First-in-Human Trial of GEN1042 in Malignant Solid Tumours

• Research type

  Research Study

• Full title

  A First-in-Human, Open-label, Dose-escalation Trial with Expansion Cohorts to Evaluate Safety of GEN1042 in Subjects with Malignant Solid Tumors

• IRAS ID

  263292

• Contact name

  Juanita S Lopez

• Contact email

  Juanita.Lopez@icr.ac.uk

• Sponsor organisation

  Genmab A/S

• Eudract number

  2018-003716-47

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT04083599

• Duration of Study in the UK

  3 years, 0 months, 31 days

• Research summary

  The drug being researched is an investigational drug called GEN1042. GEN1042 works by using the body’s own immune system to attack cancer. Some tumours can hide from the immune system by binding with T cells and deactivating them. T cells are a specific type of cell in your immune system that move throughout your body to detect and fight infections and diseases including cancer.
  
  To overcome this, GEN1042 is specifically designed to enhance or reactivate tumour-specific T cells under certain conditions to attack the cancer cells.

  The trial consists of two consecutive parts; a dose-escalation part (phase I, first-in-human (FIH)) and an expansion part (phase IIa).

  The dose escalation will evaluate GEN1042 in participants with non-central nervous system solid malignant tumours to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) (how much drug can be given without unacceptable side effects) and/or recommended Phase 2 dose.

  The expansion will provide further data regarding the safety and initial efficacy information using the selected dose/schedule and is planned to enrol participants with relapsed or refractory, advanced and/or metastatic melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC).

  The medical need is high for innovative anti-cancer therapies with improved efficacy and safety profiles, including therapies for patients with the aforementioned cancer types.

  This trial will take place in different countries. Approximately 60 participants across 6 sites are expected to take part in the dose escalation part for at least three years and up to 66 participants across approximately 20 sites are planned to be enrolled in the expansion.

  The participants may continue to receive treatment with GEN1042 until their disease progresses.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  19/LO/1288

• Date of REC Opinion

  31 Oct 2019

• REC opinion

  Further Information Favourable Opinion