NeoplasmsPhase 1NCT02004106
A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid Tumors
A Phase 1 study testing RO6895882 in people with Neoplasms, run by Hoffmann-La Roche at 10 sites in 8 countries.
Trial summary
This open-label, multi-center, dose-escalation study will evaluate the safety, pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The study will be conducted in 3 parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RO6895882
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 10 sitesin 8 countries
- Study dates
- 31 Dec 2013to 31 Aug 2016
- 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
- Participants with confirmed advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy who have progressed on the standard of care therapy
- Locally confirmed CEA expression in tumor tissue (more than [>] 20 percent (%) of tumor cells staining with at least moderate intensity) or centrally confirmed CEA expression if no archival tumor tissue and fresh biopsy is collected
- Radiologically measurable and clinically evaluable disease
- Life expectancy of greater than or equal to (>/=) 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure must have resolved to Grade </=1, except alopecia (any grade) and Grade 2 peripheral neuropathy
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- Adequate hematological, liver, and renal function
- Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women </=2 years after menopause
- Participants with Gilbert's syndrome will be eligible for the study. A diagnosis of Gilbert's syndrome will be based on the exclusion of other diseases based on the following criteria: (i) unconjugated hyperbilirubinemia noted on several occasions; (ii) no evidence of hemolysis (normal hemoglobin, reticulocyte count, and Lactate dehydrogenase); (iii) normal liver function tests; (iv) absence of other diseases associated with unconjugated hyperbilirubinemia
Who cannot join
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before screening
- Participants with an active second malignancy (other than non-melanoma skin cancer, or cervical carcinoma in situ). Participants who have a history of malignancy are not considered to have an active malignancy if they have completed therapy and are considered by their treating physician to be at less than (<) 30% risk for relapse
- Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
- Uncontrolled hypertension (systolic >150 millimeter of mercury [mmHg] and/or diastolic >100 mmHg), unstable angina, congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment
- Active or uncontrolled infections
- Known infection with human immunodeficiency virus (HIV), seropositive status
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- Positive test results for chronic hepatitis B infection (defined as positive Hepatitis B surface antigen [HBsAg] serology and/or HBcAb status)
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- Pregnant or breast-feeding women
- Known hypersensitivity to any of the components of RO6895882
- Concurrent therapy with any other investigational drug
- Regular immunosuppressive therapy (that is, for organ transplantation, chronic rheumatologic disease)
- Chronic use of steroids (including inhaled) will not be allowed. Concurrent high doses of systemic corticosteroids. High dose is considered as >20 mg of dexamethasone a day (or equivalent) for >7 consecutive days
- Radiotherapy within the last 4 weeks before start of study drug treatment with the exception of limited field palliative radiotherapy for bone pain relief
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Netherlands2 sites
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Amsterdam, 1081 HV
Spain2 sites
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035
Clinica Universitaria de Navarra; Servicio de oncología
Pamplona, Navarre, 31008
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Finland1 site
Helsinki University Central Hospital; Dept of Oncology
Helsinki, 00029
France1 site
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, 94805
United Kingdom1 site
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OX3 7LE
About this study
Official title: An Open-Label, Multi-Center, Dose-Escalation, Phase I Study With an Expansion Phase, to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6895882, an Immunocytokine, Consisting of a Variant of Interleukin-2 (IL-2v) Targeting Carcinoembryonic Antigen (CEA) Administered Intravenously, in Patients With Advanced and/or Metastatic Solid Tumors
This open-label, multi-center, dose-escalation study will evaluate the safety, pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The study will be conducted in 3 parts. Part 1 will be a single ascending dose study in single participant cohort at low RO6895882 dose (less than or equal to [</=] 6 milligrams [mg]). Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every 2 weeks (q2w), and possibly every 3 weeks (q3w). Part 3 will be an expansion phase of the qw, q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2). Part 3 will only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the investigators, is in favor of the participants. Participants will be treated until disease progression, unacceptable toxicity or withdrawal from treatment for other reasons or death for a maximum duration of 24 months.
