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Advanced Solid TumorPhase 1/2NCT06139211

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

A Phase 1/2 study testing JS015, Toripalimab and Paclitaxel in people with Advanced Solid Tumor, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
JS015, Toripalimab and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
6 Dec 2023to 28 May 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients who meet the following criteria for each indication cohort:
  • 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;
  • 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;
  • 1L gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with HER2-negative results and no prior systemic antitumor therapy;
  • 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;
  • 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;

Who cannot join

  • Leptomeningeal metastases and /or active brain metastases;
  • Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.);
  • History of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging;
  • History of immunodeficiency;
  • History of serious cardiovascular and/or cerebrovascular diseases;
  • History of abdominal or tracheo-esophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first dose of administration

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

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

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS015Biological

    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.

  • ToripalimabBiological

    Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.

  • PaclitaxelBiological

    Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.

  • IrinotecanDrug

    Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.

  • CapecitabineDrug

    Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.

  • OxaliplatinDrug

    Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.

  • BevacizumabBiological

    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.

  • FluorouracilDrug

    Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.

  • LeucovorinDrug

    Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.

  • GemcitabineDrug

    Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

  • Albumin-Bound PaclitaxelDrug

    Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

Study groups in NCT06139211
Study groupRoleWhat they receive
Cohort 1: esophogeal squamous carcinomaExperimentalIn Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan
Receives: Biological: JS015; Biological: Paclitaxel; Drug: Irinotecan
Cohort 2: gastric cancerExperimentalIn Cohort 2, patients will be treated with JS015 in combination with paclitaxel
Receives: Biological: JS015; Biological: Paclitaxel
Cohort 3: gastric cancerExperimentalIn Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX
Receives: Biological: JS015; Biological: Toripalimab; Drug: Capecitabine; Drug: Oxaliplatin
Cohort 4: colorectal cancerExperimentalIn Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI
Receives: Biological: JS015; Drug: Irinotecan; Drug: Capecitabine; Drug: Oxaliplatin; Biological: Bevacizumab; Drug: Fluorouracil; Drug: Leucovorin
Cohort 5: pancreatic cancerExperimentalIn Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine
Receives: Biological: JS015; Biological: Toripalimab; Drug: Gemcitabine; Drug: Albumin-Bound Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of dose-limiting toxicity （DLT）

    incidence and severity of DLT

    Measured: 2 Years

  2. incidence of adverse event（AE）

    adverse events (AE)

    Measured: 2 Years

  3. Recommended dose for phase II trial RP2D

    Recommended dose for phase II trial

    Measured: 2 Years

Secondary outcomes (7)

  1. Peak concentration (Cmax)

    The highest plasma drug concentration that can be achieved after medication

    Measured: 2 years

  2. time to peak concentration（Tmax）

    The time it takes for the drug to reach its maximum concentration (Cmax) in the plasma after administration

    Measured: 2 years

  3. elimination half life（t1/2）

    The time it takes for the concentration of the drug in the plasma to be reduced by 50%

    Measured: 2 years

  4. immunogenicity

    Incidence of Anti-Drug Antibody (ADA)

    Measured: 2 years

  5. 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)

    Measured: 2 years

  6. Progression free survival (PFS)

    The time from first dose to Disease progression or death

    Measured: 2 years

  7. overall survival (OS)

    The time from first dose to death from any cause

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start6 Dec 2023
  3. Primary completion28 May 2026
  4. Study completion28 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139211
Sponsor's protocol ID
JS015-002-Ib/II-GI
Status last verified
Aug 2026
First submitted
14 Nov 2023
Last updated
12 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JS015, Toripalimab and Paclitaxel in people with Advanced Solid Tumor, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of dose-limiting toxicity （DLT） (time frame: 2 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06139211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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