Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR/MSS Colorectal Cancer: a Single-arm Phase II Trial

Sponsor
Shanghai Pudong Hospital
Study ID
NCT07106034
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The ONTOP study is a prospective, single-arm, open-label phase II clinical trial. A total of 32 patients with advanced MSS/pMMR colorectal cancer who have failed first-line treatment will receive second-line standard treatment combined with Ongericimab and toripalimab. Among them, patients who received irinotecan-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFOX. Patients who received oxaliplatin-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFIRI. Treatment will continue until disease progression, initiation of new anti-tumor treatment, active request of the subject, or determination by the investigator that study drug administration needs to be terminated. The primary study endpoint is the objective response rate (ORR), and the secondary study endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety, etc.

Key Dates

First listed
Aug 6, 2025
Start date
Aug 31, 2025
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Second-line standard treatment combined with Ongericimab and toripalimab.
    If first line treatment with irinotecan-containing regimen: Ongrezicimab + Toripalimab + Bevacizumab + FOLFOX, Q2W If first line treatment with oxaliplatin-containing regimen: Ongrezicimab + Toripalimab + Bevacizumab + FOLFIRI, Q2W In addition, the period of 21 days after the first administration is defined as the DLT observation period.

Primary Outcome Measure

overall response rate [ Time Frame: Two years ]

Central Contacts

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