Solid TumorsPhase 1NCT05129280
A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors
A Phase 1 study testing RO7444973 and Tocilizumab in people with Solid Tumors, run by Hoffmann-La Roche at 10 sites in 6 countries.
Trial summary
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- RO7444973 and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 25 Jan 2022to 12 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Unresectable and/or metastatic solid tumors that have received standard-of-care (SOC) therapies previously and have no other SOC options available
- Confirmed HLA-A*02:01 haplotype
- Confirmed MAGE-A4 expression
- Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Life expectancy of >/=12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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- Absence of rapid disease progression, threat to vital organs or non-irradiated lesions >2 cm in diameter at critical sites
- No significant ongoing toxicity from prior anticancer treatment
- Adequate hematological function
- Adequate liver function
- Adequate renal function
- If applicable, willingness to use contraceptive measures.
Who cannot join
- History or clinical evidence of CNS primary tumors or metastases
- Another invasive malignancy in the last 2 years
- Uncontrolled hypertension
- Significant cardiovascular disease
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection
- Current or past history of CNS disease
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- Dementia or altered mental status that would prohibit informed consent
- Active auto-immune disease or flare within 6 months prior to start of study treatment
- Expected need for regular immunosuppressive therapy or with systemic corticosteroids
- Insufficient washout from prior anti-cancer therapy
- Prior treatment with a bispecific T-cell engaging or adoptive cell therapy.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Belgium4 sites
Cliniques Universitaires St-Luc
Brussels, 1200
UZ Antwerpen
Edegem, 2650
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000
Spain2 sites
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, 28050
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United Kingdom1 site
Royal Marsden Hospital - Institute of Cancer Research - Sutton
Sutton, SM2 5PT
About this study
Official title: An Open-label, Multicenter, Phase I Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A*02:01 allele.
- Conditions
- Solid Tumors
- Being tested
- RO7444973, Tocilizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7444973Drug
RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort.
TocilizumabDrug
Also called Actemra, RoActemra
Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg.
| Study group | Role | What they receive |
|---|---|---|
| Part I: Single Participant Cohort (SPC) Dose Escalation | Experimental | In Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level. Receives: Drug: RO7444973; Drug: Tocilizumab |
| Part II: Multiple Participant Cohort (MPC) Dose Escalation | Experimental | In Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored. Receives: Drug: RO7444973; Drug: Tocilizumab |
| Part III: Recommended Phase 2 Dose (RP2D) Expansion | Experimental | Based on emerging data from Part II, an RP2D and dosing regimen will be further investigated in Part III. Receives: Drug: RO7444973; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From start of treatment up to 90 days after last RO7444973 dose (up to 15 months)
Number of Participants With Dose-limiting Toxicities (DLTs)
Measured: From start of treatment up to 21-28 days
Secondary outcomes (7)
Objective Response Rate (ORR)
Measured: From baseline up to 12 months
Disease Control Rate (DCR)
Measured: From baseline up to 12 months
Duration of Response (DoR)
Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 40 months)
Progression-free Survival (PFS)
Measured: From baseline to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months)
Overall Survival (OS)
Measured: From baseline to death from any cause (up to 40 months)
Pharmacokinetics (PK): Serum Concentration of RO7444973 Over Time
Measured: From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months)
Change from Baseline in Percentage of Participants Positive for Anti-drug Antibodies (ADA) to RO7444973
Measured: From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start25 Jan 2022
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Why it stopped: The study was terminated due to program discontinuation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT05129280
- Sponsor's protocol ID
- BE43244
- Other IDs
- 2021-000624-35
- Status last verified
- Aug 2023
- First submitted
- 19 Nov 2021
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors
- ClinicalTrials.gov ID
- NCT05129280
- Acronym / sponsor ID
- BE43244
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to program discontinuation.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A*02:01 allele.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I: Single Participant Cohort (SPC) Dose Escalation | Experimental | Drug: RO7444973, Drug: TocilizumabIn Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level. |
| Part II: Multiple Participant Cohort (MPC) Dose Escalation | Experimental | Drug: RO7444973, Drug: TocilizumabIn Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored. |
| Part III: Recommended Phase 2 Dose (RP2D) Expansion | Experimental | Drug: RO7444973, Drug: TocilizumabBased on emerging data from Part II, an RP2D and dosing regimen will be further investigated in Part III. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Unresectable and/or metastatic solid tumors that have received standard-of-care (SOC) therapies previously and have no other SOC options available
- Confirmed HLA-A*02:01 haplotype
- Confirmed MAGE-A4 expression
- Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Life expectancy of >/=12 weeks
Key exclusion criteria (11 listed)
- History or clinical evidence of CNS primary tumors or metastases
- Another invasive malignancy in the last 2 years
- Uncontrolled hypertension
- Significant cardiovascular disease
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection
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 |
|---|---|---|
| RO7444973RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort. | Drug | Part I: Single Participant Cohort (SPC) Dose Escalation, Part II: Multiple Participant Cohort (MPC) Dose Escalation, Part III: Recommended Phase 2 Dose (RP2D) Expansion |
| TocilizumabAlso: Actemra, RoActemraTocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg. | Drug | Part I: Single Participant Cohort (SPC) Dose Escalation, Part II: Multiple Participant Cohort (MPC) Dose Escalation, Part III: Recommended Phase 2 Dose (RP2D) Expansion |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From start of treatment up to 90 days after last RO7444973 dose (up to 15 months)
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: From start of treatment up to 21-28 days
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: From baseline up to 12 months
Disease Control Rate (DCR)
Time frame: From baseline up to 12 months
Duration of Response (DoR)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 40 months)
Progression-free Survival (PFS)
Time frame: From baseline to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months)
Overall Survival (OS)
Time frame: From baseline to death from any cause (up to 40 months)
Pharmacokinetics (PK): Serum Concentration of RO7444973 Over Time
Time frame: From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months)
Change from Baseline in Percentage of Participants Positive for Anti-drug Antibodies (ADA) to RO7444973
Time frame: From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months)
Results and safety
The study was stopped early (reason given: The study was terminated due to program discontinuation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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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 RO7444973 and Tocilizumab in people with Solid Tumors, 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 12 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Aug 2023. 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 Belgium, Spain, United States, Australia, 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?
The study was stopped early (reason given: The study was terminated due to program discontinuation.). Results are not available in the source record.
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 Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From start of treatment up to 90 days after last RO7444973 dose (up to 15 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?
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 4 Aug 2023.