SHR-4685 safety in adults with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human phase 1 trial evaluates safety, tolerability, and pharmacokinetics of SHR-4685 in adults with advanced solid tumors. Eligible participants have measurable disease, adequate organ function, and a decent performance status, and must meet pregnancy requirements for women of childbearing potential. The study excludes those who recently received anti-tumor therapy, has CNS metastases, or another active malignancy. Investigational drug dosing and monitoring will occur at multiple sites in Australia, under single-cohort enrollment with close safety assessments. Results will inform dosing and safety profile for further development.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Macquarie University Hospital
  North Ryde, New South Wales, Australia Not yet recruiting
• GenesisCare North Shore
  St Leonards, New South Wales, Australia Not yet recruiting
• Icon Cancer Centre South Brisbane
  South Brisbane, Queensland, Australia Not yet recruiting
• Cancer Research SA
  Adelaide, South Australia, Australia Not yet recruiting
• Epworth HealthCare - Richmond
  Richmond, Victoria, Australia Not yet recruiting

Study contacts

• Study coordinator: Ran Zhao, M.D
• Email: ran.zhao.rz7@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.