Health TrialsbyHealthPanel

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

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • JS015

    Biological/Vaccine

    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

    Biological/Vaccine

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

  • Paclitaxel

    Biological/Vaccine

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

  • Irinotecan

    Drug

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

  • Capecitabine

    Drug

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

  • Oxaliplatin

    Drug

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

  • Bevacizumab

    Biological/Vaccine

    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

    Drug

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

  • Leucovorin

    Drug

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

  • Gemcitabine

    Drug

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

  • Albumin-Bound Paclitaxel

    Drug

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

Treatment groups

186 Participants
are divided into 5 treatment groups
Group A: Cohort 1: esophogeal squamous carcinomaExperimental treatment 3 interventions
Group B: Cohort 2: gastric cancerExperimental treatment 2 interventions
Group C: Cohort 3: gastric cancerExperimental treatment 4 interventions
Group D: Cohort 4: colorectal cancerExperimental treatment 7 interventions
Group E: Cohort 5: pancreatic cancerExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

incidence of dose-limiting toxicity （DLT）

incidence and severity of DLT

Time frame
2 Years
2

incidence of adverse event（AE）

adverse events (AE)

Time frame
2 Years
3

Recommended dose for phase II trial RP2D

Recommended dose for phase II trial

Time frame
2 Years

Secondary outcomes

1

Peak concentration (Cmax)

The highest plasma drug concentration that can be achieved after medication

Time frame
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

Time frame
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%

Time frame
2 years
4

immunogenicity

Incidence of Anti-Drug Antibody (ADA)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Junshi Bioscience Co., Ltd.

Lead sponsor

Sponsor GmbH

Collaborator

Source ClinicalTrials.gov
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