Metastatic Colorectal CancerPhase 1NCT03035253
A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer
A Phase 1 study testing OMP-305B83, FOLFIRI and FOLFOX in people with Metastatic Colorectal Cancer, run by OncoMed Pharmaceuticals, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific monoclonal antibody and was developed to target cancer stem cells. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- OMP-305B83, FOLFIRI and FOLFOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2016to Dec 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
- Age >21 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function
- For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Receiving any other investigational agents or any other anti-cancer therapy
- Receiving prior hepatic intra-arterial chemotherapy
- Known significant clinically significant gastrointestinal disease
- Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
- Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
- Pregnant or nursing women
- Inability to comply with study and follow up procedure
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109-2800
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
City of Hope National Medical Center
Duarte, California, 91010
Cancer Care & Hematology - Fort Collins
Fort Collins, Colorado, 80528
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With Metastatic Colorectal Cancer
The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.
The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor.
Read the detailed description
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus FOLFIRI or FOLFOX to evaluate the safety, efficacy, and pharmacokinetics of OMP-305B83 in combination with FOLFIRI or FOLFOX in patients with metastatic Colorectal Cancer. This study consists of a screening period, a treatment period, and a post-treatment follow-up period in which patients will be followed for survival for up to 5 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- OMP-305B83, FOLFIRI, FOLFOX
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMP-305B83Drug
Also called bispecific monoclonal antibody
FOLFIRIDrug
Treatment will consist of OMP-305B83 and the FOLFIRI chemotherapy regimen.
FOLFOXDrug
Treatment will consist of OMP-305B83 and the FOLFOX chemotherapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| OMP-305B83 combined with FOLFIRI or FOLFOX | Experimental | Not described Receives: Drug: OMP-305B83; Drug: FOLFIRI; Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX
Measured: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
Secondary outcomes (5)
Safety of OMP-305B83 in combination with FOLFIRI or FOLFOX will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.
Measured: Through study completion, an average of 8 months
Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with FOLFIRI or FOLFOX
Measured: Through study completion, an average of 8 months
Response Rate assessed by RECIST criteria 1.1
Measured: At 56 day intervals while on treatment, through study completion, an average of 8 months
Response Rate assessed by tumor marker CEA
Measured: At 28 day intervals while on treatment, through study completion, an average of 8 months
Progression Free Survival
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionSep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035253
- Sponsor's protocol ID
- B83-003
- Status last verified
- Aug 2020
- First submitted
- 22 Dec 2016
- Last updated
- 11 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03035253
- Acronym / sponsor ID
- B83-003
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 Jan 2017 (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.
The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.
The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor.
Detailed description
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus FOLFIRI or FOLFOX to evaluate the safety, efficacy, and pharmacokinetics of OMP-305B83 in combination with FOLFIRI or FOLFOX in patients with metastatic Colorectal Cancer. This study consists of a screening period, a treatment period, and a post-treatment follow-up period in which patients will be followed for survival for up to 5 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMP-305B83 combined with FOLFIRI or FOLFOX | Experimental | Drug: OMP-305B83, Drug: FOLFIRI, Drug: FOLFOX |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
- Age >21 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function
- For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
Key exclusion criteria (7 listed)
- Receiving any other investigational agents or any other anti-cancer therapy
- Receiving prior hepatic intra-arterial chemotherapy
- Known significant clinically significant gastrointestinal disease
- Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
- Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
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 |
|---|---|---|
| OMP-305B83Also: bispecific monoclonal antibody | Drug | OMP-305B83 combined with FOLFIRI or FOLFOX |
| FOLFIRITreatment will consist of OMP-305B83 and the FOLFIRI chemotherapy regimen. | Drug | OMP-305B83 combined with FOLFIRI or FOLFOX |
| FOLFOXTreatment will consist of OMP-305B83 and the FOLFOX chemotherapy regimen. | Drug | OMP-305B83 combined with FOLFIRI or FOLFOX |
Primary outcome
Incidence of dose limiting toxicities
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX
5 secondary outcomes
Safety of OMP-305B83 in combination with FOLFIRI or FOLFOX will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.
Time frame: Through study completion, an average of 8 months
Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with FOLFIRI or FOLFOX
Time frame: Through study completion, an average of 8 months
Response Rate assessed by RECIST criteria 1.1
Time frame: At 56 day intervals while on treatment, through study completion, an average of 8 months
Response Rate assessed by tumor marker CEA
Time frame: At 28 day intervals while on treatment, through study completion, an average of 8 months
Progression Free Survival
Time frame: Up to 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OMP-305B83, FOLFIRI and FOLFOX in people with Metastatic Colorectal Cancer, run by OncoMed Pharmaceuticals, Inc. at 6 sites in United States.
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 6 inclusion and 7 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).). 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 11 Aug 2020.