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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Urothelial Carcinoma
• Intervention / Treatment: Drug: QLF31907

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lu Si, MD
• Study Contact Backup: Name: Jun Guo, MD; Phone Number: 010-88121122; Email: Guoj307@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital
      • Sub-Investigator: Lu Si, MD
      • Contact: Lu Si, MD; Phone Number: 010-88121122; Email: silu15_silu@126.com
      • Principal Investigator: Jun Guo, MD
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Not yet recruiting
      • Fujian Cancer Hospital
      • Contact: Yu Chen
  • Hunan
    • Changsha, Hunan, China, 410011
      • Not yet recruiting
      • The Second Xiangya Hospital of Central South University
      • Contact: Haixia Zhang
  • Jilin
    • Changchun, Jilin, China, 130021
      • Not yet recruiting
      • the First Hospital of Jilin University
      • Contact: Di Wu
    • Changchun, Jilin, China, 130021
      • Not yet recruiting
      • Jilin Cancer Hospital
      • Contact: Xueying Zhang
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Not yet recruiting
      • West China Hospital
      • Contact: Jiyan Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLF31907; single arm with QLF31907	Drug: QLF31907; Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(part 1)Dose-limiting toxicity(DLT)	28days
(part 2) Objective response rate(ORR)	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
(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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Carcinoma; Melanoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: QLF31907-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No