A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS015 Combination Therapy in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06139211
• Other study ID #: JS015-002-Ib/II-GI
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 30, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: November 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: Jiangnian Liu, PM
• Phone: +86 18733176288
• Email: jiangnian_liu[@]junshipharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 186
• Est. completion date: April 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Biological:
• 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.

Drug:
• 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.

Biological:
• Bevacizumab
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.

Drug:
• 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.

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.	Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of dose-limiting toxicity (DLT)	incidence and severity of DLT	2 Years
Primary	incidence of adverse event(AE)	adverse events (AE)	2 Years
Primary	Recommended dose for phase II trial RP2D	Recommended dose for phase II trial	2 Years
Secondary	Peak concentration (Cmax)	The highest plasma drug concentration that can be achieved after medication	2 years
Secondary	time to peak concentration(Tmax)	The time it takes for the drug to reach its maximum concentration (Cmax) in the plasma after administration	2 years
Secondary	elimination half life(t1/2)	The time it takes for the concentration of the drug in the plasma to be reduced by 50%	2 years
Secondary	immunogenicity	Incidence of Anti-Drug Antibody (ADA)	2 years
Secondary	Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)	Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)	2 years
Secondary	Progression free survival (PFS)	The time from first dose to Disease progression or death	2 years
Secondary	overall survival (OS)	The time from first dose to death from any cause	2 years