Advanced Malignant Solid Tumors
Conditions
Brief summary
This is a multicenter, open-label Phase II clinical study. The primary objective is to evaluate the investigator-assessed objective response rate of JS212 and JS213 as monotherapy and in combination regimens in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and preliminary efficacy of JS212, JS213, as well as JS212 in combination with JS213, toripalimab, and JS207.
Detailed description
This study is a Phase II clinical trial designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of JS212 and JS213 as monotherapy and in combination therapy in patients with advanced malignant solid tumors. This study plans to conduct 5 treatment cohorts: Cohort 1: JS212 Cohort 2: JS213 Cohort 3: JS212 + JS213 Cohort 4: JS212 + JS207 Cohort 5: JS212 + Toripalimab
Interventions
administered by intravenous infusion on Day 1 of each 21-day cycle.
administered by intravenous infusion on Day 1 of each 21-day cycle.
administered by intravenous infusion on Day 1 of each 21-day cycle.
DRUGToripalimab
administered by intravenous infusion on Day 1 of each 21-day cycle.
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 75 years, male or female. 2. Histologically confirmed metastatic or unresectable clear cell renal cell carcinoma (RCC); histologically or cytologically confirmed metastatic or unresectable castration-resistant prostate cancer (CRPC); histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC); histologically confirmed unresectable Stage III or IV melanoma. 3. For RCC: disease progression following prior anti-angiogenic targeted therapy and PD-(L)1 inhibitor therapy; for CRPC: disease progression following prior abiraterone or novel androgen receptor (AR) inhibitor therapy; for UC: disease progression following prior PD-(L)1 inhibitor and platinum-based chemotherapy or PD-(L)1 inhibitor and ADC drugs; for melanoma: disease progression following prior chemotherapy and/or PD-(L)1 inhibitor therapy. 4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6. Life expectancy ≥ 12 weeks. 7. Adequate organ function. 8. Male and female subjects of reproductive potential must agree to use highly effective contraception during the study and avoid conception; women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and must not be breastfeeding. 9. CRPC subjects must be on continuous luteinizing hormone-releasing hormone agonist (LHRHa) therapy or have undergone bilateral orchiectomy; subjects without bilateral orchiectomy must plan to maintain effective LHRHa therapy throughout the study; castrate levels of testosterone at screening; metastatic disease confirmed by CT/MRI or radionuclide bone scan. 10. Subjects voluntarily participate in the study and have signed the informed consent form.
Exclusion criteria
1. Major surgery, radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy, or other investigational agents administered prior to the first study dose. 2. Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 6 years | Objective response rate(ORR), assessed by investigator ( per RECIST v1.1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to 6 years | Progression-free survival (PFS), assessed by investigators (per RECIST v1.1) |
| DoR | up to 6 years | Duration of response (DoR), assessed by investigators |
| DCR | up to 6 years | Disease control rate (DCR), assessed by investigators |
| OS | up to 6 years | overall survival (OS) |
| Safety (AE) | up to 6 years | Incidence and severity of adverse events (AEs) |
| Number of Participants With Abnormal Laboratory Values or clinical findings | up to 6 years | Abnormal laboratory or clinical findings |
| dose-limiting toxicity（DLT） | up to 6 years | Incidence and severity of dose-limiting toxicity（DLT） |
Countries
China
Contacts
CONTACTYuteng Shen, Project manager
Outcome results
None listed