2023-08-02T00:00:00.000+10:00
Ongoing

MORab-202 CA116-001

MORab-202 CA116-001
Neoplasms, Ovarian cancer

Description A phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, vs. Investigator's Choice Chemotherapy in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer.

Description A phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, vs. Investigator's Choice Chemotherapy in Women with Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer.

Trial overview

Topic

Neoplasms, ovarian cancer

Eligibility criteria

Inclusion 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 FRα assessment prior to randomization.
  • Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1.

Exclusion criteria:

Medical Conditions

  • Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumours 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.
  • Physical and Laboratory Test Findings
  • 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.
  • Allergies and Adverse Drug Reactions
  • Has any prior severe hypersensitivity (= Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients
  • History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C.
  • Other protocol-defined inclusion/exclusion criteria apply.
Study details

The purpose of the study is to assess the safety, tolerability, and efficacy of Farletuzumab Ecteribulin (MORAb-202) and compare it to Investigator's Choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.

Further information

For more information regarding this clinical trial click here.

Location
North Shore :::

Thank you for submitting.

We will be in touch within 24 hours

An unexpected error has occurred.

You will need to complete the form again, sorry for the inconvenience.

How can we help?

If you have a medical emergency please call 000. If you have an urgent request and would like to speak to our staff, please contact one of our centres directly.

* Indicates a required field.