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

Advanced Solid Cancer Clinical Trial

Official title:

A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS015 In Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770310
• Other study ID #: JS015-001-I
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: Kai Xu, Project manager
• Phone: +86 13761020175
• Email: kai_xu[@]junshipharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Willing to participate in this study and provide written informed consent;

2. Histologically- or cytologically-confirmed advanced solid tumors considered failure to the standard treatment, or with no standard treatment, or not available to standard treatment;

3. At least one measurable lesion according to RECIST 1.1;

4. Life expectancy = 3 months;

5. Eastern Cooperative Oncology Group (ECOG) 0 or 1;

6. Adequate organ function;

7. Treatment related toxicities due to prior anti-cancer therapy including surgery and radiotherapy must be = grade 1;

8. 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;

Exclusion Criteria:

1. Allergy or contraindication to JS015 and its ingredients;

2. Has a known additional malignancy in the last 5 years.

3. Pregnancy or lactation;

4. History of immunodeficiency, including human immunodeficiency virus(HIV) test positive, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;

5. Brain or meningeal metastases

6. Pleural effusion, peritoneal effusion or pericardial effusion that required treatment (such as puncture, drainage)

7. Severe cardiovascular and cerebrovascular diseases;

8. Previous antineoplastic therapy meets washout requirements.

9. 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 ;

10. Has active tuberculosis or hepatitis B (HBV) or hepatitis C (HCV);

11. moderate to severe that seriously affect lung function;

12. Other serious physical or mental diseases or laboratory abnormalities, or alcoholism, drug abuse, etc.,

Related Conditions & MeSH terms

• Advanced Solid Cancer

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Affiliated Cancer Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Shanghai Oriental Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.	Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum tolerated dose (MTD),RP2D	Maximum tolerated dose (MTD), Recommended dose for phase II trial	2 Years
Secondary	Peak concentration(Cmax)	The highest plasma drug concentration that can be achieved after medication	2 years
Secondary	time to peak(Tmax)	After a single dose, the time of peak blood concentration	2 years
Secondary	elimination half life(t1/2)	the time it takes the blood to reduce the concentration of the drug to half	2 years
Secondary	immunogenicity	Incidence of Anti-Drug Antibody (ADA)	2 years
Secondary	Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)	Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)	2 years
Secondary	overall survival (OS)	The time from randomization to death from any cause	2 years