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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05823246
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Qilu Pharmaceutical Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Urothelial Carcinoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: QLF31907

single arm with QLF31907

Interventions

Drug: - QLF31907

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking University Cancer Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Cancer Hospital

Beijing, Beijing, 100142

Site Contact

Lu Si, MD

[email protected]

010-88121122

Fujian Cancer Hospital, Fuzhou, Fujian, China

Status

Not yet recruiting

Address

Fujian Cancer Hospital

Fuzhou, Fujian, 350014

Site Contact

Yu Chen

[email protected]

010-88121122

Changsha, Hunan, China

Status

Not yet recruiting

Address

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011

Site Contact

Haixia Zhang

[email protected]

010-88121122

Jilin Cancer Hospital, Changchun, Jilin, China

Status

Not yet recruiting

Address

Jilin Cancer Hospital

Changchun, Jilin, 130021

Site Contact

Xueying Zhang

[email protected]

010-88121122

The First Hospital of Jilin University, Changchun, Jilin, China

Status

Not yet recruiting

Address

The First Hospital of Jilin University

Changchun, Jilin, 130021

Site Contact

Di Wu

[email protected]

010-88121122

West China Hospital, Chengdu, Sichuan, China

Status

Not yet recruiting

Address

West China Hospital

Chengdu, Sichuan, 610041

Site Contact

Jiyan Liu

[email protected]

010-88121122

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