A Phase I Study of QL1604 for Advanced Solid Tumors

A Phase I Clinical Study to Evaluate Safety、 Tolerability, and Pharmacokinetics of QL1604 for the Treatment of Advanced Solid Tumors - A Phase Ic Preliminary Efficacy Expansion Study

In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: QL1604

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Nanchang, China
    • The First Affliated Hospital Of Nanchang University
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• 18-75 years;
• At least one measureable lesion as defined per RECIST Version (v) 1.1
• Histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis
• Adequate important organ function

Key Exclusion Criteria:

• Active autoimmune disease orautoimmune disease history
• Meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of > 10 mg/day or equivalent hormone) for more than 2 weeks)
• Known hypersensitivity to protein macromolecules, and/or any of QL1604 excipients
• Radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks)
• Active hepaititis B or C infection
• Both HBsAg and anti-HCV Ab positive

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL1604	Drug: QL1604; QL1604 3 mg/kg Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.	up to 2 years

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Weijian Guo, PhD, Fudan University; Study Chair: Jianping Xiong, PhD, The First Affliated Hospital Of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Anticipated): April 15, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: QL1604-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No