NCT05239650

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
6mo left

Started Jul 2022

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jul 2022Oct 2026

First Submitted

Initial submission to the registry

February 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Expected
Last Updated

May 3, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

February 7, 2022

Last Update Submit

May 1, 2022

Conditions

CRC

Outcome Measures

Primary Outcomes (2)

  • ORR

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

    up to 3 years

  • PFS

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

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

Secondary Outcomes (1)

  • OS

    up to 5 years

Study Arms (2)

A：1L treatment

EXPERIMENTAL

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

Drug: HLX07Drug: HLX10Drug: mFOLFOX6

B：≥2L treatment

EXPERIMENTAL

HLX07 \*1000 mg monotherapy,IV, Q2W

Drug: HLX07

Interventions

HLX07DRUG

1000mg

A：1L treatmentB：≥2L treatment
HLX10DRUG

200mg

A：1L treatment
mFOLFOX6DRUG

OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2

A：1L treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

HLX07

Study Officials

  • Peng Junjie

    Fudan University Affiliated Oncology Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Junjie

CONTACT

: 86021-64175590junjiepeng67@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 15, 2022

Study Start

July 15, 2022

Primary Completion

October 15, 2025

Study Completion (Estimated)

October 15, 2026

Last Updated

May 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share