Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03729596
Registration number
NCT03729596
Ethics application status
Date submitted
30/10/2018
Date registered
2/11/2018
Date last updated
31/07/2025
Titles & IDs
Public title
MGC018 With or Without MGA012 in Advanced Solid Tumors
Query!
Scientific title
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors
Query!
Secondary ID [1]
0
0
CP-MGC018-01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of Head and Neck
0
0
Query!
Triple Negative Breast Cancer
0
0
Query!
Melanoma
0
0
Query!
Advanced Solid Tumor, Adult
0
0
Query!
Metastatic Castrate Resistant Prostate Cancer
0
0
Query!
Non Small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Head and neck
Query!
Cancer
0
0
0
0
Query!
Breast
Query!
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - vobramitamab duocarmazine
Experimental: Cohort 1 - 0.5 mg/kg IV every 3 weeks
Experimental: Cohort 2 - 1.0 mg/kg IV every 3 weeks
Experimental: Cohort 3 - 2.0 mg/kg IV every 3 weeks
Experimental: Cohort 4 - 3.0 mg/kg IV every 3 weeks
Experimental: Cohort 5 - 4.0 mg/kg IV every 3 weeks
Experimental: mCRPC expansion - 3.0 mg/kg IV every 3 weeks
Experimental: NSCLC expansion - 3.0 mg/kg IV every 3 weeks
Experimental: TNBC expansion - 3.0 mg/kg IV every 3 weeks
Experimental: Melanoma expansion - 3.0 mg/kg IV every 3 weeks
Experimental: SCCHN expansion - 3.0 mg/kg IV every 3 weeks
Treatment: Other: vobramitamab duocarmazine
Anti-B7H3 antibody drug conjugate
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Patients With Adverse Events of Vobramitamab Duocarmazine as Assessed by CTCAE v4.03
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Throughout the study up to 24 months
Query!
Primary outcome [2]
0
0
Number of Participants With Dose Limiting Toxicities (DLT)
Query!
Assessment method [2]
0
0
Number of participants with severe side effects from study treatment during the DLT evaluation period (6 weels)
Query!
Timepoint [2]
0
0
up to 42 days from first dose
Query!
Secondary outcome [1]
0
0
Best Overall Response (BOR) of Vobramitamab Duocarmazine
Query!
Assessment method [1]
0
0
The best response recorded from the start of the study treatment until the end of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, taking into account any requirement for confirmation of response. Complete response (CR) is defined as disappearance of all target and non-target lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions, and no new lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of non-target lesions, or appearance of new lesions. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progression. Not evaluable (NE) is where the response cannot be determined.
Query!
Timepoint [1]
0
0
Throughout the study for up to 24 months
Query!
Secondary outcome [2]
0
0
Objective Response Rate (ORR) of Vobramitamab Duocarmazine
Query!
Assessment method [2]
0
0
The percentage of participants who achieve a complete response (CR or partial response (PR) to treatment with vobramitamab duocarmazine
Query!
Timepoint [2]
0
0
Efficacy evaluations every 9 weeks throughout the study for up to 24 months
Query!
Secondary outcome [3]
0
0
Progression Free Survival (PFS) of Vobramitamab Duocarmazine
Query!
Assessment method [3]
0
0
PFS is calculated from the first dose date until the date of first documented PD using RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of non-target lesions, or appearance of new lesions. Median PFS and 95% CI is estimated using the Kaplan-Meier method.
Query!
Timepoint [3]
0
0
Every 9 weeks for up to 24 months
Query!
Secondary outcome [4]
0
0
Median Duration of Response (DoR) of Vobramitamab Duocarmazine
Query!
Assessment method [4]
0
0
Median DoR assessed as the time from the date of initial objective response to the date of first documented PD, per RECIST v1.1, or the date of death from any cause, whichever occurs first. Median DoR and 95% CI is estimated using the Kaplan-Meier method.
Query!
Timepoint [4]
0
0
Throughout the study for up to 48 months
Query!
Secondary outcome [5]
0
0
Median Overall Survival (OS) of Vobramitamab Duocarmazine
Query!
Assessment method [5]
0
0
Median OS assessed as the time from the first dose date to the date of death from any cause, using the Kaplan-Meier method for estimating median and confidence interval. .
Query!
Timepoint [5]
0
0
Every 9 weeks for up to 24 months
Query!
Secondary outcome [6]
0
0
PSA Response Rate
Query!
Assessment method [6]
0
0
Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA) with confirmation at least 3 weeks later
Query!
Timepoint [6]
0
0
Every 3 weeks up to 24 months
Query!
Secondary outcome [7]
0
0
Best PSA Response
Query!
Assessment method [7]
0
0
For prostate cancer patients, the greatest change from baseline in PSA.
Query!
Timepoint [7]
0
0
Every 3 weeks up to 24 months
Query!
Secondary outcome [8]
0
0
Mean Area Under the Curve (AUC) of Vobramitamab Duocarmazine Antibody Drug Conjugate (ADC)
Query!
