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 (Jun 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
Treatments studied
Targeted therapy
Other
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 →Frequently asked questions
Is NCT04300556 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior folate receptor targeting agents, chest radiotherapy, pneumonectomy disqualifies patients from enrollment.
Does this trial require FOLR1?
Yes, FOLR1 any tested is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify