Phase 1/2a study to evaluate the safety, activity, and pharmacokinetics of escalating doses of GNS561 in patients with primary or secondary liver cancer

GENOSCIENCE PHARMA0 sites122 target enrollmentOctober 6, 2017

ConditionsHepatocellular carcinomaIntrahepatic cholangiocarcinomaPancreatic adenocarcinoma with liver metastasisColorectal cancer with liver metastasis MedDRA version: 20.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864 MedDRA version: 20.0Level: LLTClassification code 10077738Term: Hepatocellular carcinoma metastaticSystem Organ Class: 100000004864 MedDRA version: 20.0Level: LLTClassification code 10073077Term: Intrahepatic cholangiocarcinomaSystem Organ Class: 100000004864 MedDRA version: 20.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864 MedDRA version: 20.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatocellular carcinomaIntrahepatic cholangiocarcinomaPancreatic adenocarcinoma with liver metastasisColorectal cancer with liver metastasis
Sponsor: GENOSCIENCE PHARMA
Enrollment: 122
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 6, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GENOSCIENCE PHARMA

Eligibility Criteria

Inclusion Criteria

•1\. Males or females \= 18 years of age.
•2\. Histologically confirmed and documented locally advanced or metastatic hepatocarcinoma (HCC) that is deemed not appropriate for curative therapy or histologically confirmed and documented locally advanced or metastatic intrahepatic carcinoma (iCCA) or or histologically confirmed and documented pancreatic ductal adenocarcinoma (PDAC) with liver metastasis or histologically confirmed and documented colorectal cancer (CRC) with liver metastasis.
•3\. Liver tumor burden \< 50% of the liver (per Investigator judgment).
•4\. Antiviral therapy required in Hepatitis B virus patients (Hepatitis B antigen positive)
•5\. Child\-Pugh score A (\= 6, Appendix C), with no evidence of prior cirrhotic decompensation within last 12 months prior to enrollment.
•6\. a. Previously exposed, intolerant or refractory to at least another registered therapy and for which no curative therapy is available for HCC.
•b. Previously exposed, intolerant or refractory to at least one first line chemotherapy for ICC.
•c. Previously exposed, intolerant or refractory to at least one first line chemotherapy and for which no curative therapy is available for PDAC patients.
•d. Previously exposed, intolerant or refractory to at least one first line chemotherapy with fluoropyrimidine and/or oxaliplatin and/or irinotecan and for which no curative therapy is available for CRC patients.
•7\. Neither sorafenib nor other anticancer therapy such as chemotherapy in the 4 weeks or 5 half\-lives, whichever is greater, prior to the first dose of GNS561\. This treatment\-free period must be extended to 6 weeks in the case of nitrosoureas and 8 weeks for previous treatment with monoclonal antibodies. The following treatment is allowed: palliative radiation to bone metastases within 2 weeks prior to first dose.

Exclusion Criteria

•1\. Pregnant or breast\-feeding mothers
•2\. Prior history of acrodermatitis enteropathica or known ZIP4 genetic mutations
•3\. Any known history of encephalopathy
•4\. Known esophageal varices with recent history of bleeding (within previous 2 months)
•5\. Clinically significant ascites or paracentesis
•6\. Concurrent hematologic malignancies or other malignancy, with the exception of:
•a) Curatively resected non\-melanoma skin cancer;
•b) Curatively treated cervical carcinoma in situ.
•7\. Known untreated or symptomatic brain metastases
•8\. Prior antitumor treatment, including chemotherapy, biologic, experimental, hormonal or radiotherapy within 4 weeks of first dose of GNS561with the following exceptions: