Evaluating SHR-1681 for patients with advanced 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 is an open-label, multicenter Phase I/II clinical trial designed to assess the safety, tolerability, pharmacokinetics, and efficacy of SHR-1681 for injection in patients suffering from advanced solid tumors. The study will enroll participants with unresectable locally advanced or metastatic solid tumors that have either relapsed, are refractory to standard treatments, or for which no standard treatment is applicable. Participants will be monitored for measurable tumor lesions and must meet specific health criteria to ensure their eligibility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
2. Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
3. Have at least one measurable tumor lesion per RECIST v1.1;
4. ECOG performance score of 0-1;
5. Life expectancy ≥ 3 months;
6. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Subjects with active central nervous system metastases or meningeal metastases;
2. History of serious cardiovascular and cerebrovascular diseases;
3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
4. Severe infection within 4 weeks prior to the first dose;
5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Where it's running

• Shanghai Dongfang Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Fei Qiu
• Email: fei.qiu@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.