RO7119929
DrugRO7119929 will be administered orally as a capsule
NCT Number: NCT04338685
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Rigshospitalet; Onkologisk Klinik, København Ø, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
alopecia, peripheral neuropathy, any laboratory changes that still lie within the inclusion criteria defined above
RO7119929 will be administered orally as a capsule
Tocilizumab will be administered in case of severe steroid-refractory cytokine release syndrome.
Tocilizumab will be administered as concentrate for solution for IV infusion at a dose: for participants > 30 kg: 8 mg/kg, for participants < 30 kg: 12mg/kg IV
Other names: Actemra
Time frame: Baseline up to approximately 14 months
A DLT is defined as a clinically significant AE (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v.5.0) or significant laboratory abnormality 1) occurring during an assessment period of 21 days or 28 days after first dose of study treatment, respectively, and 2) is not attributed to disease progression, concomitant illness or another clearly identifiable cause.
Time frame: Baseline up to approximately 14 months
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Time frame: Baseline up to approximately 14 months
Progression-free survival (PFS) is defined as the time from randomization to disease progression or death from any cause.
Time frame: Baseline up to approximately 14 months
ORR is defined as the number of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more).
Time frame: Baseline up to approximately 14 months
Overall survival (OS) is defined as the time from randomization to death
Hoffmann-La Roche
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03741088
Adenocarcinoma, Carcinoma
Esplugues de Llobregat, Barcelona, Spain
View Trial DetailsNCT07727759
Adenocarcinoma, Carcinoma
Minya, Minya Governorate, Egypt
View Trial DetailsNCT07745153
Adenocarcinoma, Carcinoma
Guangzhou, Guangdong, China
View Trial DetailsNCT01171651
Adenocarcinoma, Carcinoma
Busan, South Korea
View Trial Details