Solid TumorsPhase 1NCT04158583
A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumors
A Phase 1 study testing RO7296682 in people with Solid Tumors, run by Hoffmann-La Roche at 11 sites in 5 countries.
Trial summary
This study was planned to evaluate the safety and tolerability of RO7296682 in participants with advanced solid tumors. 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?
- RO7296682
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 9 Dec 2019to 21 Jul 2022
- 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
- Diagnosis of advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC. Participants whose tumors have known sensitizing mutation must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.
- Measurable disease according to response evaluation criteria in solid tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Able to provide the most recent archival tumor tissue samples.
- Adequate cardiovascular, haematological, liver and renal function.
- Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.
- Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
- Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.
Who cannot join
- Pregnancy, lactation, or breastfeeding.
- Known hypersensitivity to any of the components of RO7296682, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
- Participants with another invasive malignancy in the last two years.
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
- Participants with known active or uncontrolled infection.
Show all 18Show fewer
- Positive human immunodeficiency virus (HIV) test at screening.
- Positive for Hepatitis B and C.
- Vaccination with live vaccines within 28 days prior to C1D1.
- Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 infusion.
- Participants with wound healing complications.
- Dementia or altered mental status that would prohibit informed consent.
- History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).
- Active or history of autoimmune disease or immune deficiency.
- Prior treatment with checkpoint inhibitors (CPIs) (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.
- Prior treatment with a CC chemokine receptor 4 (CCR4)-targeting (e.g. mogamulizumab) or a CD25-targeting agent (e.g. basiliximab) is prohibited.
- Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.
- Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Spain5 sites
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
Canada3 sites
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K2H 6C2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
BC Cancer Agency - Vancouver
Vancouver, British Columbia, V5Z 4E6
Australia1 site
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria, 3000
About this study
Official title: An Open-Label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7296682, A CD25-Targeting, T-Regulatory Cell Depleting Antibody in Participants With Advanced and/or Metastatic Solid Tumor
This study was planned to evaluate the safety and tolerability of RO7296682 in participants with advanced solid tumors.
Read the detailed description
A Phase 1, open-label, dose-escalation study designed to evaluate the safety and tolerability of RO7296682 in participants with advanced and/or metastatic solid tumors. RO7296682 was administered by IV infusion Q3W. This entry-into-human study is divided into a dose-escalation stage (Part A) and a dose expansion stage (Part B).
- Conditions
- Solid Tumors
- Being tested
- RO7296682
- Keywords
- RG6292
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7296682Drug
RO7296682 will be administered by the schedules specified in the respective arms.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1 RO7296682 0.3 mg Q3W | Experimental | Participants with non-small cell lung cancer (NSCLC), melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), ovarian cancer (OvC), triple-negative breast cancer (TNBC), and esophageal carcinoma (EsC) received RO7296682 0.3 milligram (mg) intravenous (IV) infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, every 3 weeks (Q3W). Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 2 RO7296682 1 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 3 RO7296682 2 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 4 RO7296682 6 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 5 RO7296682 18 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 6 RO7296682 35 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 7 RO7296682 70 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 8 RO7296682 100 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 9 RO7296682 165 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
| Part A: Cohort 10 RO7296682 20 mg Q3W | Experimental | Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. Receives: Drug: RO7296682 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AE) Determined According to The National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: From signing of informed consent form (ICF) until last follow-up visit (Up to approximately 2 years 7 months)
Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as occurrence of a clinically significant adverse event (AE) from first administration of RO7296682 up to 7 days after second administration of RO7296682. DLTs were defined as following: 1) Hematologic toxicities - Grade 4 neutropenia lasting >=7 days, Grade >=3 febrile neutropenia, Grade 4 thrombocytopenia lasting >=48 hours, Grade 3 thrombocytopenia associated with bleeding episode and Grade 4 anemia 2) Nonhematologic toxicities - Grade 3 nausea, vomiting or diarrhea, Grade >=3 fatigue, Grade 3 arthralgia, fever >40 degree Celsius occurs within 48 hours, Grade >+ laboratory abnormalities, Grade 3 autoimmune thyroiditis or other endocrine abnormalities, Grade 3 tumor flare, Grade 3 transient increase of bilirubin in participants with liver lesions, transaminases (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) and/or gamma-glutamyl transferase (GGT) and any other RO7296682-related toxicity significant enough to be qualified as DLT.
Measured: Up to 28 days
Secondary outcomes (14)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigators' assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters in the absence of CR.
Measured: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months )
Disease Control Rate (DCR)
DCR defined as the percentage of participants with an overall response of either CR, PR, or stable disease (SD), based on Investigators' assessment using RECIST Version 1.1. CR is defined as disappearance of all target lesions. any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PD is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir).
