- A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types — Recruiting • Phase I • Oncology • NCT04300556.
- Drug Being Tested: Farletuzumab ecteribulin (MORAb-202), a folate receptor alpha (FRα)-targeting antibody-drug conjugate designed to deliver chemotherapy directly to cancer cells expressing this receptor.
- Patient Eligibility: Participants with selected FRα-positive tumour types including ovarian cancer, endometrial cancer, and other solid malignancies; study uses dose-escalation methodology to establish safety parameters and determine recommended Phase 2 dosing.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin…
- : 1. Aged >=18 years 2. For Dose-Escalation: Females (TNBC, EC and OC) or males/females (NSCLC, adenocarcinoma). Participants with the following disease characteristics: Participants with the following tumor types, each as a separate arm: 1. TNBC: Histologically confirmed diagnosis of metastatic TNBC (that is, estrogen receptor (ER) negative/progesterone receptor negative/ human epidermal growth factor receptor 2 (HER2) negative (defined as immunohistochemistry (IHC) less than () 1 month and less than or equal to (1.0 centimeter (cm) in long axis diameter for non-lymph nodes or >1.5 cm in short axis diameter for lymph nodes that is serially measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using either computed tomography (CT) or magnetic resonance imaging (MRI), * Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of PD based on RECIST 1.1 to be deemed a target lesion. 6. ECOG PS of 0 or 1.
- Participants who are expected to survive a minimum of 3 months after the first administration of the study drug. 8. Adequate renal function as evidenced by serum creatinine less than or equal to (=50 milliliter per (mL) /minute according to a 12…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.