Trial Title:
Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma
NCT ID:
NCT05823246
Condition:
Melanoma
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Melanoma
Carcinoma, Transitional Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLF31907
Description:
Intravenous infusion once every two weeks. The dose administered in part 2 will depend on
the outcome of part 1.
Arm group label:
QLF31907
Summary:
This study will assess the safety, tolerability and efficacy of every-2-week dosing of
QLF31907 injection in patients with advanced melanoma and urothelial carcinoma.
Detailed description:
This study is divided into two parts. The first part is the safety and tolerability
observation period, mainly observing the safety and tolerability of QLF31907. The second
part is mainly the efficacy observation period, further evaluating the efficacy and
safety of QLF31907 in patients with advanced melanoma and urothelial carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects voluntarily participated and signed a written informed consent form
2. Age ≥ 18 years, male or female
3. ECOG performance status of 0 or 1
4. Expected life-expectancy ≥ 3 months
5. Histologically confirmed diagnosis of locally advanced or metastatic unresectable
melanoma or urothelial carcinoma, failed or intolerant or rejected to standard
therapy
6. Patients must have at least one measurable lesion according to RECIST v1.1
7. Adequate organ function prior to QLF31907 administration
8. All subjects of reproductive potential must agree to use an effective method of
contraception during the study and for 180 days after the last dose, and women of
reproductive age must have a negative blood pregnancy result within 7 days prior to
the first dose.
Exclusion Criteria:
1. Prior treatment with 4-1BB agonist or 4-1BB recombinant fusion protein
2. Known to be allergic to any excipients of QLF31907 or a history of severe allergic
reactions to other monoclonal antibodies
3. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation, or autologous stem cell transplantation within 180 days
4. Known history of cytotherapy or antitumor vaccine or other antitumor therapy or
surgical treatment of main organs within 4 weeks
5. Known history of systemic glucocorticoid therapy or other immunosuppressants within
14 days
6. Active central nervous system (CNS) metastases
7. Known history of other active malignant tumor within 3 years, unless completely
cured
8. With uncontrolled or clinically symptomatic pleural, pericardial or abdominal
effusions
9. An active infectious disease requiring intravenous antibiotic therapy
10. Failure to recover to grade 1 from adverse reactions due to prior treatment
according to CTCAE v5.0
11. An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior
immunotherapy
12. Known history of active hepatitis B/C infection, severe cardiovascular and
cerebrovascular disease, idiopathic pulmonary fibrosis, pneumoconiosis, asbestosis,
hepatitis (nonalcoholic steatohepatitis, alcoholic or autoimmune hepatitis),
cirrhosis, active tuberculosis, active syphilis, HIV infection
13. Poorly controlled respiratory, circulatory or endocrine diseases
14. Known history of drugs abuse, alcoholism, neurologic or psychiatric disorders
15. Patients who are breastfeeding
16. Other serious physical or psychiatric illnesses or laboratory abnormalities that may
increase the risk of participating in the study, or interfere with the results of
the study, and patients who are not suitable for participation in this study in the
opinion of the investigator
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu Si, MD
Phone:
010-88121122
Email:
silu15_silu@126.com
Investigator:
Last name:
Jun Guo, MD
Email:
Principal Investigator
Investigator:
Last name:
Lu Si, MD
Email:
Sub-Investigator
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yu Chen
Facility:
Name:
The Second Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410011
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Haixia Zhang
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xueying Zhang
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Di Wu
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jiyan Liu
Start date:
April 24, 2023
Completion date:
July 2024
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/NCT05823246
