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Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC

Sponsor
Shanghai Henlius Biotech (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05239650
Collaborator
(none)
50
Enrollment
2
Arms
51
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer
Anticipated Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Oct 15, 2025
Anticipated Study Completion Date :
Oct 15, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: A：1L treatment

HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W

Drug: HLX07
1000mg

Drug: HLX10
200mg

Drug: mFOLFOX6
OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2
Experimental: B：≥2L treatment

HLX07 *1000 mg monotherapy,IV, Q2W

Drug: HLX07
1000mg

Outcome Measures

Primary Outcome Measures

  1. ORR [up to 3 years]

    Objective response rate (assessed by investigator per RECIST V1.1)

  2. PFS [: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years]

    Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 )

Secondary Outcome Measures

  1. OS [up to 5 years]

    Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age>=18Y and ≤75Y

  • Good Organ Function

  • Expected survival time ≥ 3 months

  • mCRC that have been diagnosed histologically

  • KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue

  • ECOG score 0-1;

Exclusion Criteria:

  • HIV infection

  • Active clinical severe infection;

  • A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Henlius Biotech

Investigators

  • Principal Investigator: Peng Junjie, Fudan University Affiliated Oncology Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Henlius Biotech
ClinicalTrials.gov Identifier:
NCT05239650
Other Study ID Numbers:
  • HLX07-mCRC201
First Posted:
Feb 15, 2022
Last Update Posted:
May 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 3, 2022