Clinical trial NCT05823246: Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma
Official title: A Phase II Study to Evaluate the Efficacy and Safety of QLF31907 Injection in Patients With Advanced Melanoma and Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Urothelial Carcinoma
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: (part 1)Dose-limiting toxicity(DLT)
timeFrame: 28days
measure: (part 2) Objective response rate(ORR)
timeFrame: up to 2 years
Secondary outcomes:
measure: (part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)
timeFrame: up to 2 years
measure: (part 2) Progression-free survival(PFS)
timeFrame: up to 2 years
measure: (part 2) Overall survival(OS)
timeFrame: up to 2 years
measure: (part 2) Maximum observed plasma concentration (Cmax)
timeFrame: up to 2 years
measure: (part 2) Positive rate of anti-drug antibody(ADA)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References: