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Not yet recruiting NCT07676903

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

Phase I Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-4685.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Drug SHR-4685
    SHR-4685, in different doses.

Primary outcome measures

  • Dose-limiting toxicity (DLT) of SHR-4685. [Time frame: Up to 21 days.]
  • Maximum tolerated dose (MTD) of SHR-4685. [Time frame: Up to 24 months.]
  • Recommended Phase II Dose (RP2D) of SHR-4685. [Time frame: Up to 24 months.]
  • Adverse events (AEs). [Time frame: From the first drug administration to within 30 days for the last treatment dose, up to 24 months.]
  • Serious adverse events (SAEs). [Time frame: From the first drug administration to within 30 days for the last treatment dose, up to 24 months.]
Secondary outcome measures (8)
  • The concentration of SHR-4685 in plasma will be determined. [Time frame: At predefined intervals throughout the treatment period, up to 24 months.]
  • Time to maximum concentration (Tmax). [Time frame: 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). [Time frame: At predefined intervals throughout the treatment period, up to 24 months.]
  • The concentration of Anti-SHR-4685 antibodies (ADA) in plasma will be determined. [Time frame: At predefined intervals throughout the treatment period, up to 24 months.]
  • Objective Response Rate (ORR). [Time frame: Up to 24 months.]
  • Disease control rate (DCR). [Time frame: Up to 24 months.]
  • Duration of response (DoR). [Time frame: Up to 24 months.]
  • Progression Free Survival (PFS). [Time frame: Up to 24 months.]

Eligibility criteria

Inclusion criteria

  • Have fully understood this study and voluntarily signed the informed consent form, with good compliance and cooperation with follow-up;
  • Age 18-75 years, any gender;
  • Performance status ECOG score 0 or 1;
  • Expected survival time greater than 3 months;
  • Presence of at least one measurable lesion according to RECIST 1.1 criteria;
  • Have adequate organ function;
  • 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

  • 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;
  • Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 or to the level specified in the inclusion/exclusion criteria;
  • Presence of central nervous system (CNS) metastases;
  • Concurrent active malignancy other than the primary tumor;
  • History of central nervous system diseases within 12 months prior to screening;
  • 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;
  • Participants with active tuberculosis or a history of active tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment;
  • Presence of any significant clinical or laboratory abnormality that, in the investigator's opinion, affects safety evaluation;
  • History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;
  • 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;
  • Active chronic hepatitis B or active hepatitis C;
  • Known history of hypersensitivity to any component of the formulations used in the study;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07676903 · SHR-4685-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