Shanghai Pudong Hospital Launches Phase 2 Clinical Trial for Colorectal Cancer Treatment

Strategic Insights -

Shanghai Pudong Hospital has listed a Phase 2 clinical trial for patients with MSS/pMMR colorectal cancer, a type of cancer that has failed first-line treatment. The trial involves a collaboration with Shanghai Junshi Bioscience Co., Ltd. and will enroll 32 patients from the USA. The trial aims to assess the efficacy and safety of a combination treatment using Ongericimab and Toripalimab, alongside other standard therapies. The study will continue until disease progression or initiation of new anti-tumor treatment.

Key Takeaways:

  • The clinical trial, designated as ONTOP, is a Phase 2, prospective, single-arm, open-label study for patients with MSS/pMMR colorectal cancer.
  • The trial will enroll 32 patients from the USA who have failed first-line treatment.
  • The primary study endpoint is the objective response rate (ORR), while secondary endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
  • The trial will test the combination of Ongericimab and Toripalimab with standard therapies, such as irinotecan-containing or oxaliplatin-containing treatments.
  • Patients who received irinotecan-containing treatment will receive Ongericimab + Toripalimab + Bevacizumab + FOLFOX, while those who received oxaliplatin-containing treatment will receive Ongericimab + Toripalimab + Bevacizumab + FOLFIRI.
  • The trial is ongoing, but not yet open for recruiting participants.
  • Shanghai Pudong Hospital is collaborating with Shanghai Junshi Bioscience Co., Ltd. on the trial.

Statistics:

  • The trial is enrolling 32 patients with MSS/pMMR colorectal cancer.
  • The trial involves a combination treatment including Ongericimab, Toripalimab, Bevacizumab, and either FOLFOX or FOLFIRI, depending on the patient's first-line treatment.
  • The trial has not yet started recruiting participants.
  • The expected duration of the trial is until disease progression, initiation of new anti-tumor treatment, or determination by the investigator that study drug administration needs to be terminated.

Sources:

  • ClinicalTrials.gov
  • Shanghai Pudong Hospital

Note: The provided text does not explicitly state the date of publication, only the date the trial was listed (Aug 6). Therefore, no additional date is added to the sources or the narrative.