First-line Non-small-cell Lung Cancer, First-line Urothelial Carcinoma, Second-line Melanoma, Second-line Urothelial Carcinoma
Conditions
Keywords
Evaluate the anti-tumor Efficacy, Safety, Tolerability,Pharmacokinetics and Immunogenicity, A Multi-center, Open-label Phase II Clinical Trial
Brief summary
A Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination with Pembrolizumab in Chinese Patients with Advanced Solid Tumors to evaluate the anti-tumor efficacy, safety, pharmacokinetics and immunogenicity of TJ271 in combination with pembrolizumab in patients with advanced solid tumors.
Detailed description
A Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination with Pembrolizumab in Chinese Patients with Advanced Solid Tumors to evaluate the anti-tumor efficacy, safety, pharmacokinetics and immunogenicity of TJ271 in combination with pembrolizumab in patients with advanced solid tumors.
Interventions
DRUGTJ271 Injection in Combination with Pembrolizumab
TJ271 Injection: 0.9% sodium chloride solution Pembrolizumab: 0.9% sodium chloride solution or 5% glucose solution
Sponsors
TJ Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Volunteer to participate in the clinical study; fully understand and sign the written ICF; willing to follow and able to complete all trial procedures. * Males or females aged =\> 18 years (inclusive) at the time of signing informed consent. * With histologically or cytologically confirmed diagnosis of NSCLC, urothelial carcinoma, or melanoma; * Subjects have at least 1 measurable lesion as defined by RECIST 1.1 (not reside in a field that has been subjected to prior radiotherapy; if within the radiotherapy field, clear evidence of radiographic progression since 14 days after the completion of prior radiotherapy and prior to study enrollment). * Provide at least 5 unstained tissue sections; with tumor expression levels of PD-L1, CD73, and B7-H3 (central laboratory test) assessed by IHC; the enrollment of NSCLC cohort can be based on the PD-L1 TPS detection level tested by the local laboratory (see 10.5.1.2 Tumor Tissue Sample-Related Biomarkers for details). * Expected survival =\> 3 months. * Main organ function is adequate. See details in the protocol Inclusion Criterion. * Female subjects of childbearing potential must have a negative urine pregnancy test or serum pregnancy test within 72 hours prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Male subjects with reproductive potential and female subjects with pregnancy potential (which refer to men or women who have not been surgically sterilized, and women who are not post-menopausal) must use highly effective contraceptive methods such as oral contraceptives, intrauterine devices, sexual abstinence or barrier contraception in conjunction with spermicides during the course of the study and until 6 months after the last dose.
Exclusion criteria
* Diseases amenable to a local curative treatment approach. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | approximately 2 years | To evaluate the anti-tumor efficacy of TJ271 in combination with pembrolizumab in patients with advanced solid tumors, i.e. to evaluate the Objective Response Rate (ORR) as per RECIST 1.1 criteria |
Countries
China
Outcome results
None listed