Carcinoma, HepatocellularPhase 1NCT04338685
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
A Phase 1 study testing RO7119929 and Tocilizumab in people with Carcinoma, Hepatocellular and Biliary Tract Cancer, run by Hoffmann-La Roche at 10 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Biliary Tract Cancer, Secondary Liver Cancer
- What is being tested?
- RO7119929 and Tocilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 16 Jul 2020to 9 Jan 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 </= Grade 1 CTC AE prior to study treatment with the exception of the following Grade 2 toxicities:
- alopecia, peripheral neuropathy, any laboratory changes that still lie within the inclusion criteria defined above
- History of other malignancy within 2 years; exception for ductal carcinoma in situ not requiring chemotherapy, low grade cervical intraepithelial neoplasia (CIN), nonmelanoma skin cancer, low grade localized prostate cancer (Gleason score < Grade 7), or optimally treated Stage 1 uterine cancer.
- Active or history of immunologic-mediated disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome or Guillain-Barré syndrome
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection.
- Ascites, pleural effusion, or pericardial effusion requiring medical intervention within 12 months prior to study entry.
- History of human immunodeficiency virus (HIV) infection
- Active hepatitis B virus (HBV) infection
- Coinfection of HBV and hepatitis C virus (HCV).
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Spain3 sites
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, 08035
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
Clínica Universidad de Navarra
Pamplona, Navarre, 31620
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Taiwan2 sites
National Taiwan Uni Hospital
Taipei, 10041
Tri-Service General Hospital
Taipei, 11490
United States1 site
City of Hope Cancer Center
Duarte, California, 91010
About this study
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
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.
- Being tested
- RO7119929, Tocilizumab
- Keywords
- TLR7 Agonist
- Medical subject headings
- Carcinoma, Hepatocellular, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7119929Drug
RO7119929 will be administered orally as a capsule
TocilizumabDrug
Also called Actemra
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
| Study group | Role | What they receive |
|---|---|---|
| Part A1-1 mg RO7119929 | Experimental | Participants received 1mg RO7119929 every week in 3-week cycles. Receives: Drug: RO7119929 |
| Part A1-3 mg RO7119929 | Experimental | Participants received 4 mg RO7119929 every week in 3-week cycles Receives: Drug: RO7119929 |
| Part A1 - 6 mg RO7119929 | Experimental | Participants received 6 mg RO7119929 every week in 3-week cycles Receives: Drug: RO7119929 |
| Part A1 -9 mg RO7119929 | Experimental | Participants received 9 mg RO7119929 every week in 3-week cycles Receives: Drug: RO7119929 |
| Part B1-5 mg RO7119929 | Experimental | Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12 Receives: Drug: RO7119929 |
| Part A2- 2/5/5 mg RO7119929 | Experimental | Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1. Receives: Drug: RO7119929 |
| Part A2- 2/5/6 mg RO7119929 | Experimental | Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1. Receives: Drug: RO7119929 |
| Part A3-4 mg RO7119929 | Experimental | Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles Receives: Drug: RO7119929; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLT)
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.
Measured: Baseline up to approximately 14 months
Number of Participants With Adverse Events (AEs) According To NCI CTCAE v5.0
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.
Measured: Baseline up to approximately 14 months
Secondary outcomes (11)
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929
Measured: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Measured: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929
Measured: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Measured: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929
Measured: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Measured: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929
Measured: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Measured: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Progression-Free Survival (PFS) According to RECIST v1.1
Progression-free survival (PFS) is defined as the time from randomization to disease progression or death from any cause.
Measured: Baseline up to approximately 14 months
Objective Response Rate (ORR) According to RECIST v1.1
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).
