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A Phase I Study of QL1604 for Advanced Solid Tumors

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05801094
Collaborator
(none)
71
Enrollment
2
Locations
1
Arm
40.8
Anticipated Duration (Months)
35.5
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 20, 2020
Anticipated Primary Completion Date :
Apr 15, 2023
Anticipated Study Completion Date :
Dec 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: QL1604

Drug: QL1604
QL1604 3 mg/kg Q3W

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [up to 2 years]

    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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affliated Hospital of Nanchang University Nanchang China
2 Fudan University Shanghai Cancer Center Shanghai China

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05801094
Other Study ID Numbers:
  • QL1604-002
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Mar 1, 2023
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
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Apr 6, 2023