Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma(HCC)

NCT03893695 | Completed Phase 1

• 1 other identifier: GT90001-TW-1001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

This single arm, open label, two stage study will be conducted in several medical centers around Taiwan. Stage one determine safety and tolerability in patients with HCC, and stage two assess anti-tumor activities of GT90001 in combination with nivolumab in patients with metastatic HCC. Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study.

Conditions

Metastatic Hepatocellular Carcinoma; HCC; Combinations of Drugs; Dependence

Keywords

Phase Ib/II; HCC; Metastatic Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Dose-limiting Toxicity(DLT)

  Each dose cohort will initially include 6 evaluable patients for assessment of toxicity within the 28 days following the first dose of nivolumab and GT90001.

  28 days

Secondary Outcomes (15)

• overall response rate (ORR)

  2 years

• the duration of response (DOR),

  2 years

• disease control rate (DCR),

  2 years

• time to response (TTR)

  2 years

• progression-free survival (PFS)

  2 years

Study Arms (1)

metastatic HCC

EXPERIMENTAL

Stage one - Dose de-escalation: Each dose cohort will assess toxicity within the 28 days following the first dose of nivolumab and GT90001. Stage two- the expansion cohort: 14 patients will be enrolled to the expansion cohort where one or no DLT takes place in planned study cohort.

Drug: GT90001 and Nivolumab

Interventions

GT90001 and Nivolumab DRUG

Stage1:Dose de-escalation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.

Also known as: GT90001 and Opdivo

metastatic HCC

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent for the trial;
• Age ≥20 years male and female;
• Subjects must have confirmed diagnosis of unresectable HCC with any of following criteria:
• i. Histologically or cytologically confirmed diagnosis of HCC ii. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy;
• Have documented disease progression or intolerance after first-line systemic treatment;
• At least one measurable lesion based on RECIST version 1.1 ;
• Child-Pugh score ≤ 6 (Child-Pugh A)score within 7 days of first dose of study drug;
• ECOG performance status: 0-1;
• Have a predicted life expectancy of greater than 3 months;
• The functions of the important organs are confirmed with the following requirement:
• Hemoglobin (HGB) ≥ 90 g/L;
• White blood cell count (WBC) ≥ 3×10\^9/L；
• Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L；
• Platelets (PLT) ≥ 100×10\^9/L；
• Total bilirubin (TBIL) ≤ 1.5× Upper limit of normal value (ULN)

You may not qualify if:

• Imaging findings for HCC corresponding to any of the following:
• HCC with ≥ 50% liver occupation
• Clear invasion into the bile duct
• Portal vein invasion or thrombosis at the main portal branch (Vp4)
• Gastric or esophageal varices that require treatment;
• If prior history of DVT/PE, the patient needs to be on stable doses of anticoagulation with low molecular weight heparin or oral anticoagulant for at least two weeks;
• Esophageal vein dilation, grade A of active peptic ulcer rating, and all bleeding risk by gastroscopy;
• History of arterial thromboembolic event in past 6 months;
• Active bleeding disorder, including gastrointestinal bleeding event or active hemoptysis within 28 days prior to study treatment;
• Have central nervous system (CNS) metastases;
• Has a known history of human immunodeficiency virus (HIV);
• Has received prior immune checkpoint inhibitor (including those targeting PD-1, PD-L1 or PD-L2, CD137, or cytotoxic T-lymphocyte antigen \[CTLA-4\]);
• Has a known history of, or any evidence of, interstitial lung disease or active non- infectious pneumonitis;
• Has active autoimmune disease that has required systemic treatment in past 2 years;
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial;

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (3)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MacKay Memorial Hospital

Taipei, Taiwan

Location

National TaiWan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Hsu C, Chang YF, Yen CJ, Xu YW, Dong M, Tong YZ. Combination of GT90001 and nivolumab in patients with advanced hepatocellular carcinoma: a multicenter, single-arm, phase 1b/2 study. BMC Med. 2023 Oct 20;21(1):395. doi: 10.1186/s12916-023-03098-w.

  PMID: 37858184 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yuwei Xu

  Suzhou Kintor Pharmaceuticals,inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, Open label,Two stage study

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 28, 2019
• Study Start: May 25, 2019
• Primary Completion: May 26, 2022
• Study Completion: September 27, 2022
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

TW (3)