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Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors

A Phase I Study to Characterize the Tolerance, Safety, Pharmacokinetics/Pharmacodynamics and Effect of PD-1 Inhibitor SHR-1210 in Combination With IDO Inhibitor SHR9146 and With/Without Apatinib in Patients With Advanced Solid Tumors (PIANO)

NCT03491631•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This phase I trial is designed to efficiently identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) for the combination therapy regimen of the IDO1 inhibitor SHR9146 when administered in combination with immune checkpoint PD-1 inhibitor SHR-1210 plus VEGFR inhibitor Apatinib or not in subjects with advanced/metastatic solid tumors. All subjects will receive the same standard SHR-1210 plus Apatinib (only three drugs group)regimen, while SHR9146 in doses increasing from 100 mg twice daily to, potentially, 600 mg twice daily. Once the recommended regimen has been identified, subjects with the selected tumor type will be enrolled into expansion cohorts based upon prior safety and tolerability data.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance).
•2. At least one measurable parameter according to RECIST 1.1.
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•4. Life expectancy of at least 12 weeks.
•5. Subjects must have normal organ and marrow function as defined below:
•1. Absolute neutrophil count \> 1,500/mcL
•2. Platelets \> 100,000/mcL
•3. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); for subjects with liver metastases, Total bilirubin≤ 2 x ULN,
•4. AST/ALT (SGOT/SGPT) ≤ 2.5 times institutional normal limits; for subjects with liver metastases, ALT and AST ≤ 5 × ULN
•5. Creatinine ≤ 1.5 times the ULN
+2 more criteria

Exclusion Criteria

•1. Known history of hypersensitivity to any components of SHR9146 and SHR-1210 formulation, or other antibody formulation.
•2. Prior exposure to any T cell co-stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies.
•3. Prior systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, surgery or target therapy within 4 weeks (Or 5 half-life of the drug, calculate the longer ) before the study drug administration, or any unresolved AEs \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
•4. Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
•5. Active brain metastasis or meningeal metastasis.
•6. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class \> 2), ventricular arrhythmia which need medical intervention.
•7. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.
•8. Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure \>/= 140 mm Hg and/or diastolic pressure \>/= 90 mm Hg). (group 2)
•9. Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency, such as: esophageal varices, local active ulcerative lesions, gastric ulcer and duodenal ulcer, the ulcerous colitis, gastrointestinal diseases such as portal hypertension or resection of tumor with bleeding risk, etc. (group 2)
•10. Previous Arterial/venous thrombosis events within 3 months. (group 2)
+1 more criteria

Locations (1)

Jilin Province Cancer Hospital

Changchun, Jilin, China

Key Dates

Start Date

November 20, 2018

Primary Completion Date

June 1, 2023

Completion Date

September 1, 2023

Last Updated

November 4, 2022

Enrollment

ACTUAL participants

Conditions

Tumor, SolidCancer, MetastaticNeoplasm Malignant

Interventions

SHR9146+SHR-1210

DRUG

SHR9146+SHR-1210+Apatinib

DRUG

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

NCT07209111

Neoplasm Malignant

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RECRUITINGPHASE1

Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors

NCT07348042

Tumor, Solid

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RECRUITINGPHASE1

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

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: November 4, 2022Data 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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Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer