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Advanced Solid TumorsPhase 1NCT03406949

MGD009/MGA012 Combination in Relapsed/Refractory Cancer

A Phase 1 study testing obrindatamab and retifanlimab in people with Advanced Solid Tumors, run by MacroGenics at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of obrindatamab administered in combination with retifanlimab in patients with B7-H3- expressing tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
obrindatamab and retifanlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
10 sitesUnited States
Study dates
27 Feb 2018to 27 Apr 2022
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

  • Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy ≥ 12 weeks
  • Measurable disease, with the exception of prostate cancer
  • Tissue specimen available for B7-H3 and PD-L1 expression testing
  • Acceptable laboratory parameters
  • Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to ≤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.

Who cannot join

  • Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment:
  • No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent)
  • 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
  • Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing
  • Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration
Show all 14Show fewer
  • Treatment with any systemic chemotherapy within 3 weeks
  • Treatment with radiation therapy within 2 weeks
  • History of allogeneic bone marrow, stem-cell, or solid organ transplant
  • Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks
  • Clinically significant cardiovascular or pulmonary disease
  • Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.
  • Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
  • Known 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

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Mary Crowley Cancer Center

    Dallas, Texas, 75251

  • City of Hope Medical Center

    Duarte, California, 91010

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • START (South Texas Accelerated Research Therapeutics) - Midwest

    Grand Rapids, Michigan, 49546

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Southern California

    Los Angeles, California, 90033

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

Other trials in United States

About this study

Official title: A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DART® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of obrindatamab administered in combination with retifanlimab in patients with B7-H3- expressing tumors.

Read the detailed description

This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of obrindatamab and retifanlimab, each of which is administered by IV infusion. The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (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. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.

Being tested
obrindatamab, retifanlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • obrindatamabBiological

    Also called MGD009

    B7-H3 x CD3 DART protein

  • retifanlimabBiological

    Also called INCMGA00012, MGA012

    anti-PD-1 antibody

Study groups in NCT03406949
Study groupRoleWhat they receive
obrindatamab + retifanlimabExperimentalB7-H3 x CD3 DART protein + anti-PD-1 antibody
Receives: Biological: obrindatamab; Biological: retifanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03

    Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.

    Measured: 30 months

  2. MTD/MAD

    Maximum Tolerated or Administrated Dose of obrindatamab and retifanlimab

    Measured: 18 months

Secondary outcomes (9)

  1. AUC

    Area Under the Plasma Concentration versus Time Curve of obrindatamab and retifanlimab

    Measured: 30 months

  2. Cmax

    Maximum Plasma Concentration of obrindatamab and retifanlimab

    Measured: 30 months

  3. Tmax

    Time to reach maximum (peak) plasma concentration of obrindatamab and retifanlimab

    Measured: 30 months

  4. Ctrough

    Trough plasma concentration of obrindatamab and retifanlimab

    Measured: 30 months

  5. CL

    Total body clearance of the drug from plasma of obrindatamab and retifanlimab

    Measured: 30 months

  6. Vss

    Apparent volume of distribution at steady state of obrindatamab and retifanlimab

    Measured: 30 months

  7. t1/2

    Terminal half life of obrindatamab and retifanlimab

    Measured: 30 months

  8. ADA

    Percent of patients with anti-drug antibody to obrindatamab and retifanlimab

    Measured: 30 months

  9. Anti-tumor activity

    Conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start27 Feb 2018
  3. Primary completion27 Apr 2022
  4. Study completion27 Apr 2022

Resources

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
Model description
3+3+3 dose escalation design followed by Cohort Expansion Phase.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406949
Sponsor's protocol ID
CP-MGD009-02
Status last verified
May 2022
First submitted
16 Jan 2018
Last updated
19 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing obrindatamab and retifanlimab in people with Advanced Solid Tumors, run by MacroGenics at 10 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 7 inclusion and 14 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 19 May 2022. 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 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 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?

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03406949.

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 19 May 2022.

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