A Clinical Study to Evaluate the Safety, Tolerability,JS019 in Patients With Advanced Solid Tumors

NCT05508373 | Unknown Phase 1

• 1 other identifier: JS019-002-I
• Study Type: interventional
• Target: 72
• 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 The study includes JS019 monotherapy dose escalation, dose expansion stages to investigate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of JS019 as monotherapy.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Safety Incidence of DLT severity of adverse events (AEs) and serious adverse events (SAEs)and tolerability

  Incidence of DLT, incidence and severity of adverse events (AE) and severe adverse events (SAE), clinically significant abnormal laboratory changes and other tests

  2 years

• Maximum Tolerated Dose (MTD) or Optimal Biological Effect Dose (OBD) and Phase II study recommended dose (RP2D)

  The safety, pharmacokinetic and preliminary efficacy data of the comprehensive dose escalation were determined. When MTD/OBD is determined, MTD/OBD is usually used as RP2D.

  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

Study Arms (4)

Dose Escalation: dose level：0.3mg/kg

EXPERIMENTAL

Dose Escalation: 0.3mg/kg, IV infusion, every 3 weeks (q3w).

Biological: JS019

Dose Escalation: dose level：1 mg/kg

EXPERIMENTAL

Dose Escalation: 1 mg/kg IV infusion, every 3 weeks (q3w).

Biological: JS019

Dose Escalation: dose level：3 mg/kg

EXPERIMENTAL

Dose Escalation: 3 mg/kg IV infusion, every 3 weeks (q3w).

Biological: JS019

Dose Escalation: dose level：10 mg/kg

EXPERIMENTAL

Dose Escalation: 10 mg/kg IV infusion, every 3 weeks (q3w).

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.

Dose Escalation: dose level：0.3mg/kg; Dose Escalation: dose level：1 mg/kg; Dose Escalation: dose level：10 mg/kg; Dose Escalation: dose level：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
• Failed or unsuitable for standard 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 ;

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.);

Sponsors & Collaborators

• Suzhou Kebo Ruijun Biotechnology Co., Ltd: lead

Study Sites (1)

Guangdong General Hospital

Guangdong, Guangzhou, 510062, China

RECRUITING

Central Study Contacts

Yilong Wu, bachelor's degree

CONTACT

86020-83877855; syylwu@live.cn

Huajun Chen, Doctor of Medicine

CONTACT

8613710581145; chenhuajun@gdph.org.cn

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: August 10, 2022
• First Posted: August 19, 2022
• Study Start: March 29, 2022
• Primary Completion: June 15, 2024
• Study Completion: August 10, 2024
• Last Updated: August 19, 2022

Record last verified: 2022-04

Locations

CN (1)