Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma

NCT ID: NCT05823246

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2024-07-31

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.

Conditions

Melanoma; Urothelial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLF31907

single arm with QLF31907

Group Type: EXPERIMENTAL

QLF31907

Intervention Type: DRUG

Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1.

Interventions

QLF31907

Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status: NOT_YET_RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: NOT_YET_RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, China

Site Status: NOT_YET_RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status: NOT_YET_RECRUITING

West China Hospital

Chengdu, Sichuan, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Jun Guo, MD

Role: CONTACT

Guoj307@126.com

010-88121122

Lu Si, MD

Role: CONTACT

Facility Contacts

Lu Si, MD

Role: primary

silu15_silu@126.com

010-88121122

Yu Chen

Role: primary

Haixia Zhang

Role: primary

Xueying Zhang

Role: primary

Di Wu

Role: primary

Jiyan Liu

Role: primary

Other Identifiers

QLF31907-201

Identifier Type: -

Identifier Source: org_study_id