Trial Title:
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors
NCT ID:
NCT06139211
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Leucovorin
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Gemcitabine
Capecitabine
Oxaliplatin
Fluorouracil
Irinotecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
JS015
Description:
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.
Arm group label:
Cohort 1: esophogeal squamous carcinoma
Arm group label:
Cohort 2: gastric cancer
Arm group label:
Cohort 3: gastric cancer
Arm group label:
Cohort 4: colorectal cancer
Arm group label:
Cohort 5: pancreatic cancer
Intervention type:
Biological
Intervention name:
Toripalimab
Description:
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
Arm group label:
Cohort 3: gastric cancer
Arm group label:
Cohort 5: pancreatic cancer
Intervention type:
Biological
Intervention name:
Paclitaxel
Description:
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
Arm group label:
Cohort 1: esophogeal squamous carcinoma
Arm group label:
Cohort 2: gastric cancer
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Arm group label:
Cohort 1: esophogeal squamous carcinoma
Arm group label:
Cohort 4: colorectal cancer
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
Arm group label:
Cohort 3: gastric cancer
Arm group label:
Cohort 4: colorectal cancer
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
Arm group label:
Cohort 3: gastric cancer
Arm group label:
Cohort 4: colorectal cancer
Intervention type:
Biological
Intervention name:
Bevacizumab
Description:
Bevacizumab 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.
Arm group label:
Cohort 4: colorectal cancer
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Arm group label:
Cohort 4: colorectal cancer
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Arm group label:
Cohort 4: colorectal cancer
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Arm group label:
Cohort 5: pancreatic cancer
Intervention type:
Drug
Intervention name:
Albumin-Bound Paclitaxel
Description:
Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21
day cycle.
Arm group label:
Cohort 5: pancreatic cancer
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Contact:
Last name:
Jin Li, MD
Phone:
86 021-38804518
Email:
lijin@csco.org.cn
Start date:
November 30, 2023
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
Sponsor GmbH
Agency class:
Other
Source:
Shanghai Junshi Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139211