Measured: Baseline up to approximately 14 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death
Measured: Baseline up to approximately 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start16 Jul 2020
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Open label, multi-center, single-arm, multiple-ascending dose escalation
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338685
- Sponsor's protocol ID
- WP41377
- Status last verified
- Oct 2024
- First submitted
- 6 Apr 2020
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoo C, Fabregat-Franco C, Lin CC, Qvortrup C, Oh DY, Yau T, Kim HD, Castet F, Ponz Sarvise M, Hsu C, Rohrberg KS, Lichtenegger FS, Franjkovic I, Kratochwil NA, Bessa J, Rossmann E, Schwalie PC, Rieder N, Poschinger T, Sie CG, Dettling S, Schlenker R, Jiang T, Dai C, Yun H, Hall E, Yeo Te-Ying A, Hoves S, Cannarile MA, Schiff C, Sangro B. First-in-human phase 1 study of RO7119929, an oral TLR7 agonist prodrug, in patients with advanced primary or metastatic liver cancers. J Immunother Cancer. 2026 Mar 9;14(3):e012783. doi: 10.1136/jitc-2025-012783.
PubMed 41802810
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04338685
- Acronym / sponsor ID
- WP41377
- Keywords
- TLR7 Agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Open label, multi-center, single-arm, multiple-ascending dose escalation
| Arm | Type | Receives |
|---|---|---|
| Part A1-1 mg RO7119929 | Experimental | Drug: RO7119929Participants received 1mg RO7119929 every week in 3-week cycles. |
| Part A1-3 mg RO7119929 | Experimental | Drug: RO7119929Participants received 4 mg RO7119929 every week in 3-week cycles |
| Part A1 - 6 mg RO7119929 | Experimental | Drug: RO7119929Participants received 6 mg RO7119929 every week in 3-week cycles |
| Part A1 -9 mg RO7119929 | Experimental | Drug: RO7119929Participants received 9 mg RO7119929 every week in 3-week cycles |
| Part B1-5 mg RO7119929 | Experimental | Drug: RO7119929Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12 |
| Part A2- 2/5/5 mg RO7119929 | Experimental | Drug: RO7119929Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1. |
| Part A2- 2/5/6 mg RO7119929 | Experimental | Drug: RO7119929Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1. |
| Part A3-4 mg RO7119929 | Experimental | Drug: RO7119929, Drug: TocilizumabParticipants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7119929RO7119929 will be administered orally as a capsule | Drug | Part A1 - 6 mg RO7119929, Part A1 -9 mg RO7119929, Part A1-1 mg RO7119929, Part A1-3 mg RO7119929, Part A2- 2/5/5 mg RO7119929, Part A2- 2/5/6 mg RO7119929, Part A3-4 mg RO7119929, Part B1-5 mg RO7119929 |
| TocilizumabAlso: ActemraTocilizumab 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 | Drug | Part A3-4 mg RO7119929 |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLT)
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.
Number of Participants With Adverse Events (AEs) According To NCI CTCAE v5.0
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.
11 secondary outcomes
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Progression-Free Survival (PFS) According to RECIST v1.1
Time frame: Baseline up to approximately 14 months
Objective Response Rate (ORR) According to RECIST v1.1
Time frame: Baseline up to approximately 14 months
Overall Survival (OS)
Time frame: Baseline up to approximately 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41802810Yoo C, Fabregat-Franco C, Lin CC, Qvortrup C, Oh DY, Yau T, Kim HD, Castet F, Ponz Sarvise M, Hsu C, Rohrberg KS, Lichtenegger FS, Franjkovic I, Kratochwil NA, Bessa J, Rossmann E, Schwalie PC, Rieder N, Poschinger T, Sie CG, Dettling S, Schlenker R, Jiang T, Dai C, Yun H, Hall E, Yeo Te-Ying A, Hoves S, Cannarile MA, Schiff C, Sangro B. First-in-human phase 1 study of RO7119929, an oral TLR7 agonist prodrug, in patients with advanced primary or metastatic liver cancers. J Immunother Cancer. 2026 Mar 9;14(3):e012783. doi: 10.1136/jitc-2025-012783.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7119929 and Tocilizumab in people with Carcinoma, Hepatocellular and Biliary Tract Cancer, run by Hoffmann-La Roche at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, South Korea, Taiwan, United States, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicities (DLT) (time frame: Baseline up to approximately 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.