NeoplasmsPhase 1NCT02558140
A Dose Escalation Study of RO6874813 in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing RO6874813 in people with Neoplasms, run by Hoffmann-La Roche at 4 sites in 3 countries.
Trial summary
This first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RO6874813
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 11 Oct 2015to 6 Nov 2017
- 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
- Part 1: Participants with histologically/cytologically confirmed locally advanced or metastatic, non-resectable solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists
- Part 2: Participants with histologically/ cytologically confirmed locally advanced or metastatic, non-resectable solid tumors known to be FAP+ whose disease has progressed despite standard therapy or for whom no standard therapy exists
- Part 3: Participants with histologically confirmed recurrent or metastatic, non-resectable confirmed FAP+ sarcoma with two or fewer prior regimens for advanced disease
- All participants must have tumor tissue that can be imaged for pharmacodynamic assessments and from which a pre- and on-treatment biopsy can be safely obtained
- An archival tumor sample must be available for retrospective FAP expression analysis
- Measurable disease as determined by RECIST v1.1
Show all 9Show fewer
- World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
- Recovery from all reversible AEs of previous anti-cancer therapies to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade 1, except for alopecia (any grade) and Grade <=2 sensory peripheral neuropathy
- Negative pregnancy test
Who cannot join
- Primary central nervous (CNS) tumors or CNS tumor involvement
- Major surgery or any other prior anti-cancer treatment within 4 weeks prior to study Day 1.
- Received wide-field radiotherapy <= 4 weeks or limited-field radiotherapy <=2 weeks prior to starting study drug
- Known hypersensitivity to any of the components of RO6874813 or to the contrast agents used in the study
- Another invasive malignancy in the last 2 years except for those with a minimal risk of metastasis or death
- Any other conditions or diseases that would contraindicate participation in the clinical study because of safety concerns or compliance with clinical study procedures
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, 28050
About this study
Official title: An Open-Label, Multicenter, Dose-Escalation Phase I Study of RO6874813, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
This first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of RO6874813 will continue to be characterized in participants with locally advanced and/or metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.
- Conditions
- Neoplasms
- Being tested
- RO6874813
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO6874813Biological
RO6874813 will be administered at a single low dose of 0.5 mg/kg via IV infusion in a 7- day PK run-in period (Cycle 0). Dose level for RO6874813 will be escalated to determine MTD and RP2D for RO6874813.
RO6874813Biological
RO6874813 at RP2D will be administered by IV infusion as per dosing schedule determined in Part 1.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | All participants will be given RO6874813 as a single low dose of 0.5 milligrams per kilogram (mg/kg) via intravenous (IV) infusion in a 7-day pharmacokinetic (PK) run-in period (Cycle 0). This is followed by dose escalation (Cycle 1) for which participants will receive escalating doses of RO6874813 (starting dose = 1 mg/kg) via IV infusion every week (qw) or every 2 weeks (Q2W) for 28 to 42 days to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Receives: Biological: RO6874813 |
| Part 2: Tumor Biopsy and Imaging | Experimental | The first 15 participants with fibroblast activation protein-alpha positive (FAP+) tumors will be treated at the RP2D and dosing schedule as determined in Part 1, and will undergo paired tumor biopsies for biomarker assessments. Up to 5 participants with FAP+ tumors will undergo baseline and on-treatment tumor biopsies for biomarker assessments at a dose below the RP2D. The dose for these participants can be escalated to RP2D after 4 weeks of treatment and upon completion of biomarker assessment. Receives: Biological: RO6874813 |
| Part 3: Preliminary Efficacy Assessment | Experimental | Participants with locally advanced or metastatic non-resectable FAP+ sarcoma will be treated with RO6874813 at the RP2D and as per schedule determined upon completion of Part 1. Participants continuing treatment with RO6874813 beyond 36 weeks will enter the extension phase of Part 3 and will be monitored for disease status and clinical safety per routine standard of care. Receives: Biological: RO6874813 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Percentage of Participants With Dose-Limiting Toxicity (DLT)
Measured: 28 days
Part 1: Maximum Tolerated Dose (MTD) of RO6874813
Measured: 28 days
Part 1: Recommended Phase 2 Dose (RP2D) of RO6874813
Measured: 28 days
Parts 1 and 2: Percentage of Participants With Adverse Events (AEs)
Measured: Baseline up to approximately 24 months
Parts 1 and 2: Percentage of Participants With Anti-Drug Antibodies (ADAs)