- Conditions
- Neoplasms
- Being tested
- RO6895882
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO6895882Drug
Participants will receive RO6895882 at different dose levels and schedules defined in respective arms as IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: RO6895882 Single Ascending Dose | Experimental | Participants will receive RO6895882 at ascending doses (</= 6 mg) as a single intravenous (IV) infusion. Receives: Drug: RO6895882 |
| Part 2: RO6895882 Dose Escalation Monotherapy | Experimental | Participants in different cohorts will receive RO6895882 at ascending doses as IV infusion qw, q2w or q3w. After completion of Part 2 all participants have the option to receive the recommended RO6895882 dose once defined in Part 2 at the discretion of investigator. Receives: Drug: RO6895882 |
| Part 3: RO6895882 MTD Expansion | Experimental | Participants will receive RO6895882 at MTD determined in Part 2 as IV infusion qw, q2w or q3w. Receives: Drug: RO6895882 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 2: Percentage of Participants With Dose-Limiting Toxicity (DLT)
Measured: Part 2: within 21 days after the highest dose administration
Part 2: MTD of RO6895882
Measured: Part 2: within 21 days after the highest dose administration
Percentage of Participants With Adverse Events
Measured: Day 1 up to 28 days after last dose of study drug (up to approximately 25 months)
Percentage of Participants With Anti-drug Antibodies (ADAs) Against RO6895882
Part 1: Predose (Hour [Hr] 0). Part 2/3: qw schedule (1 cycle = 1 week): Predose in Cycle 1, 4, 5, 6, thereafter every 2 months; Part 2/3: q2w schedule (1 cycle = 2 weeks): Predose in Cycle 1, 4, 6, thereafter every 8 weeks. Part 2/3: q3w schedule (1 cycle = 3 weeks): Predose in Cycle 1, 2, 3, 4, 6, thereafter every 9 weeks. Additionally at treatment discontinuation or at 28-days after last dose (up to approximately 25 months)
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Area Under the Serum Concentration-Time Curve (AUC) of RO6895882
Predose (Hr 0), 1 hr post start of infusion (SoI), at end of infusion (EoI), 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Minimum Observed Serum Concentration (Cmin) of RO6895882
Measured: Part 1/2/3: Predose (Hr 0) in all cycles (maximum up to 25 months) (cycle length = 1, 2, or 3 weeks, respectively)
Maximum Observed Serum Concentration (Cmax) of RO6895882
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Clearance (CL) of RO6895882
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Volume of Distribution at Steady State (Vss) of RO6895882
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Half-life (t1/2) of RO6895882
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Secondary outcomes (9)
Count of Cluster of Differentiation (CD) 4+ Cells Analyzed by Flow Cytometry
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose. Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI. Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs.
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of CD8+ Cells Analyzed by Flow Cytometry
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose. Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI. Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs.
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of B Lymphocyte Cells Analyzed by Flow Cytometry
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose. Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI. Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of Natural Killer (NK) Cells Analyzed by Flow Cytometry
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose. Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI. Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of Monocytes Cells Analyzed by Flow Cytometry
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose. Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI. Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs.
Measured: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Percentage of Participants With Objective Response Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
Measured: From Screening until disease progression or death (up to approximately 25 months)
Percentage of Participants With Stable Disease Assessed According to RECIST v 1.1
Measured: From Screening until disease progression or death (up to approximately 25 months)
Percentage of Participants With Disease Control Assessed According to RECIST v 1.1
Measured: From Screening until disease progression or death (up to approximately 25 months)
Progression-Free Survival Assessed According to RECIST v 1.1
Measured: From Screening until disease progression or death (up to approximately 25 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study start31 Dec 2013
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 110 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
- NCT02004106
- Sponsor's protocol ID
- BP28920
- Other IDs
- 2013-003041-41
- Status last verified
- Mar 2018
- First submitted
- 3 Dec 2013
- Last updated
- 6 Mar 2018
- Results posted
- No
Publications
Melero I, Steeghs N, Lassen U, Homicsko K, Tabernero J, Canamero M, Roller A, Duarte J, Rossmann E, Babitzki G, Grabole N, Watson C, Habigt C, Evers S, Dejardin D, Teichgraber V, Charo J. Biomarkers of activity from a phase I study of cergutuzumab amunaleukin in patients with advanced solid tumors. J Immunother Cancer. 2026 Jan 16;14(1):e012885. doi: 10.1136/jitc-2025-012885.
PubMed 41545306
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Dose-Escalation, Phase I Study With an Expansion Phase, to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6895882, an Immunocytokine, Consisting of a Variant of Interleukin-2 (IL-2v) Targeting Carcinoembryonic Antigen (CEA) Administered Intravenously, in Patients With Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02004106
- Acronym / sponsor ID
- BP28920
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2013 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 6 Dec 2013 (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 open-label, multi-center, dose-escalation study will evaluate the safety, pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The study will be conducted in 3 parts. Part 1 will be a single ascending dose study in single participant cohort at low RO6895882 dose (less than or equal to [</=] 6 milligrams [mg]). Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every 2 weeks (q2w), and possibly every 3 weeks (q3w). Part 3 will be an expansion phase of the qw, q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2). Part 3 will only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the investigators, is in favor of the participants. Participants will be treated until disease progression, unacceptable toxicity or withdrawal from treatment for other reasons or death for a maximum duration of 24 months.
