A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases

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Brief Title

A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases

Official Title

A First In Human, Open Label, Dose Escalation Phase I Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Clinical Activity Profile Of Single Agent RO7119929 (TLR7 Agonist) Administered Orally To Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases

Brief Summary

      Phase I study of RO7119929 given orally to participants with unresectable advanced or
      metastatic primary liver cancers and other solid tumors with predominant liver involvement.
      The primary objective of the study is to explore the safety and to determine the maximum
      tolerated dose (MTD) and/or optimal biologic dose (OBD) of RO7119929 as single agent.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Nature and Frequency of Dose-Limiting Toxicities

Secondary Outcome

 Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929

Condition

Carcinoma, Hepatocellular

Intervention

RO7119929

Study Arms / Comparison Groups

 RO7119929
Description:  Participants will receive RO7119929 every week in 3-week cycles. In Part A (dose-escalation on a weekly schedule) maximum tolerated dose (MTD) and/or recommended dose for expansion cohorts (RDE) will be determined. Following determination of MTD and/or RDE, treatment will commence at up to three different doses in specific expansion cohorts of participants for extended PD analysis (Part B).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

July 16, 2020

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of one of the following: unresectable advanced or
             metastatic HCC (including fibrolamellar HCC) not amenable to a curative treatment
             approach, unresectable advanced or metastatic intrahepatic or perihilar (Klatskin) BTC
             not amenable to a curative treatment approach, extrahepatic BTC or gallbladder cancer
             infiltrating the liver or metastasized into the liver with predominant liver disease,
             not amenable to a curative treatment approach, metastasized colorectal cancer (CRC),
             pancreatic ductal adenocarcinoma (PDAC), Gastric cancer (GC), renal cell carcinoma
             (RCC), triple negative breast cancer (TNBC), cutaneous melanoma, or ocular melanoma
             with predominant liver disease not amenable to a curative treatment approach.
             Participants with other solid tumors with predominant liver disease not amenable to a
             curative treatment approach might be enrolled after Sponsor approval

          -  Measurable disease with at least one measurable locally untreated liver lesion, as
             defined by RECIST v1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Adequate hematologic and major organ functions

          -  Participants for which there is no available standard therapy likely to confer
             clinical benefit, or participants who are not candidates for such available therapy

          -  Life expectancy of ≥12 weeks, approximated with Royal Marsden Hospital score 0-1 or
             Gustave Roussy Immune (GRIm) score 0-1. Participants with a Royal Marsden Hospital or
             GRIm score of ≥2 and a life expectancy of ≥12 weeks according to the investigator's
             clinical judgement may be enrolled after Medical Monitor approval has been obtained.

          -  For participants with HCC: Child-Pugh score of A6 or better

        Exclusion Criteria:

          -  History or clinical evidence of central nervous system (CNS) primary tumors or
             metastases including leptomeningeal metastases, unless they have been previously
             treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing
             anticonvulsants in the last 14 days prior to Screening

          -  Evidence of any extra-hepatic primary tumor or metastasis requiring prompt medical
             intervention

          -  Receipt of prior therapy with a TLR7/8/9 agonist and/or IFN-alpha

          -  Prior chemotherapy, antibody, or other registered or experimental cancer treatment
             within 3 weeks of study Cycle 1 Day 1. Specifically, no CPI antibody is allowed to be
             administered within 6 weeks of study Cycle 1 Day 1

          -  Receipt of investigational agent for any other indication within 3 weeks of dosing

          -  Treatment with systemic immunosuppressive medication (including, but not limited to,
             corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
             anti-TNF-alpha agents) within 2 weeks prior to initiation of study treatment, or
             anticipation of need for systemic immunosuppressive medication during study treatment

          -  Local therapy to liver (e.g. radiofrequency ablation, percutaneuous ethanol or acetic
             acid injection, cryoablation, high-intensity focused ultrasound, transarterial
             chemoembolization, and transarterial embolization) within 3 weeks prior to initiation
             of study treatment, radioembolization within 3 months prior to initiation of study
             treatment, or non-recovery from side effects of such procedure

          -  Treatment-related toxicities from prior cancer therapy that have not resolved to 					

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clinical Trials, 888-662-6728 (U.S. and Canada), [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04338685

Organization ID

WP41377


Responsible Party

Sponsor

Study Sponsor

Hoffmann-La Roche


Study Sponsor

Clinical Trials, Study Director, Hoffmann-La Roche


Verification Date

September 2021