Q2W (1 cycle=14 days): Predose (Hr 0) on Day 1 of Run-in period (Part 1 only), Cycles 1, 3, 5, then every 2 cycles (up to approximately 12 months); QW (1 cycle=7 days): Predose on Day 1 of Run-in period (Part 1 only), Cycles 1, 2, 5, then every 2 cycles (up to approximately 12 months)
Measured: Predose (Hour [Hr] 0) on Day 1 up to approximately 12 months; please see outcome measure description for detailed time frame
Part 3: Percentage of Participants With Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: Baseline until disease progression (up to approximately 12 months)
Part 3: Percentage of Participants With Disease Control as Determined by the Investigator Using RECIST v1.1
Measured: Baseline up to approximately 12 months
Part 3: Duration of Response (DoR) as Determined by the Investigator Using RECIST v1.1
Measured: Baseline up to approximately 12 months
Part 3: Median Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1
Measured: Baseline up to approximately 12 months
Part 3: Percentage of Participants Who are Progression-Free at Months 3 as Determined by the Investigator Using RECIST v1.1
Measured: Month 3
Part 3: Percentage of Participants Who are Progression-Free at Month 6 as Determined by the Investigator Using RECIST v1.1
Measured: Month 6
Part 3: Median Overall Survival (OS)
Measured: Baseline until death (up to approximately 24 months)
Part 3: Percentage of Participants Who are Alive at Month 12
Measured: Month 12
Secondary outcomes (18)
Parts 1, 2, and 3: Maximum Observed Serum Concentration (Cmax) of RO6874813
Run-in Period (Part 1 only): Predose (Hr 0), End of Infusion (EoI) (infusion length less than or equal to [<=] 1.5 hrs), 24, 48, 72 (only for QW), and 96 hrs after EoI. Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose and EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months). QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose, EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months)
Measured: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Minimum Observed Serum Concentration (Cmin) of RO6874813
Measured: QW or Q2W: Predose (Hr 0) on Day 1 in Cycles 0, 1, 2, 3, 4, 5, 6, 7, and every 2 cycles thereafter (up to approximately 12 months)
Parts 1, 2, and 3: Time to Reach Cmax (Tmax) of RO6874813
Run-in Period (Part 1 only): Predose (Hr 0), EoI (infusion length <=1.5 hrs), 24, 48, 72 (only for QW), and 96 hrs after EoI. Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose and EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months). QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose, EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months)
Measured: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Half-Life (t1/2) of RO6874813
Run-in Period (Part 1 only): Predose (Hr 0), EoI (infusion length <=1.5 hrs), 24, 48, 72 (only for QW), and 96 hrs after EoI. Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose and EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months). QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose, EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months)
Measured: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Area Under the Concentration-Time Curve (AUC) of RO6874813
Run-in Period (Part 1 only): Predose (Hr 0), EoI (infusion length <=1.5 hrs), 24, 48, 72 (only for QW), and 96 hrs after EoI. Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose and EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months). QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose, EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months)
Measured: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Clearance (CL) of RO6874813
Run-in Period (Part 1 only): Predose (Hr 0), EoI (infusion length <=1.5 hrs), 24, 48, 72 (only for QW), and 96 hrs after EoI. Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose and EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months). QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose, EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months)
Measured: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: AUC During One Dose Interval (AUCtau) of RO6874813
Measured: Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycle 1 and QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycle 1
Parts 1, 2, and 3: Volume at Steady State (Vss) of RO6874813
Run-in Period (Part 1 only): Predose (Hr 0), EoI (infusion length <=1.5 hrs), 24, 48, 72 (only for QW), and 96 hrs after EoI. Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose and EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months). QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose, EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months)
Measured: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Accumulation Ratio (RA) of RO6874813
Run-in Period (Part 1 only): Predose (Hr 0), EoI (infusion length <=1.5 hrs), 24, 48, 72 (only for QW), and 96 hrs after EoI. Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose and EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months). QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycles 1 and 4; Predose, EoI, and 2 hrs after EoI in Cycles 2 and 6; Predose, EoI in Cycles 3, 5, 7, and every 2 cycles thereafter (up to approximately 12 months)
