A Phase I Study of QL1604 for Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05801094
• Other study ID #: QL1604-002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 20, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: December 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• QL1604
QL1604 3 mg/kg Q3W

Locations

Country	Name	City	State
China	The First Affliated Hospital of Nanchang University	Nanchang
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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