Refractory CancerPhase 1NCT06372574
A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors
A Phase 1 study testing RO7617991 and Tocilizumab in people with Refractory Cancer and Recurrent Cancer, run by Genentech, Inc..
Trial summary
This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult
- What is being tested?
- RO7617991 and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 1 Feb 2028
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Body weight ≥40 kilograms
- Life expectancy of at least 12 weeks
- Confirmed eligible HLA-A*02 genotype and tumor with confirmed MAGE-A4 expression
- Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies
- Measurable disease, according to RECIST v1.1
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- Adequate hematologic and end-organ function
- Resolution to Grade ≤2 of all acute, clinically significant treatment-related toxicity from prior therapy
- An archival tumor tissue specimen or fresh baseline biopsy (when archival is not available) is required
Who cannot join
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab
- Clinically significant cardiopulmonary dysfunction
- Clinically significant liver disease
- Poorly controlled Type 2 diabetes mellitus
- Active hepatitis B or C infection
- Positive test for human immunodeficiency virus (HIV)
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- History of allergic reactions to red meat or tick bites or known galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks prior to enrollment
- Active or history of autoimmune disease or immune deficiency
- Treatment with systemic immunosuppressive medications
- Prior allogeneic stem cell or solid organ transplantation
About this study
Official title: A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7617991 in HLA-A*02-Positive Patients With Locally Advanced and/or Metastatic MAGE-A4-Positive Solid Tumors
This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.
- Conditions
- Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult
- Being tested
- RO7617991, Tocilizumab
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7617991Drug
RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
TocilizumabDrug
Also called Actemra®, RoActemra®, RO4877533
Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| RO7617991 Dose Escalation and Expansion | Experimental | Not described Receives: Drug: RO7617991; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
Measured: From first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
Number of Participants with Abnormal Values in Targeted Vital Signs
The targeted vital signs include pulse rate, respiratory rate, systolic and diastolic blood pressure, pulse oximetry, and body temperature.
Measured: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters
Measured: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Secondary outcomes (6)
Serum Concentration of RO7617991 at Specific Timepoints
Measured: From first dose until 30 days after the final dose of study treatment (up to approximately 3 years)
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1
RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1
Measured: From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years)
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
Measured: From first occurrence of a confirmed objective response to disease progression or death, whichever occurs first (up to approximately 3 years)
Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1
Measured: From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years)
Overall Survival (OS)
Measured: From enrollment to death from any cause (up to approximately 3 years)
Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study
Measured: Baseline (predose) and from first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start30 Sep 2024 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Why it stopped: GO44669 study has been withdrawn due to an internal Sponsor decision. The decision was not due to any safety or efficacy concerns with the study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372574
- Sponsor's protocol ID
- GO44669
- Status last verified
- Aug 2024
- First submitted
- 15 Apr 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7617991 in HLA-A*02-Positive Patients With Locally Advanced and/or Metastatic MAGE-A4-Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT06372574
- Acronym / sponsor ID
- GO44669
- Conditions
- Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: GO44669 study has been withdrawn due to an internal Sponsor decision. The decision was not due to any safety or efficacy concerns with the study drug.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 18 Apr 2024 (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 study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RO7617991 Dose Escalation and Expansion | Experimental | Drug: RO7617991, Drug: Tocilizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Body weight ≥40 kilograms
- Life expectancy of at least 12 weeks
- Confirmed eligible HLA-A*02 genotype and tumor with confirmed MAGE-A4 expression
- Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies
Key exclusion criteria (12 listed)
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab
- Clinically significant cardiopulmonary dysfunction
- Clinically significant liver disease
- Poorly controlled Type 2 diabetes mellitus
- Active hepatitis B or C 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 |
|---|---|---|
| RO7617991RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator. | Drug | RO7617991 Dose Escalation and Expansion |
| TocilizumabAlso: Actemra®, RoActemra®, RO4877533Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol. | Drug | RO7617991 Dose Escalation and Expansion |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: From first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
Number of Participants with Abnormal Values in Targeted Vital Signs
Time frame: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
The targeted vital signs include pulse rate, respiratory rate, systolic and diastolic blood pressure, pulse oximetry, and body temperature.
Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters
Time frame: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
6 secondary outcomes
Serum Concentration of RO7617991 at Specific Timepoints
Time frame: From first dose until 30 days after the final dose of study treatment (up to approximately 3 years)
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1
Time frame: From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years)
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
Time frame: From first occurrence of a confirmed objective response to disease progression or death, whichever occurs first (up to approximately 3 years)
Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1
Time frame: From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years)
Overall Survival (OS)
Time frame: From enrollment to death from any cause (up to approximately 3 years)
Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study
Time frame: Baseline (predose) and from first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- 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
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7617991 and Tocilizumab in people with Refractory Cancer and Recurrent Cancer, run by Genentech, Inc..
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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Incidence and Severity of Adverse Events (time frame: From first dose until 90 days after the final dose of study treatment (up to approximately 3 years)). The study lists 3 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 3 Sep 2024.