A Phase I Study Of JS015 in Patients With Advanced Solid Tumors

NCT05770310 | Unknown Phase 1

• 1 other identifier: JS015-001-I
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of JS015 in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） was determined based on the safety, pharmacokinetics, and initial efficacy data of the dose escalation and extension.

Conditions

Advanced Solid Cancer

Outcome Measures

Primary Outcomes (2)

• dose-limiting toxicity （DLT）、adverse event（AE）、serious adverse event（SAE）

  incidence and severity of DLT, adverse events (AE), serious adverse events (SAE), Abnormal changes in laboratory and other tests with clinical significance

  2Years

• Maximum tolerated dose (MTD),RP2D

  Maximum tolerated dose (MTD), Recommended dose for phase II trial

  2 Years

Secondary Outcomes (6)

• Peak concentration（Cmax）

  2 years

• time to peak（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

Study Arms (1)

JS015

EXPERIMENTAL

Drug: JS015

Interventions

JS015 DRUG

Patient receives specific dose of JS015. The administration method of JS015 is intravenous infusion.

JS015

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate in this study and provide written informed consent;
• Histologically- or cytologically-confirmed advanced solid tumors considered failure to the standard treatment, or with no standard treatment, or not available to standard treatment;
• At least one measurable lesion according to RECIST 1.1;
• Life expectancy ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) 0 or 1;
• Adequate organ function;
• Treatment related toxicities due to prior anti-cancer therapy including surgery and radiotherapy must be ≤ grade 1;
• Women of childbearing age must confirm that the serum pregnancy test is negative within 7 days before the first dose; Male and female patients of child bearing potential will to use abstinence or an effective method of contraception throughout the treatment period and for 90 days following the last dose of study drug;

You may not qualify if:

• Allergy or contraindication to JS015 and its ingredients;
• Has a known additional malignancy in the last 5 years.
• Pregnancy or lactation;
• History of immunodeficiency, including human immunodeficiency virus(HIV) test positive, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Brain or meningeal metastases
• Pleural effusion, peritoneal effusion or pericardial effusion that required treatment (such as puncture, drainage)
• Severe cardiovascular and cerebrovascular diseases;
• Previous antineoplastic therapy meets washout requirements.
• Severe infection (Criteria for the evaluation of common adverse events(CTC AE) 5.0\>2 grade) occurred within 28 days before the first study administration; Active infection or unexplained fever \> 38.5°C ;
• Has active tuberculosis or hepatitis B (HBV) or hepatitis C (HCV);
• moderate to severe that seriously affect lung function;
• Other serious physical or mental diseases or laboratory abnormalities, or alcoholism, drug abuse, etc.,

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (4)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Study Officials

• Jin Li, Medical Doctor

  Affiliation: Shanghai Oriental Hospital

  PRINCIPAL INVESTIGATOR

• Jinming Yu, Medical Doctor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Xu, Project manager

CONTACT

+86 13761020175; kai_xu@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 15, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)