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Trial Title:
A Study of QLF3108 in Participants With Advanced Solid Tumor
NCT ID:
NCT06019013
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLF3108
Description:
QLF3108 will be administered independent of body weight.
Arm group label:
Dose-Escalation Stage and PK-Expansion Stage
Summary:
This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity
of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108
in patients with advanced solid tumor.
Detailed description:
This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK)
expansion study of QLF3108 in subjects with advanced solid tumor, to determine the
dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a
recommended Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the
safety and tolerability, assess pharmacokinetics parameters and immunogenicity, and
assess the anti-tumor activity of QLF3108 in subjects with advanced solid tumor.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The volunteer has fully given informed consent to the study and voluntarily signed
the informed consent form prior to trial.
2. ≥18 years old and body weight ≥40 kg; Female or male.
3. Histologically or cytologically documented advanced solid tumor;
4. Failed to standard therapy or intolerance, or lack standard therapy advanced solid
tumors.
5. Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1.
6. Life expectancy of at least 12 weeks.
7. Adequate hematologic and end organ function.
8. Female subjects who are not pregnant or not breastfeeding. A negative blood
pregnancy test for females of childbearing potential within 7 days prior to first
dosing.
9. Male and female subjects of childbearing potential must agree to use highly
effective method of contraception during the entire course of the study and within
180 days after the end of the study.
Exclusion Criteria:
1. Patients that have previously received cancer therapy within 4 weeks prior to the
first dose of the investigational drug.
2. Patient has received other investigational drug or other clinical trial treatment
within 4 weeks prior to the first dose of the investigational drug.
3. Active autoimmune disease that has required systemic treatment within 2 years prior
to this study.
4. A live vaccine or live attenuated vaccine was administered within 30 days prior to
the first dose of the investigational drug.
5. Patients with Adverse Events(AEs) from previous treatment that have not recovered to
≤1(CTCAE 5.0）; or are unstable status.
6. Severe concomitant medical condition for bowel obstruction, or implanted colon stent
during screening period.
7. Patients with a history of HIV positive or other immunodeficiency. Or patients with
the history of organ transplant or allogeneic bone marrow (excluding corneal
transplantation).
8. Patients with a history of psychiatric disorders, or epilepsy or dementia, drug or
alcohol abuse, may impact patient completion of the study.
9. Patients may interfere with the interpretation of study results as determined by the
investigator, or are unable to participate in the whole study, or deemed unsuitable
by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese People's Liberation Army (PLA) General Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Jianming, M.D
Phone:
13910866712
Email:
Jianmingxu2014@163.com
Start date:
August 16, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06019013
