OncoMatch/Clinical Trials/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
Is NCT04300556 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for solid tumor.
Treatment: Farletuzumab ecteribulin · Prednisone · Prednisolone · Dexamethasone · Lenvatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: FOLR1 any tested (testing required; no minimum expression threshold)
Available tumor tissue for FRA expression percent (%) by IHC analysis as assessed at a central laboratory. There is no minimum requirement for FRA expression (%).
Disease stage
Required: Stage IV
advanced, recurrent or metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic anticancer therapy — metastatic
Previously treated with at least one line of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting. [TNBC]
Must have received: systemic therapy — metastatic
participants who have failed previous treatment for metastatic disease [NSCLC adenocarcinoma]
Must have received: platinum-based regimen or immunotherapy-based regimen
Relapsed or failure of at least one platinum-based regimen or one immunotherapy-based regimen [EC]
Must have received: platinum-containing chemotherapy
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) [OC/primary peritoneal/fallopian tube cancer]
Cannot have received: folate receptor targeting agents
Exception: mirvetuximab soravtansine in the setting of FRA >=75%
Participants who received previous treatment with any folate receptor targeting agents, except for mirvetuximab soravtansine in the setting of FRA >=75%
Cannot have received: chest radiotherapy
Exception: chest wall radiation > 2 years before starting study treatment
History of chest radiotherapy. Participants with history of chest wall radiation (example, history of breast cancer) may be permitted if chest wall radiation is documented > 2 years before starting study treatment.
Cannot have received: pneumonectomy
Prior pneumonectomy
Lab requirements
Blood counts
ANC >=1.0*10^9/L (MORAb-202 monotherapy); ANC >=1.5*10^9/L (MORAb-202 plus lenvatinib); Hgb >=9.0 g/dL; Platelet count >=75*10^9/L
Kidney function
Serum creatinine <=1.5 mg/dL or calculated creatinine clearance >=50 mL/min (Cockcroft-Gault formula for Dose Optimization Part B)
Liver function
Total bilirubin <=1.5*ULN except for unconjugated hyperbilirubinemia (e.g., Gilbert's syndrome); ALT and AST <=3*ULN (<=5*ULN with liver metastases); ALP <=3*ULN unless known bone metastases; Albumin >3.0 g/dL
Adequate renal function as evidenced by serum creatinine <=1.5 mg/dL or calculated creatinine clearance >=50 mL/min... Adequate bone marrow function... Adequate liver function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- ACRC/Arizona Clinical Research Center, Inc · Tucson, Arizona
- Universty of Arkansas for Medical Sciences · Little Rock, Arkansas
- Stanford Women's Cancer Center · Palo Alto, California
- University of Miami · Coral Gables, Florida
- Moffitt Cancer Center and Research Institute · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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