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

Phase 1

Recruiting

• Conditions: Advanced Solid Cancer
• Interventions: Drug: JS015

• Registration Number: NCT05770310
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-01
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15
• Primary Completion: 2024-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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.,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JS015	JS015	-

Primary Outcome Measures

Name	Time	Method
dose-limiting toxicity （DLT）、adverse event（AE）、serious adverse event（SAE）	2Years	incidence and severity of DLT, adverse events (AE), serious adverse events (SAE), Abnormal changes in laboratory and other tests with clinical significance
Maximum tolerated dose (MTD),RP2D	2 Years	Maximum tolerated dose (MTD), Recommended dose for phase II trial

Secondary Outcome Measures

Name	Time	Method
time to peak（Tmax）	2 years	After a single dose, the time of peak blood concentration
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)	2 years	Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
immunogenicity	2 years	Incidence of Anti-Drug Antibody (ADA)
Peak concentration（Cmax）	2 years	The highest plasma drug concentration that can be achieved after medication
elimination half life（t1/2）	2 years	the time it takes the blood to reduce the concentration of the drug to half
overall survival (OS)	2 years	The time from randomization to death from any cause

Trial Locations

Locations (4)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Shandong Cancer Hospital; 🇨🇳 Jinan, Shandong, China

Shanghai Oriental Hospital; 🇨🇳 Shanghai, Shanghai, China

Affiliated Cancer Hospital of Harbin Medical University; 🇨🇳 Ha'erbin, Heilongjiang, China