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
1 other identifier
interventional
71
1 country
2
Brief Summary
In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2020
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2020
CompletedFirst Submitted
Initial submission to the registry
March 24, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedApril 6, 2023
March 1, 2023
2.7 years
March 24, 2023
March 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
QL1604
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The First Affliated Hospital of Nanchang University
Nanchang, China
Fudan University Shanghai Cancer Center
Shanghai, China
Related Publications (1)
Xiong J, Ouyang W, Yang M, Gao Z, Zhou H, Lou H, Guo Y, Xu Z, Zheng L, Liu Y, Wang Z, Sun P, Niyazi H, Wang J, Chen Y, Zhang B, Li L, Kang X, Guo W. Efficacy and Safety of Iparomlimab, an Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors: A Phase 1c Study. Adv Ther. 2024 Nov;41(11):4153-4171. doi: 10.1007/s12325-024-02981-z. Epub 2024 Sep 14.
PMID: 39276185DERIVED
Study Officials
- STUDY CHAIR
Weijian Guo, PhD
Fudan University
- STUDY CHAIR
Jianping Xiong, PhD
The First Affliated Hospital of Nanchang University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2023
First Posted
April 6, 2023
Study Start
July 20, 2020
Primary Completion
April 15, 2023
Study Completion
December 15, 2023
Last Updated
April 6, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share