Measured: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Observed Steady-State Concentration at the End of a Dosing Interval (Ctrough) of RO6874813
Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycle 1. QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycle 1
Measured: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Change from Baseline in Body Weight Corrected Maximum Standardized Uptake Volume (SUVmax) as Measured by 2-[18F]Fluoro-2-Deoxyglucose Positron Emission Tomography ([18F]-FDG PET)
Measured: Baseline and 12 months
Part 1 and 2: Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1
Measured: Baseline up to approximately 12 months
Part 1 and 2: Percentage of Participants With Disease Control as Determined by the Investigator Using RECIST v1.1
Measured: Baseline up to approximately 12 months
Part 1 and 2: DOR as Determined by the Investigator Using RECIST v1.1
Measured: Baseline up to approximately 12 months
Part 1 and 2: Median PFS as Determined by the Investigator Using RECIST v1.1
Measured: Baseline up to approximately 12 months
Part 1 and 2: Percentage of Participants Who are Progression-Free at Month 6 as Determined by the Investigator Using RECIST v1.1
Measured: Month 6
Part 3: Percentage of Participants With AEs
Measured: Baseline up to approximately 24 months
Part 3: Percentage of Participants With ADAs
Q2W (1 cycle=14 days): Predose (Hr 0) on Day 1 of Run-in period (Part 1 only), Cycles 1, 3, 5, then every 2 cycles (up to approximately 12 months); QW (1 cycle=7 days): Predose on Day 1 of Run-in period (Part 1 only), Cycles 1, 2, 5, then every 2 cycles (up to approximately 12 months)
Measured: Predose (Hr 0) on Day 1 up to approximately 12 months; please see outcome measure description for detailed time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study start11 Oct 2015
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 120 participants (estimated)
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
- NCT02558140
- Sponsor's protocol ID
- BP29773
- Other IDs
- RG7386, 2015-001889-26, 2015
- Status last verified
- Apr 2018
- First submitted
- 15 Sep 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Dose-Escalation Phase I Study of RO6874813, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02558140
- Acronym / sponsor ID
- BP29773
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2015 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 23 Sep 2015 (estimated)
- 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 first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of RO6874813 will continue to be characterized in participants with locally advanced and/or metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Biological: RO6874813All participants will be given RO6874813 as a single low dose of 0.5 milligrams per kilogram (mg/kg) via intravenous (IV) infusion in a 7-day pharmacokinetic (PK) run-in period (Cycle 0). This is followed by dose escalation (Cycle 1) for which participants will receive escalating doses of RO6874813 (starting dose = 1 mg/kg) via IV infusion every week (qw) or every 2 weeks (Q2W) for 28 to 42 days to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). |
| Part 2: Tumor Biopsy and Imaging | Experimental | Biological: RO6874813The first 15 participants with fibroblast activation protein-alpha positive (FAP+) tumors will be treated at the RP2D and dosing schedule as determined in Part 1, and will undergo paired tumor biopsies for biomarker assessments. Up to 5 participants with FAP+ tumors will undergo baseline and on-treatment tumor biopsies for biomarker assessments at a dose below the RP2D. The dose for these participants can be escalated to RP2D after 4 weeks of treatment and upon completion of biomarker assessment. |
| Part 3: Preliminary Efficacy Assessment | Experimental | Biological: RO6874813Participants with locally advanced or metastatic non-resectable FAP+ sarcoma will be treated with RO6874813 at the RP2D and as per schedule determined upon completion of Part 1. Participants continuing treatment with RO6874813 beyond 36 weeks will enter the extension phase of Part 3 and will be monitored for disease status and clinical safety per routine standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Part 1: Participants with histologically/cytologically confirmed locally advanced or metastatic, non-resectable solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists
- Part 2: Participants with histologically/ cytologically confirmed locally advanced or metastatic, non-resectable solid tumors known to be FAP+ whose disease has progressed despite standard therapy or for whom no standard therapy exists
- Part 3: Participants with histologically confirmed recurrent or metastatic, non-resectable confirmed FAP+ sarcoma with two or fewer prior regimens for advanced disease
- All participants must have tumor tissue that can be imaged for pharmacodynamic assessments and from which a pre- and on-treatment biopsy can be safely obtained
- An archival tumor sample must be available for retrospective FAP expression analysis
Key exclusion criteria (6 listed)
- Primary central nervous (CNS) tumors or CNS tumor involvement
- Major surgery or any other prior anti-cancer treatment within 4 weeks prior to study Day 1.