Measured: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)
Duration of Response (DOR)
DOR is defined as the time from first occurrence of a documented objective response to disease progression as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. Objective response is defined as the percentage of participants having a CR or PR as determined by investigators' assessment of radiographic disease per RECIST v1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters in the absence of CR.
Measured: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)
On-Treatment Progression Free Survival (PFS)
The PFS on treatment was defined as the time from study treatment initiation (Cycle 1 Day 1, (1 cycle=21 days) ) to the first occurrence of documented disease progression based on RECIST Version 1.1 Investigator's assessment, or death from any cause, whichever occurred first. For participants who did not have documented progressive disease or death (within 30 days from last study treatment) during the study, PFS was censored at the day of the last tumor assessment. Participants without any post baseline assessments or with all post-baseline assessments having unknown result/response but known to be alive at the clinical cut off for the analysis would be censored at the date of study treatment initiation plus one day.
Measured: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)
Area Under the Serum Concentration Time Curve (AUC) of RO7296682
Measured: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Minimum Serum Concentration (Cmin) of RO7296682
Measured: Cycles 3 or 4 (Cycle length = 21 days)
Maximum Serum Concentration (Cmax) of RO7296682
Measured: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Total Clearance (CL) of RO7296682
Measured: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Volume of Distribution at Steady State (Vss) of RO7296682
Measured: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Terminal Half-Life (T1/2) of RO7296682
Measured: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Time of Maximum Concentration (Tmax) of RO7296682
Measured: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Number of Participants With Anti-Drug Antibodies (ADA) During the Study Relative to the Prevalence of ADA at Baseline
Measured: Predose on Day 1 of each 21-day and subsequent cycles up to end of study (Up to approximately 2 years 7 months)
Treatment-induced Changes in Treg Levels in Blood and/or Tumor as Compared to Baseline
Measured: Baseline and at Cycle 1 Day 4 (Cycle length = 21 days)
Treatment-induced Changes in Treg/Teff (T-regulatory Cell; T-effector Cell) Ratio in Blood and/or Tumor as Compared to Baseline
Measured: Baseline and at Cycle 1 Day 4 (Cycle length = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start9 Dec 2019
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Why it stopped: Halted in order to focus on the ongoing combination of RO7296682 with Atezolizumab, evaluated in study BP42595, as a higher likelihood for efficacy is expected in combination with Atezolizumab as compared to the monotherapy setting.
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 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
- NCT04158583
- Sponsor's protocol ID
- WP41188
- Other IDs
- 2019-002830-35, RG6292, 2019
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2019
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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/members/ourmembers/). 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7296682, A CD25-Targeting, T-Regulatory Cell Depleting Antibody in Participants With Advanced and/or Metastatic Solid Tumor
- ClinicalTrials.gov ID
- NCT04158583
- Acronym / sponsor ID
- WP41188
- Conditions
- Solid Tumors
- Keywords
- RG6292
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted in order to focus on the ongoing combination of RO7296682 with Atezolizumab, evaluated in study BP42595, as a higher likelihood for efficacy is expected in combination with Atezolizumab as compared to the monotherapy setting.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was planned to evaluate the safety and tolerability of RO7296682 in participants with advanced solid tumors.
Detailed description
A Phase 1, open-label, dose-escalation study designed to evaluate the safety and tolerability of RO7296682 in participants with advanced and/or metastatic solid tumors. RO7296682 was administered by IV infusion Q3W. This entry-into-human study is divided into a dose-escalation stage (Part A) and a dose expansion stage (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1 RO7296682 0.3 mg Q3W | Experimental | Drug: RO7296682Participants with non-small cell lung cancer (NSCLC), melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), ovarian cancer (OvC), triple-negative breast cancer (TNBC), and esophageal carcinoma (EsC) received RO7296682 0.3 milligram (mg) intravenous (IV) infusion on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, every 3 weeks (Q3W). Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 2 RO7296682 1 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 1 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 3 RO7296682 2 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 2 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 4 RO7296682 6 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 6 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 5 RO7296682 18 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 18 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 6 RO7296682 35 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 35 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 7 RO7296682 70 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 70 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 8 RO7296682 100 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 100 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 9 RO7296682 165 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 165 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
| Part A: Cohort 10 RO7296682 20 mg Q3W | Experimental | Drug: RO7296682Participants with NSCLC, MEL, HNSCC, OvC, TNBC, and EsC received RO7296682 20 mg, IV infusion, on Day 1 of Cycle 1 (1 cycle=21 days), and at subsequent cycles, Q3W. Participants experiencing toxicities fulfilling the definition of a DLT (e.g: skin toxicities; Grade >=4, IRR; Grade >=4, immune-mediated adverse events; Grade >=4) were discontinued from study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC. Participants whose tumors have known sensitizing mutation must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.
