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

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05823246
Collaborator
(none)
66
Enrollment
6
Locations
1
Arm
14.6
Anticipated Duration (Months)
11
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study to Evaluate the Efficacy and Safety of QLF31907 Injection in Patients With Advanced Melanoma and Urothelial Carcinoma
Anticipated Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. (part 1)Dose-limiting toxicity(DLT) [28days]

  2. (part 2) Objective response rate(ORR) [up to 2 years]

Secondary Outcome Measures

  1. (part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE) [up to 2 years]

  2. (part 2) Progression-free survival(PFS) [up to 2 years]

  3. (part 2) Overall survival(OS) [up to 2 years]

  4. (part 2) Maximum observed plasma concentration (Cmax) [up to 2 years]

  5. (part 2) Positive rate of anti-drug antibody(ADA) [up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Cancer Hospital Beijing Beijing China 100142
2 Fujian Cancer Hospital Fuzhou Fujian China 350014
3 The Second Xiangya Hospital of Central South University Changsha Hunan China 410011
4 Jilin Cancer Hospital Changchun Jilin China 130021
5 The First Hospital of Jilin University Changchun Jilin China 130021
6 West China Hospital Chengdu Sichuan China 610041

Sponsors and Collaborators

  • Qilu Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05823246
Other Study ID Numbers:
  • QLF31907-201
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Melanoma
Carcinoma, Transitional Cell

Study Results

No Results Posted as of Apr 21, 2023