- Received wide-field radiotherapy <= 4 weeks or limited-field radiotherapy <=2 weeks prior to starting study drug
- Known hypersensitivity to any of the components of RO6874813 or to the contrast agents used in the study
- Another invasive malignancy in the last 2 years except for those with a minimal risk of metastasis or death
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 |
|---|---|---|
| RO6874813RO6874813 will be administered at a single low dose of 0.5 mg/kg via IV infusion in a 7- day PK run-in period (Cycle 0). Dose level for RO6874813 will be escalated to determine MTD and RP2D for RO6874813. | Biological | Part 1: Dose Escalation |
| RO6874813RO6874813 at RP2D will be administered by IV infusion as per dosing schedule determined in Part 1. | Biological | Part 2: Tumor Biopsy and Imaging, Part 3: Preliminary Efficacy Assessment |
Primary outcome
Part 1: Percentage of Participants With Dose-Limiting Toxicity (DLT)
Time frame: 28 days
Part 1: Maximum Tolerated Dose (MTD) of RO6874813
Time frame: 28 days
Part 1: Recommended Phase 2 Dose (RP2D) of RO6874813
Time frame: 28 days
Parts 1 and 2: Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to approximately 24 months
Parts 1 and 2: Percentage of Participants With Anti-Drug Antibodies (ADAs)
Time frame: Predose (Hour [Hr] 0) on Day 1 up to approximately 12 months; please see outcome measure description for detailed time frame
Q2W (1 cycle=14 days): Predose (Hr 0) on Day 1 of Run-in period (Part 1 only), Cycles 1, 3, 5, then every 2 cycles (up to approximately 12 months); QW (1 cycle=7 days): Predose on Day 1 of Run-in period (Part 1 only), Cycles 1, 2, 5, then every 2 cycles (up to approximately 12 months)
Part 3: Percentage of Participants With Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Baseline until disease progression (up to approximately 12 months)
Part 3: Percentage of Participants With Disease Control as Determined by the Investigator Using RECIST v1.1
Time frame: Baseline up to approximately 12 months
Part 3: Duration of Response (DoR) as Determined by the Investigator Using RECIST v1.1
Time frame: Baseline up to approximately 12 months
Part 3: Median Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1
Time frame: Baseline up to approximately 12 months
Part 3: Percentage of Participants Who are Progression-Free at Months 3 as Determined by the Investigator Using RECIST v1.1
Time frame: Month 3
Part 3: Percentage of Participants Who are Progression-Free at Month 6 as Determined by the Investigator Using RECIST v1.1
Time frame: Month 6
Part 3: Median Overall Survival (OS)
Time frame: Baseline until death (up to approximately 24 months)
Part 3: Percentage of Participants Who are Alive at Month 12
Time frame: Month 12
18 secondary outcomes
Parts 1, 2, and 3: Maximum Observed Serum Concentration (Cmax) of RO6874813
Time frame: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Minimum Observed Serum Concentration (Cmin) of RO6874813
Time frame: QW or Q2W: Predose (Hr 0) on Day 1 in Cycles 0, 1, 2, 3, 4, 5, 6, 7, and every 2 cycles thereafter (up to approximately 12 months)
Parts 1, 2, and 3: Time to Reach Cmax (Tmax) of RO6874813
Time frame: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Half-Life (t1/2) of RO6874813
Time frame: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Area Under the Concentration-Time Curve (AUC) of RO6874813
Time frame: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Clearance (CL) of RO6874813
Time frame: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: AUC During One Dose Interval (AUCtau) of RO6874813
Time frame: Q2W (1 cycle=14 days): Predose, EoI, 2, 6, 24, 72, 96, 168, and 240 hrs after EoI in Cycle 1 and QW (1 cycle=7 days): Predose, EoI, 2, 6, 24, 48, 72, and 96 hrs after EoI in Cycle 1
Parts 1, 2, and 3: Volume at Steady State (Vss) of RO6874813
Time frame: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Accumulation Ratio (RA) of RO6874813
Time frame: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Observed Steady-State Concentration at the End of a Dosing Interval (Ctrough) of RO6874813
Time frame: Predose (Hr 0) up to approximately 12 months; please see outcome measure description for detailed time frame
Parts 1, 2, and 3: Change from Baseline in Body Weight Corrected Maximum Standardized Uptake Volume (SUVmax) as Measured by 2-[18F]Fluoro-2-Deoxyglucose Positron Emission Tomography ([18F]-FDG PET)
Time frame: Baseline and 12 months
Part 1 and 2: Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1
Time frame: Baseline up to approximately 12 months
Part 1 and 2: Percentage of Participants With Disease Control as Determined by the Investigator Using RECIST v1.1
Time frame: Baseline up to approximately 12 months
Part 1 and 2: DOR as Determined by the Investigator Using RECIST v1.1
Time frame: Baseline up to approximately 12 months
Part 1 and 2: Median PFS as Determined by the Investigator Using RECIST v1.1
Time frame: Baseline up to approximately 12 months
Part 1 and 2: Percentage of Participants Who are Progression-Free at Month 6 as Determined by the Investigator Using RECIST v1.1
Time frame: Month 6
Part 3: Percentage of Participants With AEs
Time frame: Baseline up to approximately 24 months
Part 3: Percentage of Participants With ADAs
Time frame: Predose (Hr 0) on Day 1 up to approximately 12 months; please see outcome measure description for detailed time frame
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO6874813 in people with Neoplasms, run by Hoffmann-La Roche at 4 sites in 3 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 9 inclusion and 6 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 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, United States, France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1: Percentage of Participants With Dose-Limiting Toxicity (DLT) (time frame: 28 days). The study lists 13 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 Apr 2018.