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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02628535




Registration number
NCT02628535
Ethics application status
Date submitted
20/11/2015
Date registered
11/12/2015
Date last updated
13/08/2019

Titles & IDs
Public title
Safety Study of MGD009 in B7-H3-expressing Tumors
Scientific title
Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms
Secondary ID [1] 0 0
CP-MGD009-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mesothelioma 0 0
Bladder Cancer 0 0
Melanoma 0 0
Squamous Cell Carcinoma of the Head and Neck 0 0
Non Small Cell Lung Cancer 0 0
Clear Cell Renal Cell Carcinoma 0 0
Ovarian Cancer 0 0
Thyroid Cancer 0 0
Breast Cancer 0 0
Pancreatic Cancer 0 0
Prostate Cancer 0 0
Colon Cancer 0 0
Soft Tissue Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Bladder - transitional cell cancer
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Thyroid
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MGD009

Experimental: MGD009 - Orlotamab; Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein


Other interventions: MGD009
B7-H3 x CD3 DART protein

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events - adverse events, serious adverse events
Timepoint [1] 0 0
28 days after last dose of study drug
Secondary outcome [1] 0 0
Peak plasma concentration - PK of MGD009
Timepoint [1] 0 0
8 days
Secondary outcome [2] 0 0
Number of participants that develop anti-drug antibodies - Proportion of patients who develop anti-MGD0009 antibodies, immunogenicity
Timepoint [2] 0 0
first dose through 28 days after last dose of study drug
Secondary outcome [3] 0 0
Change in tumor volume - Anti-tumor activity of MGD009 using both conventional RECIST 1.1 and immune-related RECIST criteria.
Timepoint [3] 0 0
Weeks 6, 15, 24, 33, 42, 51, 60, 69, 78, 87, 96, 105

Eligibility
Key inclusion criteria
- Histologically and/or cytologically proven unresectable locally advanced or metastatic
tumors that express B7-H3 on the membrane or vasculature. The requirement for previous
systemic therapy may be waived if a person was intolerant of standard front-line
therapy

- Dose escalation phase prior systemic treatment requirements:

- pleural mesothelioma, pancreatic cancer: 1-3 prior treatments

- urothelial, SCHNN, prostate, soft tissue sarcoma, prostate cancer, TNBC, ccRCC, NSCLC:
1-5 prior treatments

- ovarian cancer: 2-4 prior treatments

- colon cancer: 2-4 prior treatments

- cutaneous melanoma: at least 1 prior treatment (including immunotherapy).

- Patients with prior immune checkpoint inhibitors must have related toxicities reduced
to Grade 0, 1, or baseline

- Measurable disease per RECIST 1.1 criteria

- Easter Cooperative Oncology Group (ECOG) performance status 0 or 1

- Acceptable laboratory parameters and adequate organ reserve.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with central nervous system (CNS) involvement must have been treated, be
asymptomatic, do not exhibit progression of CNS metastases on MRI or CT within 28
days, and do not have concurrent leptomeningeal disease or cord compression.

- Clinically significant pulmonary compromise within 28 days of first dose, including
pneumonia, pneumonitis, requirement for supplemental oxygen). use to maintain adequate
oxygenation, or pleural effusion sufficient to warrant pleurocentesis or any history
of = Grade 3 drug induced or radiation pneumonitis.

- History of autoimmune disease with certain exceptions such as vitiligo, resolved
childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past
2 years, patients with history of Hashimoto's or Grave's disease that are now
euthyroid clinically and by lab testing

- History of clinically-significant cardiovascular disease, or cardiac arrhythmias,
including atrial fibrillation at screening or day of treatment

- History of clinically-significant gastrointestinal (GI) disease; GI perforation within
1 year; GI bleeding or acute pancreatitis within 3 months; or diverticulitis within 4
weeks of first study drug administration

- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment
within 7 days of first study drug administration

- Known history of hepatitis B or C infection or known positive test for hepatitis B
surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)

- Known positive testing for human immunodeficiency virus or history of acquired immune
deficiency syndrome

- History of allogeneic bone marrow, stem cell, or solid organ transplant

- Treatment with systemic cancer therapy or investigational therapy within 3 weeks of
first study drug administration; radiation within 2 weeks; corticosteroids (greater
than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive
drugs within 2 weeks of first study drug administration

- Trauma or major surgery within 4 weeks of first study drug administration

- Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient
contained in the drug or vehicle formulation for MGD009

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Saint Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MacroGenics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety of MGD009 when given to patients with
B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that
can be given safely. Assessments will be done to see how the drug acts in the body
(pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity
of MGD009.
Trial website
https://clinicaltrials.gov/show/NCT02628535
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stacie Goldberg, M.D.
Address 0 0
MacroGenics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications