A Phase 1 Study to Evaluate JS019 in Advanced Solid Tumors or Lymphomas

NCT05374226 | Unknown Phase 1

• 1 other identifier: JS019-001-I
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JS019 as monotherapy in patients with advanced malignant solid tumors/lymphomas. The study includes JS019 monotherapy dose escalation, dose expansion and indication expansion stages to investigate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of JS019 as monotherapy.

Conditions

Advanced Solid Tumors or Lymphomas

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability

  Incidence of DLT, incidence and severity of adverse events (AEs) and serious adverse events (SAEs), clinically significant abnormal changes in laboratory tests and other tests

  2 years

• Maximum tolerated dose (MTD, if possible) and the recommended phase 2 dose (RP2D)

  Maximum tolerated dose (MTD) : The highest dose at which \<1/3 patients experience DLT events. Phase II recommended dose: safety, pharmacokinetics, and preliminary efficacy data of dose escalation will be integrated. When the Maximum tolerated dose(MTD) is determined, the Maximum tolerated dose(MTD) is usually used as the Phase II recommended dose(RP2D), or the dose lower than the Maximum tolerated dose(MTD) is selected as the Phase II recommended dose(RP2D) based on the comprehensive data.

  2 years

Secondary Outcomes (9)

• Pharmacokinetics (PK)

  2 years

• Immunogenicity

  2 years

• Pharmacodynamics （PD）

  2 years

• Objective response rate (ORR)

  2 years

• Duration of response (DOR)

  2 years

Other Outcomes (1)

• Biomarkers

  2 years

Study Arms (4)

JS019 0.3 mg/kg

EXPERIMENTAL

repeat dose every 21 days up

Biological: JS019

JS019 1 mg/kg

EXPERIMENTAL

repeat dose every 21 days up

Biological: JS019

JS019 3 mg/kg

EXPERIMENTAL

repeat dose every 21 days up

Biological: JS019

JS019 10 mg/kg

EXPERIMENTAL

repeat dose every 21 days up

Biological: JS019

Interventions

JS019 BIOLOGICAL

Four dose levels are preset: 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg. The subjects are treated with JS019 by intravenous infusion, once every 3 weeks (Q3W). A treatment cycle is 21 days, and the DLT observation period is 21 days after the first administration.

JS019 0.3 mg/kg; JS019 1 mg/kg; JS019 10 mg/kg; JS019 3 mg/kg

Eligibility Criteria

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

You may qualify if:

• Be able to understand and willing to sign the Informed Consent Form;
• Male or female aged 18\~75 years (included);
• Patients with pathologically confirmed advanced malignant solid tumors or lymphomas;
• Failed or unsuitable for standard treatment, received at least one line of systemic treatment;
• Eastern Cooperative Oncology Group (ECOG) physical fitness score: 0\~1;
• Expected survival period ≥ 12 weeks;
• At least one measurable lesion according to criteria RECIST v1.1 or Lugano 2014;

You may not qualify if:

• Patients with known hypersensitivity to the components of JS019;
• Patients who have received the treatment with anti-CD39 antibodies or inhibitors;
• Patients who participated in other clinical studies within 4 weeks prior to the first administration of JS019, except patients are in the follow-up period of observational (non-interventional) clinical study or interventional study;
• Patients who have received major surgery within 4 weeks before the first dose or expected to undergo major surgery during the study (as judged by the investigator) or are in the recovery period from surgery;
• Patients who have received anti-tumor therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biological therapy, within 4 weeks or 5 half-lives of the therapy (whichever is shorter) prior to the first dose of JS019. Patients who have received traditional Chinese medicine or Chinese patent medicine preparations with anti-tumor indications within 2 weeks before the first dose of JS019. Can accept hormone therapy for non-tumor-related diseases (such as insulin therapy for diabetes and hormone replacement therapy, etc.);
• Patients who have discontinued immunotherapy due to immune-related AEs.
• Patients who have used immunosuppressive drugs within 4 weeks prior to the first dose of JS019, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids ≤10 mg/day prednisone or equivalent.

Sponsors & Collaborators

• Suzhou Kebo Ruijun Biotechnology Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

lin shen, Doctor of medicine

CONTACT

8610-88196561; linshenpku@163.com

Study Design

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

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 16, 2022
• Study Start: March 31, 2022
• Primary Completion: December 11, 2023
• Study Completion: March 7, 2024
• Last Updated: May 16, 2022

Record last verified: 2022-04

Locations

CN (1)