Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma
A Phase II Study to Evaluate the Efficacy and Safety of QLF31907 Injection in Patients With Advanced Melanoma and Urothelial Carcinoma
1 other identifier
interventional
66
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2023
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedStudy Start
First participant enrolled
April 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedMay 26, 2023
April 1, 2023
5 months
March 10, 2023
May 25, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
(part 1)Dose-limiting toxicity(DLT)
28days
(part 2) Objective response rate(ORR)
up to 2 years
Secondary Outcomes (5)
(part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)
up to 2 years
(part 2) Progression-free survival(PFS)
up to 2 years
(part 2) Overall survival(OS)
up to 2 years
(part 2) Maximum observed plasma concentration (Cmax)
up to 2 years
(part 2) Positive rate of anti-drug antibody(ADA)
up to 2 years
Study Arms (1)
QLF31907
EXPERIMENTALsingle arm with QLF31907
Interventions
Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1.
Eligibility Criteria
You may qualify if:
- Subjects voluntarily participated and signed a written informed consent form
- Age ≥ 18 years, male or female
- ECOG performance status of 0 or 1
- Expected life-expectancy ≥ 3 months
- Histologically confirmed diagnosis of locally advanced or metastatic unresectable melanoma or urothelial carcinoma, failed or intolerant or rejected to standard therapy
- Patients must have at least one measurable lesion according to RECIST v1.1
- Adequate organ function prior to QLF31907 administration
- 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.
You may not qualify if:
- Prior treatment with 4-1BB agonist or 4-1BB recombinant fusion protein
- Known to be allergic to any excipients of QLF31907 or a history of severe allergic reactions to other monoclonal antibodies
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or autologous stem cell transplantation within 180 days
- Known history of cytotherapy or antitumor vaccine or other antitumor therapy or surgical treatment of main organs within 4 weeks
- Known history of systemic glucocorticoid therapy or other immunosuppressants within 14 days
- Active central nervous system (CNS) metastases
- Known history of other active malignant tumor within 3 years, unless completely cured
- With uncontrolled or clinically symptomatic pleural, pericardial or abdominal effusions
- An active infectious disease requiring intravenous antibiotic therapy
- Failure to recover to grade 1 from adverse reactions due to prior treatment according to CTCAE v5.0
- An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior immunotherapy
- 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
- Poorly controlled respiratory, circulatory or endocrine diseases
- Known history of drugs abuse, alcoholism, neurologic or psychiatric disorders
- Patients who are breastfeeding
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
West China Hospital
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Lu Si, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2023
First Posted
April 21, 2023
Study Start
April 24, 2023
Primary Completion
October 1, 2023
Study Completion
July 1, 2024
Last Updated
May 26, 2023
Record last verified: 2023-04