A Study of SEA-CD40 Given with Other Drugs in Cancers

• Research type

  Research Study

• Full title

  An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies

• IRAS ID

  306266

• Contact name

  Anna Minchom

• Contact email

  anna.minchom@icr.ac.uk

• Sponsor organisation

  Seagen Inc.

• Eudract number

  2021-002037-42

• Clinicaltrials.gov Identifier

  NCT04993677

• Clinicaltrials.gov Identifier

  156290, IND

• Duration of Study in the UK

  3 years, 9 months, 0 days

• Research summary

  Study SGNS40-002 is an open-label, phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies.
  SEA-CD40 was designed to find and stick to cancer cells and some cells in the body that are part of the immune system. The immune system helps protect from getting sick. When SEA-CD40 sticks to cells that are part of the immune system, it can help the immune system kill cancer cells.

  The study is constituted of screening/baseline, treatment and follow up period.
  During the screening period, participants will undergo tests and procedures to see if they are eligible to be in the study.
  During the treatment period; participants who achieve stable disease (SD) or better may continue study treatment for 2 years or until unacceptable toxicity, confirmed disease progression, withdrawal of consent, or study termination, whichever occurs first.

  Antitumor activity will be assessed by radiographic tumour imaging at protocol-specified time points. Response assessment for primary and secondary efficacy endpoints will be evaluated by the investigator using RECIST v1.1. Computed tomography (CT) scans and/or magnetic resonance imaging (MRI) will be used for the radiographic tumour imaging.

  Blood plasma and serum will be collected for the Pharmacokinetic and Immunogenicity Assessments

  The study will enrol male and female adult participants with selected solid tumour who will be assigned to different treatment cohorts as per the underlying disease:
  #Cohorts 1: Participants with relapsed/refractory melanoma
  #Cohort 2 : Participants with uveal melanoma
  #Cohort 3: Participants with programmed cell death protein 1 (PD-(L)1)-naïve melanoma
  #Cohort 4: Participants with Nonsquamous Non-Small Cell Lung Cancer (NSCLC); PD-L1 with 1-49% tumour proportion score
  #Cohort 5: Participants with Nonsquamous NSCLC; PD-L1 with <1% tumour proportion score

  A total of approximately 200 participants may be enrolled in the study.
  A safety monitoring committee (SMC) will monitor the safety of participants.

  For cohorts 1, 2 and 3(melanoma), initially, up to 15 subjects may enrol in each cohort before an interim safety and efficacy analyses will be performed. Cohorts may continue to enrol up to an additional 25 participants, for a total of up to approximately 40 participants in each cohort.
  For cohorts 4 and 5 (NSCLC), initially, 6 participants will be enrolled across the 2 cohorts; safety will be assessed after the first treatment cycle.

  Cohorts 1, 2 and 3 will received SEA-CD40 and pembrolizumab.
  Cohorts 4 and 5 will receive SEA-CD40, carboplatin, pemetrexed and pembrolizumab.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0822

• Date of REC Opinion

  22 Dec 2021

• REC opinion

  Further Information Favourable Opinion