A Phase II Study to Evaluate the Efficacy and Safety of QLF31907 Injection in Patients With Advanced Melanoma and Urothelial Carcinoma

Qilu Pharmaceutical Co., Ltd.6 sites in 1 country66 target enrollmentApril 24, 2023

ConditionsMelanoma Urothelial Carcinoma

InterventionsQLF31907

DrugsQLF31907

Overview

Phase: Phase 2
Intervention: QLF31907
Conditions: Melanoma
Sponsor: Qilu Pharmaceutical Co., Ltd.
Enrollment: 66
Locations: 6
Primary Endpoint: (part 1)Dose-limiting toxicity(DLT)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 24, 2023

End Date

July 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Qilu Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

QLF31907

single arm with QLF31907

Intervention: QLF31907

Outcomes

Primary Outcomes

(part 1)Dose-limiting toxicity(DLT)

Time Frame: 28days

(part 2) Objective response rate(ORR)

Time Frame: up to 2 years

Secondary Outcomes

(part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)(up to 2 years)
(part 2) Overall survival(OS)(up to 2 years)
(part 2) Progression-free survival(PFS)(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)