A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors
NCT ID: NCT06139211
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
186 participants
INTERVENTIONAL
2024-01-03
2026-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: esophogeal squamous carcinoma
In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan
JS015
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.
Paclitaxel
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
Irinotecan
Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Cohort 2: gastric cancer
In Cohort 2, patients will be treated with JS015 in combination with paclitaxel
JS015
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.
Paclitaxel
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
Cohort 3: gastric cancer
In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX
JS015
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.
Toripalimab
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
Capecitabine
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
Oxaliplatin
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
Cohort 4: colorectal cancer
In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI
JS015
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.
Irinotecan
Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Capecitabine
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
Oxaliplatin
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
Bevacizumab
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.
Fluorouracil
Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Leucovorin
Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Cohort 5: pancreatic cancer
In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine
JS015
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.
Toripalimab
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
Gemcitabine
Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Albumin-Bound Paclitaxel
Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Interventions
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JS015
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.
Toripalimab
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
Paclitaxel
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
Irinotecan
Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Capecitabine
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
Oxaliplatin
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
Bevacizumab
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.
Fluorouracil
Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Leucovorin
Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Gemcitabine
Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Albumin-Bound Paclitaxel
Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Sponsor GmbH
OTHER
Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jin Li, MD
Role: primary
Other Identifiers
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JS015-002-Ib/II-GI
Identifier Type: -
Identifier Source: org_study_id