A Clinical Study of SHR-4685 on Safety, Tolerability and Pharmacokinetics in Participants With Solid Tumors

A Phase I Clinical Study of SHR-4685 on Safety, Tolerability and Pharmacokinetics in Participants With Solid Tumors

The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of SHR-4685 in participants with advanced solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: SHR-4685

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yifan Shen, M.D; Phone Number: +86-0518-82342973; Email: yifan.shen.ys18@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
      • Principal Investigator: Lin Shen
      • Contact: Lin Shen; Phone Number: +86-010-88196561; Email: doctorshenlin@sina.cn
      • Contact: Shaohua Ma; Phone Number: +86-13501090276; Email: doctor_msh@bjmu.edu.cn
      • Principal Investigator: Shaohua Ma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Have fully understood this study and voluntarily signed the informed consent form, with good compliance and cooperation with follow-up;
2. Age 18-75 years, any gender;
3. Performance status ECOG score 0 or 1;
4. Expected survival time greater than 3 months;
5. Presence of at least one measurable lesion according to RECIST 1.1 criteria;
6. Have adequate organ function;
7. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose; and must not be lactating.

Exclusion Criteria:

1. Participants who have received any approved anti-tumor drugs (including investigational anti-tumor drugs) within 4 weeks prior to the first dose of the IP;
2. Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 or to the level specified in the inclusion/exclusion criteria;
3. Presence of central nervous system (CNS) metastases;
4. Concurrent active malignancy other than the primary tumor;
5. History of central nervous system diseases within 12 months prior to screening;
6. Participants who have undergone major surgery other than diagnostic or biopsy procedures within 28 days prior to the first dose, or who are expected to undergo major surgery during the study;
7. Participants with active tuberculosis or a history of active tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment;
8. Presence of any significant clinical or laboratory abnormality that, in the investigator's opinion, affects safety evaluation;
9. History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
11. Positive for human immunodeficiency virus (HIV) (HIV1/2 antibodies) with CD4+ T lymphocyte count <350 cells/uL; or history of other acquired/congenital immunodeficiency diseases; or history of allogeneic bone marrow or solid organ transplantation;
12. Active chronic hepatitis B or active hepatitis C;
13. Known history of hypersensitivity to any component of the formulations used in the study;
14. Other factors, in the opinion of the investigator, that may affect the study results or result in forced halfway termination of this study, such as alcoholism, drug abuse, suffering from other serious diseases (including psychiatric disorders) requiring concomitant treatment, seriously abnormal laboratory test values, family or social factors and other conditions that may affect the safety of the patient or collection of study data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-4685 group; Participants will receive SHR-4685 in different doses.	Drug: SHR-4685; SHR-4685, in different doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicity (DLT) of SHR-4685.	Up to 21 days.
Maximum tolerated dose (MTD) of SHR-4685.	Up to 24 months.
Recommended Phase II Dose (RP2D) of SHR-4685.	Up to 24 months.
Adverse events (AEs).	From the first drug administration to within 30 days for the last treatment dose, up to 24 months.
Serious adverse events (SAEs).	From the first drug administration to within 30 days for the last treatment dose, up to 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concentration of SHR-4685 in plasma will be determined.	Cmax will be derived.	At predefined intervals throughout the treatment period, up to 24 months.
Time to maximum concentration (Tmax).	Evaluation of pharmacokinetic parameter of SHR-4685.	At predefined intervals throughout the treatment period, up to 24 months.
Area under the concentration-time curve from time 0 to time t (time of the last measurable concentration) (AUC0-t).	Evaluation of pharmacokinetic parameter of SHR-4685. The concentration of SHR-4685 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.	At predefined intervals throughout the treatment period, up to 24 months.
The concentration of Anti-SHR-4685 antibodies (ADA) in plasma will be determined.		At predefined intervals throughout the treatment period, up to 24 months.
Objective Response Rate (ORR).	Complete Response (CR) and Partial Response (PR) based on RECIST 1.1.	Up to 24 months.
Disease control rate (DCR).	Complete Response (CR), Partial Response (PR) and Stable Disease (SD) based on RECIST 1.1.	Up to 24 months.
Duration of response (DoR).	Time from documentation of tumor response to disease progression assessed among patients who had an objective response.	Up to 24 months.
Progression Free Survival (PFS).	Time from C1D1 to first assessment of disease progression or death, whichever is earlier.	Up to 24 months.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SHR-4685-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No