QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety

NCT04233151 | Unknown Phase 3 DMC

• 1 other identifier: QL1203-003
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the treatment effect of QL1203 in combination with mFOLFOX6 compared to Placebo in combination with mFOLFOX6 as first line therapy for metastatic colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival（PFS）

  Progression-free survival (PFS), assessed by blinded independent central review committee, is defined as the time from randomization to disease progression per RECIST v1.1 criteria or death.

  From randomization until disease progression up to 12 months

Study Arms (2)

mFOLFOX6 + QL1203

EXPERIMENTAL

Participants receive QL1203, 6mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity

Drug: QL1203; Drug: mFOLFOX6 regimen

mFOLFOX6 + Placebo

ACTIVE COMPARATOR

Participants received Placebo，6 mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

Drug: Placebo; Drug: mFOLFOX6 regimen

Interventions

QL1203 DRUG

6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.

mFOLFOX6 + QL1203

Placebo DRUG

6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.

mFOLFOX6 + Placebo

mFOLFOX6 regimen DRUG

The mFOLFOX6 regimen is consist of oxaliplatin 85 mg/m\^2 intravenous (IV) infusion on Day 1;leucovorin, 200 mg/m\^2 on Days 1 and 5-fluorouracil 400 mg/m\^2 IV bolus on day 1, then 1200 mg/m\^2/dx2days(total 2400 mg/m\^2 over 46-48 hours) IV continuous infusion. Each cycle was 14 days.

mFOLFOX6 + Placebo; mFOLFOX6 + QL1203

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as metastatic colorectal adenocarcinoma and is not suitable for local treatment such as radical resection, radiotherapy, radiofrequency and so on.
• Man or woman at least 18 years old.
• At least one measurable lesion can be evaluated according to Response Evaluation Criteria In Solid Tumors 1.1（RECIST1.1） criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status should be 0-1 before randomization.
• The level of organ function must meet the requirements before randomization.
• Prior to randomization, the damage caused by other treatments had recovered to \< grade 2 (CTCAE version 4.03).

You may not qualify if:

• Prior systemic or local chemotherapy for colorectal cancer，except in the following cases: the interval between the last dose of neoadjuvant or adjuvant therapy and recurrence\> 6 months。
• Prior epithelial growth factor receptor(EGFR)-targeted drugs for colorectal cancer.
• Presence of central nervous system (CNS) metastases before the informed consent was signed, except for those who had stabilized CNS metastases for more than 4 weeks and had no symptoms after treatment.
• History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment.
• History of interstitial lung disease.
• Existing intestinal obstruction before randomization, active inflammatory bowel disease.
• Patients with non-healing abdominal fistula and gastrointestinal perforation before randomization.
• There were severe active infections or uncontrollable infections that required systemic treatment and could not be enrolled at the decision of the investigator within 14 days before randomization.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Lin Shen, Professor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Weijian Guo, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Kang, CMO

CONTACT

0531-83129659; Xiaoyan.Kang@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: January 20, 2020
• Primary Completion: December 31, 2024
• Study Completion: July 30, 2025
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

CN (2)