A Phase I Study of QL1604 for Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2023-12-15

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QL1604

Group Type EXPERIMENTAL

QL1604

Intervention Type DRUG

QL1604 3 mg/kg Q3W

Interventions

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QL1604

QL1604 3 mg/kg Q3W

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No