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Recruiting NCT04300556

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

Conditions: Solid Tumor

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 182
Sponsor: Eisai Inc.

Location: ACRC/Arizona Clinical Research Center, Inc Tucson Arizona

Summary

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 (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \[OC and EC participants\] and Part B \[OC only\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.

Eligibility Criteria

Inclusion Criteria: 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. 7. 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 or 24 hour urine collection. For Dose Optimization Part B, adequate renal function as evidenced by calculated creatinine clearance \>=50 milliliters per minute (mL/min) by Cockcroft-Gault formula. 9. Adequate bone marrow function, as evidenced by: * Absolute neutrophil count (ANC) \>=1.0\*10\^9 per liter (/L) (MORAb-202 monotherapy cohorts only) * ANC \>=1.5\*10\^9/L (MORAb-202 plus lenvatinib cohorts) * Hemoglobin (Hgb) \>=9.0 gram per deciliter (g/dL) * Platelet count \>=75\*10\^9/L Growth factors or transfusions as per institutional practice, are allowed if needed to achieve the above values. Growth factor and platelet transfusion should not be used within 7 days of initiation of study treatment. 10. Adequate liver function, as evidenced by: * Total bilirubin \500 milliseconds \[ms\]). A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QTcF. For participants enrolled in the MORAb-202 plus lenvatinib cohorts, prolongation of the QTcF interval to \>480 ms. 10. Known to be Human Immunodeficiency Virus (HIV) positive. Testing at entry not required. 11. Active viral hepatitis (B or C as demonstrated by positive serology). Testing at entry if there are no symptoms or history is not required unless as per local requirements. 12. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin \[ß-hCG\] or human chorionic gonadotropin \[hCG\]) with a minimum sensitivity of 25 International units per liter (IU/L) or equivalent units of ß-hCG \[or hCG\]. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first administration of the study drug. 13. Females of childbearing potential who * within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following: * total abstinence (if it is their preferred and usual lifestyle)\* * an intrauterine device or intrauterine hormone-releasing system (IUS) * a contraceptive implant * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). Participants using an oral contraceptive (participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 7 months (5\*half-life plus 180 days) after study drug discontinuation) * bilateral tubal occlusion * have a vasectomized partner with confirmed azoospermia * do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 7 months (5\*half-life plus 180 days) after study drug discontinuation. For sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). \*Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. 14. For Dose-Escalation only: Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 7 months (5\*half-life plus 180 days) after study drug discontinuation). If the female partner is pregnant, then males who do not agree to use latex or synthetic condoms throughout the study period and for 4 months (5\*half-life plus 90 days) after study drug discontinuation. No sperm donation is allowed during the study period and for 4 months (5\*half-life plus 90 days) after study drug discontinuation. 15. Pulmonary Function Test (PFT) abnormalities: FEV1/FVC \

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Source: ClinicalTrials.gov (NCT04300556). StuddyBuddy aggregates publicly available trial information.