Advanced Solid Tumor
Conditions
Brief summary
In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.
Interventions
DRUGQL1604
QL1604 3 mg/kg Q3W
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed