Colorectal Cancer MetastaticPhase 1/2NCT03531632
MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer
A Phase 1/2 study testing MGD007 + MGA012 in people with Colorectal Cancer Metastatic, run by MacroGenics at 6 sites in United States.
Trial summary
The primary goal of this study is to characterize the safety, tolerability, and maximum tolerated dose (MTD) of MGD007 when combined with MGA012. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of the combination of MGD007 and MGA012 will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- MGD007 + MGA012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 6 sitesUnited States
- Study dates
- 4 Jun 2018to 8 Feb 2020
- Phase
- Phase 1/2
- 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
- Histologically proven, relapsed/refractory metastatic colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease per RECIST 1.1 criteria
- Participants in the Dose Escalation Phase must have had recurrence, progression or intolerance to standard therapy consisting of at least 2 prior standard regimens (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease. Participants in the Cohort Expansion portion will be allowed to participate after 1 prior standard regimen. Those who are inappropriate candidates for or have refused treatment with these regimens are also eligible. No more than 5 prior therapies are permitted. Patients previously treated with MGD007 on Study Protocol CP-MGD007-01 and who did not develop antibodies to MGD007 while on the CP-MGD007-01 study, may be enrolled. Patients that were previously treated on CP-MGD007-01 will only be treated on this study once MTD/MAD has been defined.
- Availability of sufficient tumor specimens to enable retrospective determination of gpA33, CD3, PD-1, and PD-L1 expression
- 30 participants in the Cohort Expansion portion must have lesions that are accessible for paired biopsies with acceptable clinical risk in the judgment of the investigator.
Who cannot join
- Symptomatic central nervous system (CNS) metastases. No concurrent treatment for the CNS disease; no progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases; no concurrent leptomeningeal disease or cord compression
- History of known or suspected autoimmune disease with certain exceptions
- History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation.
- Major surgery, systemic anti-neoplastic therapy, or investigational therapy within 4 weeks
- Radiation therapy within 2 weeks
- Systemic corticosteroids (≥ 10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days
Show all 10Show fewer
- History of Grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors including anti-LAG-3, anti-PD-1, anti PD-L1, or anti-CTLA-4 antibodies
- Clinically significant cardiovascular disease; gastrointestinal disorders; pulmonary compromise; viral, bacterial, or systemic fungal infections
- History of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
- History of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Carolina Biooncology Institute
Huntersville, North Carolina, 28078
Yale School of Medicine
New Haven, Connecticut, 06520
University of Rochester Medical Center
Rochester, New York, 14642
University of Washington
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1b/2, Open Label, Dose Escalation Study of MGD007, a Humanized gpA33 × CD3 DART® Protein in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory Metastatic Colorectal Carcinoma
The primary goal of this study is to characterize the safety, tolerability, and maximum tolerated dose (MTD) of MGD007 when combined with MGA012. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of the combination of MGD007 and MGA012 will also be assessed.
Read the detailed description
This study is an open-label, Phase 1b/2, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of MGD007 and MGA012, administered in combination by IV infusion, in patients with histologically proven, relapsed/refractory metastatic colorectal carcinoma, irrespective of the KRAS and MMR status of their tumors.
The study consists of a Dose Escalation Phase to determine the MTD or Maximum Administered Dose (MAD; if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- MGD007 + MGA012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGD007 + MGA012Biological
Also called MGA012 also known as INCMGA00012
MGD007 and MGA012 are administered by IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| MGD007 + MGA012 | Experimental | MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody. Receives: Biological: MGD007 + MGA012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Adverse Events, Serious Adverse Events
Measured: Up to approximately 12 weeks
Secondary outcomes (3)
Peak Plasma Concentration
PK of MGD007 and MGA012 in combination
Measured: 7 weeks
Number of Participants That Develop Anti-drug Antibodies
Proportion of patients who develop anti-MGD007/MGA012 antibodies, immunogenicity
Measured: 1 year
The Number of Participants With Response Based on the Change in Tumor Volume
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immune related RECIST criteria: number of patients with either complete response (CR) or partial response (PR) will determine the Overall Response Rate (ORR)
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start4 Jun 2018
- Primary completion8 Feb 2020
- Study completion8 Feb 2020
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 Colorectal Cancer MetastaticStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531632
- Sponsor's protocol ID
- CP-MGD007-02
- Status last verified
- Feb 2022
- First submitted
- 9 May 2018
- Last updated
- 8 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open Label, Dose Escalation Study of MGD007, a Humanized gpA33 × CD3 DART® Protein in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT03531632
- Acronym / sponsor ID
- CP-MGD007-02
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 8 Feb 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Posted 10 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this study is to characterize the safety, tolerability, and maximum tolerated dose (MTD) of MGD007 when combined with MGA012. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of the combination of MGD007 and MGA012 will also be assessed.
Detailed description
This study is an open-label, Phase 1b/2, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of MGD007 and MGA012, administered in combination by IV infusion, in patients with histologically proven, relapsed/refractory metastatic colorectal carcinoma, irrespective of the KRAS and MMR status of their tumors.
The study consists of a Dose Escalation Phase to determine the MTD or Maximum Administered Dose (MAD; if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGD007 + MGA012 | Experimental | Biological: MGD007 + MGA012MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven, relapsed/refractory metastatic colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease per RECIST 1.1 criteria
- Participants in the Dose Escalation Phase must have had recurrence, progression or intolerance to standard therapy consisting of at least 2 prior standard regimens (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease. Participants in the Cohort Expansion portion will be allowed to participate after 1 prior standard regimen. Those who are inappropriate candidates for or have refused treatment with these regimens are also eligible. No more than 5 prior therapies are permitted. Patients previously treated with MGD007 on Study Protocol CP-MGD007-01 and who did not develop antibodies to MGD007 while on the CP-MGD007-01 study, may be enrolled. Patients that were previously treated on CP-MGD007-01 will only be treated on this study once MTD/MAD has been defined.
- Availability of sufficient tumor specimens to enable retrospective determination of gpA33, CD3, PD-1, and PD-L1 expression
Key exclusion criteria (10 listed)
- Symptomatic central nervous system (CNS) metastases. No concurrent treatment for the CNS disease; no progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases; no concurrent leptomeningeal disease or cord compression
- History of known or suspected autoimmune disease with certain exceptions
- History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation.
- Major surgery, systemic anti-neoplastic therapy, or investigational therapy within 4 weeks
- Radiation therapy within 2 weeks
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 |
|---|---|---|
| MGD007 + MGA012Also: MGA012 also known as INCMGA00012MGD007 and MGA012 are administered by IV infusion. | Biological | MGD007 + MGA012 |
Primary outcome
Number of Participants With Adverse Events
Time frame: Up to approximately 12 weeks
Adverse Events, Serious Adverse Events
3 secondary outcomes
Peak Plasma Concentration
Time frame: 7 weeks
Number of Participants That Develop Anti-drug Antibodies
Time frame: 1 year
The Number of Participants With Response Based on the Change in Tumor Volume
Time frame: Every 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 1/2 study testing MGD007 + MGA012 in people with Colorectal Cancer Metastatic, run by MacroGenics 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 10 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 8 Feb 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Nov 2021). 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 (time frame: Up to approximately 12 weeks). 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 8 Feb 2022.