A Phase 1 Study of CTIM-76 in Patients with Recurring Ovarian Cancer and Other Advanced Solid Tumors

• Research type

  Research Study

• Full title

  A Phase 1, First-in-Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients with Recurring Ovarian Cancer and Other Advanced Solid Tumors

• IRAS ID

  1013350

• Contact name

  Megan Schaeffer

• Contact email

  mschaeffer@contexttherapeutics.com

• Sponsor organisation

  Context Therapeutics Inc.

• Eudract number

  2025-523968-20

• Clinicaltrials.gov Identifier

  NCT06515613

• Research summary

  This is a phase 1, first-in-human study evaluating the safety, effectiveness, and tolerability of an investigational
  treatment called CTIM-76 in participants with recurring ovarian cancer or other advanced solid tumours. This research
  study is Sponsored by Context Therapeutics Inc.

  This study will involve participants who have tumours that produce a protein called claudin-6 (CLDN6), which is not usually
  present in healthy adults. CTIM-76 is a member of a group of drugs called bispecific antibodies, which are designed to
  target specific features of a particular cancer. CTIM-76 recognises and targets CLDN6, which may offer therapeutic
  benefit to patients. In this study, CTIM-76 will be administered via intravenous infusions once weekly on a 28-day cycle,
  although other schedules may be explored.

  This study consists of two parts:
  - Phase 1a aims to find out the dose of CTIM-76 that is tolerated the best. A low dose of CTIM-76 will be
  administered to an initial group of participants, with gradually increasing doses given to subsequent groups only if the
  prior dose is found to be safe and effective.
  - Phase 1b aims to determine if CTIM-76 helps with preventing the disease from getting worse and to continue
  monitoring the safety of CTIM-76. The doses of CTIM-76 used in Phase 1b will be determined based on the data
  collected from Phase 1a of the study.

  For each participant, there will be a 28 day screening period, an estimated 6 month treatment period, and up-to 24
  month follow-up period. Approximately 90 participants will take part in this study.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  26/EE/0103

• Date of REC Opinion

  5 Mar 2026

• REC opinion

  Further Information Favourable Opinion