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: RO6895882 Single Ascending Dose | Experimental | Drug: RO6895882Participants will receive RO6895882 at ascending doses (</= 6 mg) as a single intravenous (IV) infusion. |
| Part 2: RO6895882 Dose Escalation Monotherapy | Experimental | Drug: RO6895882Participants in different cohorts will receive RO6895882 at ascending doses as IV infusion qw, q2w or q3w. After completion of Part 2 all participants have the option to receive the recommended RO6895882 dose once defined in Part 2 at the discretion of investigator. |
| Part 3: RO6895882 MTD Expansion | Experimental | Drug: RO6895882Participants will receive RO6895882 at MTD determined in Part 2 as IV infusion qw, q2w or q3w. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants with confirmed advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy who have progressed on the standard of care therapy
- Locally confirmed CEA expression in tumor tissue (more than [>] 20 percent (%) of tumor cells staining with at least moderate intensity) or centrally confirmed CEA expression if no archival tumor tissue and fresh biopsy is collected
- Radiologically measurable and clinically evaluable disease
- Life expectancy of greater than or equal to (>/=) 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Key exclusion criteria (15 listed)
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before screening
- Participants with an active second malignancy (other than non-melanoma skin cancer, or cervical carcinoma in situ). Participants who have a history of malignancy are not considered to have an active malignancy if they have completed therapy and are considered by their treating physician to be at less than (<) 30% risk for relapse
- Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
- Uncontrolled hypertension (systolic >150 millimeter of mercury [mmHg] and/or diastolic >100 mmHg), unstable angina, congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment
- Active or uncontrolled infections
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 |
|---|---|---|
| RO6895882Participants will receive RO6895882 at different dose levels and schedules defined in respective arms as IV infusion. | Drug | Part 1: RO6895882 Single Ascending Dose, Part 2: RO6895882 Dose Escalation Monotherapy, Part 3: RO6895882 MTD Expansion |
Primary outcome
Part 2: Percentage of Participants With Dose-Limiting Toxicity (DLT)
Time frame: Part 2: within 21 days after the highest dose administration
Part 2: MTD of RO6895882
Time frame: Part 2: within 21 days after the highest dose administration
Percentage of Participants With Adverse Events
Time frame: Day 1 up to 28 days after last dose of study drug (up to approximately 25 months)
Percentage of Participants With Anti-drug Antibodies (ADAs) Against RO6895882
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Part 1: Predose (Hour [Hr] 0). Part 2/3: qw schedule (1 cycle = 1 week): Predose in Cycle 1, 4, 5, 6, thereafter every 2 months; Part 2/3: q2w schedule (1 cycle = 2 weeks): Predose in Cycle 1, 4, 6, thereafter every 8 weeks. Part 2/3: q3w schedule (1 cycle = 3 weeks): Predose in Cycle 1, 2, 3, 4, 6, thereafter every 9 weeks. Additionally at treatment discontinuation or at 28-days after last dose (up to approximately 25 months)
Area Under the Serum Concentration-Time Curve (AUC) of RO6895882
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Predose (Hr 0), 1 hr post start of infusion (SoI), at end of infusion (EoI), 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Minimum Observed Serum Concentration (Cmin) of RO6895882
Time frame: Part 1/2/3: Predose (Hr 0) in all cycles (maximum up to 25 months) (cycle length = 1, 2, or 3 weeks, respectively)
Maximum Observed Serum Concentration (Cmax) of RO6895882
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Clearance (CL) of RO6895882
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Volume of Distribution at Steady State (Vss) of RO6895882
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
Half-life (t1/2) of RO6895882
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.
9 secondary outcomes
Count of Cluster of Differentiation (CD) 4+ Cells Analyzed by Flow Cytometry
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of CD8+ Cells Analyzed by Flow Cytometry
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of B Lymphocyte Cells Analyzed by Flow Cytometry
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of Natural Killer (NK) Cells Analyzed by Flow Cytometry
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of Monocytes Cells Analyzed by Flow Cytometry
Time frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Percentage of Participants With Objective Response Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
Time frame: From Screening until disease progression or death (up to approximately 25 months)
Percentage of Participants With Stable Disease Assessed According to RECIST v 1.1
Time frame: From Screening until disease progression or death (up to approximately 25 months)
Percentage of Participants With Disease Control Assessed According to RECIST v 1.1
Time frame: From Screening until disease progression or death (up to approximately 25 months)
Progression-Free Survival Assessed According to RECIST v 1.1
Time frame: From Screening until disease progression or death (up to approximately 25 months)
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 6 Mar 2018.
- Derived from this study: PubMed 41545306Melero I, Steeghs N, Lassen U, Homicsko K, Tabernero J, Canamero M, Roller A, Duarte J, Rossmann E, Babitzki G, Grabole N, Watson C, Habigt C, Evers S, Dejardin D, Teichgraber V, Charo J. Biomarkers of activity from a phase I study of cergutuzumab amunaleukin in patients with advanced solid tumors. J Immunother Cancer. 2026 Jan 16;14(1):e012885. doi: 10.1136/jitc-2025-012885.
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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 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO6895882 in people with Neoplasms, run by Hoffmann-La Roche at 10 sites in 8 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 15 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 6 Mar 2018. 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 Netherlands, Spain, United States, Denmark, Finland and 3 more countries. 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 2: Percentage of Participants With Dose-Limiting Toxicity (DLT) (time frame: Part 2: within 21 days after the highest dose administration). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.