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

Primary Purpose

Melanoma, Urothelial Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
QLF31907
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 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

Sites / Locations

  • Peking University Cancer HospitalRecruiting
  • Fujian Cancer Hospital
  • The Second Xiangya Hospital of Central South University
  • Jilin Cancer Hospital
  • The First Hospital of Jilin University
  • West China Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QLF31907

Arm Description

single arm with QLF31907

Outcomes

Primary Outcome Measures

(part 1)Dose-limiting toxicity(DLT)
(part 2) Objective response rate(ORR)

Secondary Outcome Measures

(part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)
(part 2) Progression-free survival(PFS)
(part 2) Overall survival(OS)
(part 2) Maximum observed plasma concentration (Cmax)
(part 2) Positive rate of anti-drug antibody(ADA)

Full Information

First Posted
March 10, 2023
Last Updated
May 25, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05823246
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Urothelial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLF31907
Arm Type
Experimental
Arm Description
single arm with QLF31907
Intervention Type
Drug
Intervention Name(s)
QLF31907
Intervention Description
Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1.
Primary Outcome Measure Information:
Title
(part 1)Dose-limiting toxicity(DLT)
Time Frame
28days
Title
(part 2) Objective response rate(ORR)
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
(part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)
Time Frame
up to 2 years
Title
(part 2) Progression-free survival(PFS)
Time Frame
up to 2 years
Title
(part 2) Overall survival(OS)
Time Frame
up to 2 years
Title
(part 2) Maximum observed plasma concentration (Cmax)
Time Frame
up to 2 years
Title
(part 2) Positive rate of anti-drug antibody(ADA)
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Guo, MD
Phone
010-88121122
Email
Guoj307@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Si, MD
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Si, MD
Phone
010-88121122
Email
silu15_silu@126.com
First Name & Middle Initial & Last Name & Degree
Jun Guo, MD
First Name & Middle Initial & Last Name & Degree
Lu Si, MD
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Chen
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haixia Zhang
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueying Zhang
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Di Wu
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyan Liu

12. IPD Sharing Statement

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

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