NCT06139211

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 3, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

November 14, 2023

Last Update Submit

December 17, 2024

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

  • incidence of dose-limiting toxicity （DLT）

    incidence and severity of DLT

    2 Years

  • incidence of adverse event（AE）

    adverse events (AE)

    2 Years

  • Recommended dose for phase II trial RP2D

    Recommended dose for phase II trial

    2 Years

Secondary Outcomes (7)

  • Peak concentration (Cmax)

    2 years

  • time to peak concentration（Tmax）

    2 years

  • elimination half life（t1/2）

    2 years

  • immunogenicity

    2 years

  • Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)

    2 years

  • +2 more secondary outcomes

Study Arms (5)

Cohort 1: esophogeal squamous carcinoma

EXPERIMENTAL

In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan

Biological: JS015Biological: PaclitaxelDrug: Irinotecan

Cohort 2: gastric cancer

EXPERIMENTAL

In Cohort 2, patients will be treated with JS015 in combination with paclitaxel

Biological: JS015Biological: Paclitaxel

Cohort 3: gastric cancer

EXPERIMENTAL

In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX

Biological: JS015Biological: ToripalimabDrug: CapecitabineDrug: Oxaliplatin

Cohort 4: colorectal cancer

EXPERIMENTAL

In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI

Biological: JS015Drug: IrinotecanDrug: CapecitabineDrug: OxaliplatinBiological: BevacizumabDrug: FluorouracilDrug: Leucovorin

Cohort 5: pancreatic cancer

EXPERIMENTAL

In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine

Biological: JS015Biological: ToripalimabDrug: GemcitabineDrug: Albumin-Bound Paclitaxel

Interventions

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.

Cohort 1: esophogeal squamous carcinomaCohort 2: gastric cancerCohort 3: gastric cancerCohort 4: colorectal cancerCohort 5: pancreatic cancer
ToripalimabBIOLOGICAL

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

Cohort 3: gastric cancerCohort 5: pancreatic cancer
PaclitaxelBIOLOGICAL

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

Cohort 1: esophogeal squamous carcinomaCohort 2: gastric cancer
IrinotecanDRUG

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

Cohort 1: esophogeal squamous carcinomaCohort 4: colorectal cancer
CapecitabineDRUG

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

Cohort 3: gastric cancerCohort 4: colorectal cancer
OxaliplatinDRUG

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

Cohort 3: gastric cancerCohort 4: colorectal cancer
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.

Cohort 4: colorectal cancer
FluorouracilDRUG

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

Cohort 4: colorectal cancer
LeucovorinDRUG

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

Cohort 4: colorectal cancer
GemcitabineDRUG

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

Cohort 5: pancreatic cancer
Albumin-Bound PaclitaxelDRUG

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

Cohort 5: pancreatic cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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;
  • L 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Interventions

toripalimabPaclitaxelIrinotecanCapecitabineOxaliplatinBevacizumabFluorouracilLeucovorinGemcitabineAlbumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesAlbumins

Central Study Contacts

Jiangnian Liu, PM

CONTACT

+86 18733176288jiangnian_liu@junshipharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

January 3, 2024

Primary Completion

November 1, 2025

Study Completion

January 28, 2026

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)