard therapy exists. c.EC: Histologically confirmed diagnosis of advanced, recurrent or metastatic EC. Relapsed or failure of at least one platinum-based regimen or one immunotherapy-based regimen. d.Ovarian cancer or primary peritoneal cancer or fallopian tube cancer: Histologically confirmed diagnosis of high grade serous epithelial OC or primary peritoneal cancer or fallopian tube cancer. Subjects must have platinum-resistant disease (defined as progression within 6 months after the last dose of at least 4 cycles of the last platinum containing chemotherapy regimen) received up to 4 lines of systemic therapy post development of platinum resistance. For Dose-Confirmation and Dose Optimization: Note: Only subjects with histologically confirmed diagnosis of advanced, recurrent, or metastatic EC will be enrolled at sites in France. 3.Available tumor tissue for FRA expression (%) by IHC analysis as assessed at a central lab. 4.Radiological disease progression on or after the most recent therapy by investigator assessment. 5.Measurable disease as set out in the protocol 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 7.Subjects who are expected to survive a minimum of 3 months after the first administration of the study drug. 8.Adequate renal function as defined in the protocol.9.Adequate bone marrow function as defined in the protocol. 10.Adequate liver function as defined in the protocol, 11.Subjects must undergo a washout period required from the end of prior treatment to the first administration of the study drug. 12.Patients with a history of deep vein thrombosis (DVT) within 3 months of enrollment must be on a stable dose of anticoagulation as demonstrated by appropriate laboratory parameters (depending on the anticoagulant agent) for a minimum of 2 weeks prior to starting study treatment. Anticoagulation must continue while on the study treatment. 13.Patients at risk for DVT secondary to central venous catheters or with past medical history of DVT or clinical symptoms suggestive of DVT must have venous Doppler ultrasonography to rule out DVT during the screening period and prior to initiation of study treatment. 14.If a subject has undergone major surgery, the subject must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. 15.Resolution of anticancer therapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (Grade =2), anemia (Hgb =9.0 g/dL), and alopecia (any grade). 16.Subject must be willing and able
1-Subjects with endometrial leiomyosarcoma, endometrial stromal sarcoma other soft tissue sarcoma histology. 2-Subjects who received previous treatment with any folate receptor targeting agents. 3-Subjects with platinum refractory OC. 4-Currently enrolled in another clinical study or used any investigational drug or device. 5-Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 2 weeks before starting treatment in this study. 6-Diagnosed with meningeal carcinomatosis. 7-Any other invasive malignancy that required treatment (other than definitive surgery) or has shown evidence of recurrence/progression (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 2 years prior to starting study treatment. 8-Significant cardiovascular impairment. 9-Clinically significant ECG abnormality. 10-Known to be HIV positive. 11-Active viral hepatitis (B or C as demonstrated by positive serology). 12-Females who are breastfeeding or pregnant at Screening or Baseline. 13-Females of childbearing potential who: •within 28 days before study entry, did not use a highly effective method of contraception, as set up in the protocol 14-For Dose-Escalation only: Males who have not had a successful vasectomy or they and their female partners do not meet the criteria above. 15-Pulmonary Function Test (PFT) abnormalities: FEV1/FVC <0.7, FEV1 or FVC <80%, DLCO <80%or less than the lower limit of normal according to local institutional standards. 16-Current ILD/pneumonitis, or ILD/pneumonitis is suspected at Screening or history ILD/pneumonitis of any severity including ILD/pneumonitis from prior anticancer therapy. 17-Current infectious pneumonia, history of viral pneumonia with evidence of persistent radiologic abnormalities. 18-Lung-specific clinically significant illnesses and restrictive lung disease or currently receiving any medication that is associated with a clinically significant risk of developing ILD. 19-Clinically significant pleural or pericardial effusion requiring drainage or ascites requiring peritoneal shunt. 20-Prior pneumonectomy., 21-History of chest radiotherapy. Subjects with history of chest wall radiation (eg, history of breast cancer) may be permitted if chest wall radiation is documented > 2 years before starting study treatment. 22-Any autoimmune, connective tissue, or inflammatory disorders where there is documented (or suspicion of) pulmonary involvement. 23-A known history of active TB (bacillus tuberculosis). 24-Scheduled for surgery during the study, other than minor surgery which would not delay study treatment. 25-An active clinically significant (in the opinion of the Investigator) infection requiring systemic therapy within 2 weeks prior to the first dose of study drug. 26-Administration of a live, attenuated vaccine within 4 weeks prior to the first dose of study drug, or anticipation that such a live attenuated vaccine will be required during the study. 27-Any prior hypersensitivity to monoclonal antibodies and/or contraindication to the receipt of corticosteroids or any of the excipients 28-Known intolerance to either of the components of the study drug. 29-Any medical or other condition which, in the opinion of the investigator would preclude the subject's participation in the clinical study. 30-Receiving any medication prohibited in c
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method