Loading clinical trials...

A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors

A Phase I/II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors

NCT06737731•Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Shanghai Dongfang Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 21, 2025

Primary Completion Date

November 1, 2026

Completion Date

July 1, 2027

Last Updated

January 9, 2026

Enrollment

300

ESTIMATED participants

Conditions

Malignant Solid Tumors

Interventions

SHR-1681

DRUG

Contacts

Fei Qiu

CONTACT

+86-0518-82342973 fei.qiu@hengrui.com

Ting Lu, M.M

CONTACT

+86-18825721498 ting.lu@hengrui.com

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

NCT06658951

HER2-positive Advanced Malignant Solid Tumors

View study

RECRUITING

Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors

NCT03739827

Malignant Solid TumorsOther Neoplasms Solid Tumors+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors

Clinical Trial of IL - 22BP Safety, Tolerability, and Antitumor Activity in Refractory Solid Tumors.

MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors

A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors

Clinical Study of MNC-168 Enteric-coated Capsule in the Treatment of Advanced Intestinal Solid Tumor