QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT05799820
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • QL1706 — DRUG
    5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
  • Bevacizumab — DRUG
    7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
  • Oxaliplatin injection — DRUG
    130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
  • Capecitabine — DRUG
    1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle

Study Details

This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.

Key Dates

First listed
Apr 5, 2023
Start date
Sep 29, 2022
Status verified
Mar 2023
Primary completion
Mar 30, 2024
Completion
Sep 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706
  • Experimental: QL1706 in combination with bevacizumab and XELOX

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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