A Phase 2 Study of MORAb-202 in Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

JRCT ID: jRCT2071220106

Registered date:12/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
• Date of first enrollment: 01/03/2023
• Target sample size: 90
• Countries of recruitment: Australia,Japan,Belgium,Japan,Chile,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Spain,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

Experimental: Arm B: MORAb-202, Specified dose on specified days
Experimental: Arm C: Investigator's Choice Chemotherapy with Paclitaxel or Pegylated Liposomal Doxorubicin(PLD), Topotecan, Specified dose on specified days

Outcome(s)

Primary Outcome

-Objective Response Rate (ORR) by RECIST v1.1 per Investigator Assessment
-Proportion of participants with treatment-related adverse events(TRAE) leading to discontinuation

Secondary Outcome

-PFS by RECIST v1.1 per Investigator Assessment
-DCR by RECIST v1.1 per Investigator Assessment
-DoR by RECIST v1.1 per Investigator Assessment
-Incidence and severity of the following safety events will be evaluated: adverse events (AEs)/serious adverse events (SAEs), AEs leading to discontinuation, TRAEs leading to discontinuation, AEs of special interest (AESIs), deaths, and laboratory abnormalities

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

-Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
-Platinum-resistant disease, defined as:
For participants who had only 1 line of platinum-based therapy: progression between > 1 month and <=6 months after the last dose of platinum-based therapy of at least 4 cycles.
For participants who had 2 or 3 lines of platinum-based therapy: progression <= 6 months after the last dose of platinum-based therapy.
Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance.
-Disease progression per RECIST v1.1 (by investigator assessment) of at least 1 measurable lesion on or after the most recent therapy.
-Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) or newly-obtained biopsies must be available for FRa assessment prior to randomization.
-Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Exclude criteria

-Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer.
-Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen.
-Pulmonary function test (PFT) abnormalities: FEV1 < 70% or FVC < 60%, and DLCO < 80%.
-Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy.
-Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
-Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
-Has any prior severe hypersensitivity (>= Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).
-History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C.

Related Information

• Primary Sponsor: Joseph Nacson
• Secondary Sponsor: Eisai Co., Ltd.
• Secondary ID(s): NCT05613088