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MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients

A Multicenter, Open-label, Phase I/II Dose Escalation and Expansion Clinical Study to Assess the Safety and Efficacy of MGD013 Monotherapy and in Combination With Brivanib Alaninate (ZL-2301) in Patients With Advanced Liver Cancer

NCT04212221•Zai Lab (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

This study consists of two parts: Phase I is a dose escalation study to determine the Recommended Phase II Dose (RP2D) of MGD013 monotherapy and that of MGD013 when in combination with Brivanib Alaninate (ZL-2301) in subjects with advanced liver cancer (including hepatocellular carcinoma and intrahepatic cholangiocarcinoma). Phase II is a dose expansion study and consists of two parts: Part 1 is to assess the safety and efficacy of MGD013 monotherapy and MGD013 in combination with ZL-2301 in subjects with advanced hepatocellular carcinoma (HCC); in Part 2, a therapeutic method (MGD013 monotherapy or MGD013 in combination with ZL-2301, determined by the sponsor according to the obtained data) will be selected for dose expansion study in HCC subjects who have previously failed immune checkpoint inhibitor treatment, to further evaluate the safety and efficacy of the study treatments in the specific group of subjects.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects who voluntarily sign the informed consent form (ICF);
•2. Male or female subjects who are aged 18-75 years old;
•3. Subjects with histologic, cytologic or clinical confirmed diagnosis of advanced HCC (Phase I could include intrahepatic cholangiocarcinoma or mixed hepatocellular-cholangiocarcinoma), and are not suitable for surgery or loco-regional therapy or have progressed following surgery and/or loco-regional therapy;
•4. Subject who has at least one measurable lesion according to RECIST v1.1 criteria.
•5. Phase I study: subjects who have previously received at least one line of systemic therapy, including immune checkpoint inhibitors, molecular targeted drugs or systematic chemotherapy, alone or in combination, and failed (progression confirmed by imaging) or were intolerant at the discretion of investigator; PhaseII：Advanced HCC cohort with subjects who have previously received immune checkpoint inhibitor treatment: subjects who have failed (progression confirmed by imaging) prior one line immune checkpoint inhibitor treatment, including anti-PD-1 antibody/anti-PD-L1 antibody and / or anti-CTLA-4 antibody, and/or molecular targeted therapy or systematic chemotherapy (monotherapy or in combination); Phase II: Advanced HCC cohort with subjects who have not previously received immune checkpoint inhibitor treatment: subjects who have failed (progression confirmed by imaging) or were intolerant to (at the discretion of investigator) previous molecular targeted therapy or systematic chemotherapy, without receiving immune checkpoint inhibitor treatment (including anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, and bispecific antibodies including the above targets).
•6. Previous anti-tumor therapy must be completed no less than 2 weeks prior to the study treatment and all adverse events related to previous treatment must have recovered to CTCAE Grade ≤1; if subjects who have received prior immune checkpoint inhibitors have immune-related endocrinopathy, it should be controlled with hormone replacement therapy.
•7. Phase I: Child-Pugh Class A; Phase II: Child-Pugh Class A or B with a score of ≤ 7;
•8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
•9. Subjects with life expectancy ≥12 weeks;
•10. Subjects with chronic HBV infection must have HBV-DNA \<500 IU/ml, and have received at least 14 days of anti-HBV treatment (e.g. entecavir, tenofovir) prior to the initiation of study treatment and are willing to receive antiviral treatment throughout the study; Subjects with RNA-positive HCV must have received standard antiviral treatment and the elevation of their liver enzymes must not exceed the level of CTCAE Grade 1;
+4 more criteria

Exclusion Criteria

•1. Subjects who have known fibrolamellar carcinoma of liver for phase I and subjects who have fibrolamellar carcinoma, mixed HCC- cholangiocarcinoma or cholangiocarcinoma for phase II;
•2. Subjects with brain metastasis or leptomeningeal metastasis confirmed by brain MRI during screening period;
•3. Subjects with a diagnosis of other malignant tumors within 5 years prior to first administration, except for skin basal cell carcinoma, skin squamous cell carcinoma and/or in situ cancer following radical resection;
•4. Subjects who had liver or other sites loco-regional treatment (including transcatheter arterial chemoembolization (TACE), transcatheter arterial embolization (TAE), hepatic artery infusion (HAI), local radiotherapy, radioembolization, radiofrequency ablation, cryoablation or percutaneous ethanol injection) , or who had major surgery of liver or other sites within 4 weeks prior to first administration, or had minor surgical procedures (e.g. simple excision, tooth extraction) within one week prior to first administration, or had received palliative radiotherapy for bone metastasis within 2 weeks and radiotherapy-related toxicity ≥ CTCAE Grade 2.
•5. Subjects who have moderate or severe ascites (detected by B-ultrasound or CT), or require therapeutic abdominal paracentesis or drainage;
•6. Subjects with a history of hepatic encephalopathy;
•7. Subjects with a history of unhealed wounds or ulcers or bone fractures within 3 months prior to study enrollment;
•8. Subjects who plan to have or had allogenic organ or bone marrow transplantation;
•9. Subjects who are at increased risk of bleeding or have history of thrombosis:
•(1) Clinically significant bleeding within 3 months prior to screening or clear bleeding tendency; (2) Gastrointestinal hemorrhage within 6 months prior to screening or clear tendency of gastrointestinal hemorrhage; (3) Arterial/venous thromboembolic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, etc.; (4) Require anticoagulation therapy with an agent such as warfarin or heparin; (5) Require chronic anti-platelet therapy (such as aspirin≥100 mg/day, clopidogrel, etc.); 10. Subjects who have clinically significant cardiovascular diseases:
+12 more criteria

Locations (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Key Dates

Start Date

April 20, 2020

Primary Completion Date

April 27, 2022

Completion Date

April 27, 2022

Last Updated

July 23, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Interventions

MGD013 monotherapy

DRUG

MGD013 in combination with Brivanib Alaninate

DRUG

HAI or IV of Adebrelimab, Combined with Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma

NCT06737913

Advanced Hepatocellular Carcinoma (HCC)

View study

TERMINATEDPHASE2

A Randomized, Placebo-controlled, Double-blind Phase 2 Study With OSI-906 in Patients With Advanced HCC

NCT01101906

Advanced Hepatocellular Carcinoma (HCC)

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UNKNOWNPHASE2

A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection (JS001) Combined With Bevacizumab as the First-line Therapy for Advanced Hepatocellular Carcinoma (HCC)

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: July 23, 2024Data 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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