* Phase1/2 Trial of MORAb-202 in patients with selected tumour types

• Research type

  Research Study

• Full title

  A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) in Subjects With Selected Tumor Types

• IRAS ID

  292422

• Contact name

  Andrew Clamp

• Contact email

  andrew.clamp@nhs.net

• Sponsor organisation

  Eisai Inc.

• Eudract number

  2019-003600-12

• Clinicaltrials.gov Identifier

  NCT04300556

• Duration of Study in the UK

  2 years, 7 months, 1 days

• Research summary

  This study is being conducted on 4 cancer types: Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Ovarian Cancer and Endometrial Cancer.
  It involves 2 stages, a dose escalation stage to determine a safe and tolerable dose and an expansion stage which will determine how safe and effective the drug is at fighting cancer.
  The study drug works only for some types of tumours which have a specific receptor on the cell surface, this receptor allows the study drug to enter inside the tumour and kills the cancer cell.

  Dose Escalation Part:
  Participants will be enrolled into groups of 6.The first group will receive a low dose and if this does not cause any severe side effects a new group will be enrolled and the dose will be increased for each new group until the highest safe dose is achieved.

  Expansion Part:
  This will start with a 28day screening period where eligible participants will be assessed on their cancer and entered into the open label study.
  Participants will receive 21day treatment cycles that will repeat until disease progression, study drug intolerance or the participant withdrawal.

  All participants will receive the study drug on day one of each 21day cycle.

  Participants will be evaluated to determine the effect of the new drug on their cancer via CT/MRI scans every 6 weeks for the first 24 weeks. A bone scan may be completed every 24 weeks.

  Participants will continue treatment until the investigator documents any unacceptable side effects, worsening of the cancer, death, initiation of another anti-cancer therapy or the participant withdraws consent.

  Each participant will undergo a 28 day safety follow-up and a long term follow-up every 12 weeks for 3 years.

  The study is Sponsored by Eisai Inc, Approx. 36 participants will participate in the Dose Escalation and 80-160 in the Expansion Study worldwide. With 20 participants in the UK.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/FT/0039

• Date of REC Opinion

  7 May 2021

• REC opinion

  Further Information Favourable Opinion