Advanced Solid Tumor
Conditions
Brief summary
This is a phase Ib/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics and efficacy.
Interventions
BIOLOGICALJS015
JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
BIOLOGICALToripalimab
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
BIOLOGICALPaclitaxel
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
DRUGIrinotecan
Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
DRUGCapecitabine
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
DRUGOxaliplatin
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
BIOLOGICALBevacizumab
Bevacizumab of 5mg/kg will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or7.5mg/kg on day 1 every 21 day cycle, based on different combined chemotherapy.
DRUGFluorouracil
Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
DRUGLeucovorin
Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
DRUGGemcitabine
Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
DRUGAlbumin-Bound Paclitaxel
Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Sponsors
Sponsor GmbH
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1\. Patients who meet the following criteria for each indication cohort: 1. Esophageal cancer cohort, patients with histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable or with distant metastasis, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy; 2. Gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with locally advanced unresectable or distant metastases, HER2-negative, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy; 3. 1L gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with HER2-negative results and no prior systemic antitumor therapy; 4. Colorectal cancer cohort, patients with histologically confirmed adenocarcinoma of the colon or rectum, who progressed during or after first-line 5-FU-based combination therapy; 5. Pancreatic cancer cohort, patients with histologically or cytologically confirmed locally advanced unresectable or distant metastatic pancreatic ductal adenocarcinoma, who have not received any previous systemic antitumor therapy 2 . Eastern Cooperative Oncology Group (ECOG) 0 or 1; 3. Life expectancy \>=12 weeks; 4. At least one measurable lesion according to RECIST 1.1; 5. Adequate organ function;
Exclusion criteria
1. Leptomeningeal metastases and /or active brain metastases; 2. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.); 3. History of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging; 4. History of immunodeficiency; 5. History of serious cardiovascular and/or cerebrovascular diseases; 6. History of abdominal or tracheo-esophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first dose of administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended dose for phase II trial RP2D | 2 Years | Recommended dose for phase II trial |
| incidence of dose-limiting toxicity （DLT） | 2 Years | incidence and severity of DLT |
| incidence of adverse event（AE） | 2 Years | adverse events (AE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immunogenicity | 2 years | Incidence of Anti-Drug Antibody (ADA) |
| Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) | 2 years | Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR) |
| Peak concentration (Cmax) | 2 years | The highest plasma drug concentration that can be achieved after medication |
| overall survival (OS) | 2 years | The time from first dose to death from any cause |
| Progression free survival (PFS) | 2 years | The time from first dose to Disease progression or death |
| time to peak concentration（Tmax） | 2 years | The time it takes for the drug to reach its maximum concentration (Cmax) in the plasma after administration |
| elimination half life（t1/2） | 2 years | The time it takes for the concentration of the drug in the plasma to be reduced by 50% |
Countries
China
Contacts
Primary ContactJiangnian Liu, PM
Outcome results
None listed