- Measurable disease according to response evaluation criteria in solid tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Able to provide the most recent archival tumor tissue samples.
- Adequate cardiovascular, haematological, liver and renal function.
Key exclusion criteria (18 listed)
- Pregnancy, lactation, or breastfeeding.
- Known hypersensitivity to any of the components of RO7296682, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
- Participants with another invasive malignancy in the last two years.
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
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 |
|---|---|---|
| RO7296682RO7296682 will be administered by the schedules specified in the respective arms. | Drug | Part A: Cohort 1 RO7296682 0.3 mg Q3W, Part A: Cohort 10 RO7296682 20 mg Q3W, Part A: Cohort 2 RO7296682 1 mg Q3W, Part A: Cohort 3 RO7296682 2 mg Q3W, Part A: Cohort 4 RO7296682 6 mg Q3W, Part A: Cohort 5 RO7296682 18 mg Q3W, Part A: Cohort 6 RO7296682 35 mg Q3W, Part A: Cohort 7 RO7296682 70 mg Q3W, Part A: Cohort 8 RO7296682 100 mg Q3W, Part A: Cohort 9 RO7296682 165 mg Q3W |
Primary outcome
Number of Participants With Adverse Events (AE) Determined According to The National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)
Time frame: From signing of informed consent form (ICF) until last follow-up visit (Up to approximately 2 years 7 months)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
A DLT was defined as occurrence of a clinically significant adverse event (AE) from first administration of RO7296682 up to 7 days after second administration of RO7296682. DLTs were defined as following: 1) Hematologic toxicities - Grade 4 neutropenia lasting >=7 days, Grade >=3 febrile neutropenia, Grade 4 thrombocytopenia lasting >=48 hours, Grade 3 thrombocytopenia associated with bleeding episode and Grade 4 anemia 2) Nonhematologic toxicities - Grade 3 nausea, vomiting or diarrhea, Grade >=3 fatigue, Grade 3 arthralgia, fever >40 degree Celsius occurs within 48 hours, Grade >+ laboratory abnormalities, Grade 3 autoimmune thyroiditis or other endocrine abnormalities, Grade 3 tumor flare, Grade 3 transient increase of bilirubin in participants with liver lesions, transaminases (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) and/or gamma-glutamyl transferase (GGT) and any other RO7296682-related toxicity significant enough to be qualified as DLT.
14 secondary outcomes
Objective Response Rate (ORR)
Time frame: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months )
Disease Control Rate (DCR)
Time frame: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)
Duration of Response (DOR)
Time frame: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)
On-Treatment Progression Free Survival (PFS)
Time frame: From treatment initiation until last follow-up visit (Up to approximately 2 years 7 months)
Area Under the Serum Concentration Time Curve (AUC) of RO7296682
Time frame: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Minimum Serum Concentration (Cmin) of RO7296682
Time frame: Cycles 3 or 4 (Cycle length = 21 days)
Maximum Serum Concentration (Cmax) of RO7296682
Time frame: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Total Clearance (CL) of RO7296682
Time frame: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Volume of Distribution at Steady State (Vss) of RO7296682
Time frame: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Terminal Half-Life (T1/2) of RO7296682
Time frame: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Time of Maximum Concentration (Tmax) of RO7296682
Time frame: Cycles 1, and 3 or 4 (Cycle length = 21 days)
Number of Participants With Anti-Drug Antibodies (ADA) During the Study Relative to the Prevalence of ADA at Baseline
Time frame: Predose on Day 1 of each 21-day and subsequent cycles up to end of study (Up to approximately 2 years 7 months)
Treatment-induced Changes in Treg Levels in Blood and/or Tumor as Compared to Baseline
Time frame: Baseline and at Cycle 1 Day 4 (Cycle length = 21 days)
Treatment-induced Changes in Treg/Teff (T-regulatory Cell; T-effector Cell) Ratio in Blood and/or Tumor as Compared to Baseline
Time frame: Baseline and at Cycle 1 Day 4 (Cycle length = 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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/members/ourmembers/). 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
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7296682 in people with Solid Tumors, run by Hoffmann-La Roche at 11 sites in 5 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 8 inclusion and 18 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Canada, Australia, Belgium, Denmark. 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 4 Mar 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 Adverse Events (AE) Determined According to The National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0) (time frame: From signing of informed consent form (ICF) until last follow-up visit (Up to approximately 2 years 7 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 Mar 2024.