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A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors

A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of SHR-1501 in Combination With SHR-1316 in Patients With Advanced Malignancies

NCT03995472•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in combination with SHR-1316 in patients with advanced malignancies and to provide a recommended dose (RP2D) for subsequent clinical studies.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All Patients All patients must meet all the following criteria to be eligible to participate:
•1. Voluntarily participate in this clinical study, understand the research procedure and be able to sign informed consent in writing;
•2. Subjects must be willing and able to follow the research protocol;
•3. Aged 18-75 years old when the informed consent form is signed;
•4. Have a histologically or cytologically confirmed diagnosis of advanced or metastatic tumor malignancy;
•5. Patients' malignancies must be relapsed or refractory to standard treatment, or patients cannot tolerate standard treatment, or patients have actively refused standard therapy;
•6. FFPE tumor tissue or unstained slides of tumor sample must be obtained from patients enrolled in the dose expansion or indication expansion stage, both preserved samples collected within 6 months before the first dose (or up to 12 months prior to the first dose) and fresh samples (preferred) are acceptable;
•7. Eastern Cooperative Oncology Group ECOG PS score of 0-1;
•8. Have a life expectancy of ≥ 12 weeks;
•9. Adequate organ function defined according to the protocol, These results should be completed within 14 days prior to the first study treatment:
+1 more criteria

Exclusion Criteria

•1. Patients with cancerous meningitis (ie meningeal metastasis);
•2. Patients with active central nervous system (CNS) metastasis.
•3. Spinal cord compression that cannot be radically treated with surgery and/or radiotherapy cannot be enrolled.
•4. Patients with double cancer or more serious cancer;
•5. Patients with a history of autoimmune diseases;
•6. Significant clinical significance in the history of cardiovascular disease;
•7. Arterial/venous thrombosis events such as cerebrovascular accidents deep vein thrombosis and pulmonary embolism within 6 months prior to first administration;
•8. Have a history of immunodeficiency including HIV infection;
•9. Active hepatitis B or hepatitis C patients;
•10. Any disease or symptom that is not appropriate for inclusion in this study determined by the investigator.;
+9 more criteria

Locations (5)

Sydney Southwest Private Hospital

Liverpool, New South Wales, Australia

Scientia Clinical Research

Randwick, New South Wales, Australia

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

John Flynn Private Hospital

Tugun, Queensland, Australia

Guangdong General Hospital & Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, China

Key Dates

Start Date

February 14, 2020

Primary Completion Date

January 12, 2023

Completion Date

January 12, 2023

Last Updated

September 28, 2023

Enrollment

ACTUAL participants

Conditions

Advanced Malignancies

Interventions

SHR-1501

DRUG

SHR-1316

DRUG

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

NCT04752826

Advanced MalignanciesOvarian Cancer+2 more

View study

RECRUITINGPHASE1

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

NCT06458712

Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases)

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: September 28, 2023Data 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.

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A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors

Inclusion Criteria

Exclusion Criteria

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

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A Study of IBI363 in Subjects With Advanced Malignancies

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Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)