A Phase I Study of QL1604 for Advanced Solid Tumors

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: QL1604

• Registration Number: NCT05801094
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-20
• Status Verified: 2023-03
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-04-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QL1604	QL1604	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

The First Affliated Hospital of Nanchang University; 🇨🇳 Nanchang, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China