Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Antibodies

Docetaxel

Antibodies, Bispecific

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Topoisomerase I Inhibitors

Enzyme Inhibitors

intravenous administration, once every 3 weeks

QLF31907

intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks

intravenous administration, 75mg/m2, d1, every 3 weeks

Lin Shen

This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.

A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors

A Phase 1b/2 Trial to Evaluate the Efficacy and Safety of QLF31907 (PD-L1/4-1BB Bi-specific Antibody) Combination Therapy in Patients With Advanced Malignant Tumors

The DLT of QLF31907 combination therapy will be determined

the ORR of QLF31907 combinaton therapy will be determined

to evaluate the severity, incidence and causality of adverse events (AEs)

the area under the concentration-time curve (AUC) of QLF31907 will be determined

the anti-drug antibody(ADA) against QLF31907 will be determined

the OS of QLF31907 combination therapy will be determined

the maximum plasma concentration (Cmax) of QLF31907 will be determined

Qilu Pharmaceutical Co., Ltd.

Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Transitional Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

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

Jun Guo, MD

Lu Si, MD

Yu Chen

Haixia Zhang

Xueying Zhang

Di Wu

Jiyan Liu

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.

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.

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

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

In this study, seven dose groups were proposed. The frequency of administration was once every two weeks, and four weeks was one therapeutic cycle. The subjects will receive six cycles of QLF31907 treatment at most.

Bin Liu

Tongyu Lin

This study is designed to evaluate the safety and tolerability of QLF31907 injection, to identify the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), and determine the recommended phase Ib dose(RPIbD) and recommended phase II dose (RP2D)in patients with advanced malignant tumors.

A Phase Ia Clinical Study of QLF31907 Injection in Patients With Advanced Malignant Tumors

An Open, Dose-escalating Phase Ia Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of QLF31907 Injection in Patients With Advanced Cancer

Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Peak Plasma Concentration (Cmax) of QLF31907 will be determined.

Area under the plasma concentration versus time curve (AUC) of QLF31907 will be determined.

Time to Cmax (Tmax) of QLF31907 will be determined.

Frequency of anti-drug antibodies (ADA) against QLF31907 will be determined.

Solid tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1), and lymphoma response will be determined by criteria of lugano 2014.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors	NCT06394713	Advanced Malign...	QLF31907 Irinotecan Docetaxel	18 Years -	Qilu Pharmaceutical Co., Ltd.
Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma	NCT05823246	Melanoma Urothelial Carc...	QLF31907	18 Years -	Qilu Pharmaceutical Co., Ltd.
A Phase Ia Clinical Study of QLF31907 Injection in Patients With Advanced Malignant Tumors	NCT05150405	Solid Tumor Lymphoma, Non-H...	QLF31907	18 Years -	Qilu Pharmaceutical Co., Ltd.
Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma	NCT05823246	Melanoma Urothelial Carc...	QLF31907	18 Years -	Qilu Pharmaceutical Co., Ltd.
A Phase Ia Clinical Study of QLF31907 Injection in Patients With Advanced Malignant Tumors	NCT05150405	Solid Tumor Lymphoma, Non-H...	QLF31907	18 Years -	Qilu Pharmaceutical Co., Ltd.
Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma	NCT05823246	Melanoma Urothelial Carc...	QLF31907	18 Years -	Qilu Pharmaceutical Co., Ltd.
A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors	NCT06394713	Advanced Malign...	QLF31907 Irinotecan Docetaxel	18 Years -	Qilu Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for qlf31907

Every month we try and update this database with for qlf31907 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for qlf31907

Every month we try and update this database with for qlf31907 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for qlf31907 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.