Advanced Malignant Tumor
Conditions
Brief summary
This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of QLS31901 in advanced or metastatic malignancies
Detailed description
Study Design: This open label, multicenter, first in human study consists of 2 parts. Part 1 is a dose escalation to find the recommended dose for the expansion. Part 2 is a dose expansion to confirm the dose of QLS31901 through further evaluation of safety, tolerability, Pk, preliminary antitumor activity, and functional target engagement. The study includes three periods: Screening( up to 28 days prior to the first dose of study drug); Treatment(first dose of study drug with treatment cycles of 28 days); and Follow-up ( 30days 、60days and 90 days after the last dose) including survival follow-up checks every 3 months up to 12 months after the death of patient or the end of this clinical trial .
Interventions
DRUGQLS31901
QLS31901 is a bispecific antibody specifically targeting PD-L1 and TGF-β.In part 1,the QLS31901 will be administered in sequential cohorts on day 1 of every 21-day cycle (3 weeks) via IV infusion.In part 2,the QLS31901 will be administered in parallel cohorts(selected dose and dosing frequency ) on day 1 of every 2week or every 3week via IV infusion
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
1. Age: 18 to 75 years, male or female. 2. Eastern Cooperative Oncology Group (ECOG) score of 0-1. 3. Life expectancy ≥ 12 weeks. 4. At least one measurable lesion by imaging according to RECIST v1.1 evaluation criteria 5. Patients who failed standard treatment or were absent of standard treatment and have a pathologically confirmed advanced malignant tumor. 6. Sufficient organ function before the first dose of the investigational product
Exclusion criteria
1. Prior anti-cancer immunotherapy(Those who have received PD1 / PDL1 can be included in this study). 2. Known allergy to the investigational product or any excipient or severe anaphylaxis to other monoclonal antibodies. 3. Received any of the following treatments or drugs prior to the first dose of the study: 4. Symptomatic CNS metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis before signing of the informed consent form. 5. Patients with uncontrollable severe exudation (thoracic cavity, pericardium, abdominal cavity); 6. Presence of active autoimmune disease or has a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \[patients whose condition can be controlled by thyroid hormone replacement therapy can be enrolled\]; Subjects suffer from skin diseases that does not require systemic treatment, such as vitiligo, psoriasis, alopecia, type I diabetes, or childhood asthma that has completely alleviated and does not require any adult intervention can be enrolled. Asthmatic patients requiring bronchodilators for medical intervention cannot be enrolled);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | 21days | Safety and tolerability,as defined by the rate of treatment-related events as assessed by NCI CTCAE v5.0. |
Countries
China
Contacts
Primary Contactoliver Kong, CMO
Outcome results
None listed