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A Phase I/Ib Study to Evaluate the Safety, Tolerability, Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy

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Trial Profile

A Phase I/Ib Study to Evaluate the Safety, Tolerability, Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Aug 2023

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At a glance

  • Drugs Avelumab (Primary) ; GEN 001 (Primary)
  • Indications Carcinoma; Head and neck cancer; Non-small cell lung cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Genome & Company

Most Recent Events

  • 06 Aug 2023 Status changed from recruiting to completed.
  • 16 Nov 2020 According to a Genome and Company media release, following the IND approval from MFDS, it is expected that this MRCT (Multi Regional Clinical Trial) approach will expedite the patient recruitment. Also, it may provide an opportunity for cancer patients in Korea with solid tumors to join the clinical trial. This clinical trial is being conducted simultaneously in Korea and the US.
  • 16 Nov 2020 According to a Genome and Company media release, the investigational new drug (IND) application for this study has been approved by the Korea Ministry of Food and Drug Safety (MFDS) following the IND clearance from the US FDA in this April. As a result, both types of GEN-001 clinical trials, an investigator-initiated trial (Monotherapy) and a sponsor-initiated trial (Combination therapy) are being conducted in Korea.

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