A Phase 1 Study of MORAb-202 in Subjects With Solid Tumors

Trial ID # NCT03386942
Phase I
Drug Class Antibody Drug Conjugates: FRalpha
Drug Name Farletuzumab ecteribulin
Alternate Drug Names MORAb-202
Drugs in Trial Farletuzumab ecteribulin
Eligible Participant

Platinum resistant ovarian cancer

Patients Enrolled

45, median 3 prior therapies

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, PFS, OS, evaluated per RECIST


FRalpha+ (>5% cells with FRalpha IHC +1, +2 or +3)


MORAb-202 0.9 mg/kg (n=24):

ORR: 25% (1CR, 5PR)
DCR: 66.7% (1CR, 5PR, 10SD)
DoR: 10.6 months
PFS: 6.7 months
OS: 10.5 months

MORAb-202 1.2 mg/kg (n=21):

ORR: 52.4% (11PR)
DCR: 95.2% (11PR, 9SD)
DoR: 7.6 months
PFS: 8.2 months

Clinically Significant Adverse Events

MORAb-202 0.9 mg/kg vs 1.2 mg/kg:
Serious AE: respiratory events - pneumonitis, interstitial lung disease (8.3 vs 14.3%)
Grade 3-4 AE: overall (33.3 vs 28.6%)


Anti-tumor activity is seen with both the farletuzumab ecteribulin (MORAb-202) 0.9 mg/kg and 1.2 mg/kg doses and efficacy is observed irrespective of FRalpha-expression levels. Ongoing body surface area-based dosing is predicted to lower the exposure-dependent pneumonits/interstitial lung disease risk


Hayato S et al. Dose optimization for MORAb-202, an antibody-drug conjugate (ADC) highly selective for folate receptor-alpha, using population pharmacokinetic (PPK) and exposure-response (E-R) efficacy and safety analyses. J Clin Oncol 40, 2022 (suppl 16; abstr 3090)

Hayato S et al. Poster

Nishio S et al. Safety and efficacy of MORAb-202 in patients (pts) with platinum-resistant ovarian cancer (PROC): Results from the expansion part of a phase 1 trial. J Clin Oncol 40, 2022 (suppl 16; abstr 5513)

Nishio S et al. Poster

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