Assessment method [8]
0
0
Area under the plasma concentration versus time curve of vobramitamab duocarmazine
Query!
Timepoint [8]
0
0
At baseline, Cycle 1, Day 1: 1 hour, 4 hours after the first dose, Day 2, Day 3, Day 7, Day 14 and Cycle 2 Day 1 (approximately 21 days after the first dose).
Query!
Secondary outcome [9]
0
0
Mean AUC of Duocarmycin
Query!
Assessment method [9]
0
0
Area under the plasma concentration versus time curve of duocarmycin (unconjugated payload) in the bloodstream
Query!
Timepoint [9]
0
0
At baseline, Cycle 1, Day 1: 1 hour, 4 hours after the first dose, Day 2, Day 3, Day 7, Day 14 and Cycle 2 Day 1 (approximately 21 days after the first dose).
Query!
Secondary outcome [10]
0
0
Mean Maximum Concentration Vobramitamab Duocarmazine ADC
Query!
Assessment method [10]
0
0
Maximum Plasma Concentration of vobramitamab duocarmazine ADC in the bloodstream
Query!
Timepoint [10]
0
0
At baseline, Cycle 1, Day 1, 1 and 4 hours after the end of infusion, Day 2, and Day 3.
Query!
Secondary outcome [11]
0
0
Mean Maximum Concentration Duocarmycin
Query!
Assessment method [11]
0
0
Maximum Plasma Concentration of vobramitamab duocarmazine ADC in the bloodstream
Query!
Timepoint [11]
0
0
At baseline, Cycle 1, Day 1, 1 and 4 hours after the end of infusion, Day 2, and Day 3.
Query!
Secondary outcome [12]
0
0
Mean Trough Concentration of Vobramitamab Duocarmazine ADC
Query!
Assessment method [12]
0
0
Average trough plasma concentration of vobramitamab duocarmazine ADC in the bloodstream.
Query!
Timepoint [12]
0
0
At baseline, and before subsequent infusion Cycle 2, Day 1 (Study Day 22).
Query!
Secondary outcome [13]
0
0
Mean Trough Concentration of Duocarmycin
Query!
Assessment method [13]
0
0
Average trough plasma concentration of duocarmycin unconjugated payload in the bloodstream.
Query!
Timepoint [13]
0
0
At baseline, and before subsequent infusion Cycle 2, Day 1 (Study Day 22).
Query!
Secondary outcome [14]
0
0
Number of Participants Who Develop MGC018 Anti-drug Antibodies
Query!
Assessment method [14]
0
0
Shifts in MGC018 anti-drug antibodies after treatment with vobramitamab duocarmazine
Query!
Timepoint [14]
0
0
Every 3 weeks through end of treatment, up to 24 months
Query!
Eligibility
Key inclusion criteria
* Tissue specimen available for retrospective analysis of B7-H3 and PD-L1 expression.
* Eastern Cooperative Oncology Group performance status of =2
* Life expectancy = 12 weeks for dose escalation phase and = 24 weeks for cohort expansion phase
* Measurable disease. Prostate cancer patients with bone only disease are eligible.
* Acceptable laboratory parameters and adequate organ reserve.
* Dose Escalation Phase: Patients with histologically proven, unresectable, locally advanced or metastatic solid tumors for whom no therapy with demonstrated clinical benefit is available.
Module A Cohort Expansion:
* mCRPC that has progressed with one prior line of chemotherapy for metastatic disease and no more than two prior lines of anti-hormonal therapy.
* NSCLC: metastatic disease after standard cytotoxic, targeted, and biologic or checkpoint inhibitor therapy. No more than 2 prior lines of chemotherapy.
* TNBC: Locally advance or metastatic disease that has progressed following at least one systemic therapy.
* SCCHN that has progressed during or following at least one systemic therapy for metastatic or recurrent unresectable disease. No more than 2 prior lines of chemotherapy.
* Melanoma that has progressed during or following at least one systemic treatment for unresectable locally advanced or metastatic disease. Patients who are intolerant of or refused standard therapy are eligible.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on MRI, CT or PET within 6 months, or history of leptomeningeal disease or cord compression at the time of enrollment.
* Prior treatment with B7-H3 targeted agents for cancer.
* Treatment with systemic cancer therapy, biologic agents, or anti-hormonal therapy (mCRPC) within 4 weeks, prior small molecule targeted or kinase inhibitors within 14 days or 5 half-lives, prior radioligand within 6 months
* Clinically significant cardiovascular disease.
* Clinically significant pulmonary compromise or requirement for supplemental oxygen.
* History of clinically-significant cardiovascular disease, including but not limited to pericarditis or pericardial effusion.
* Active viral (including confirmed or presumed COVID-19), 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.
* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
* Major trauma or major surgery within 4 weeks of first study drug administration.
* Clinically significant venous insufficiency.
* > Grade 1 peripheral neuropathy.
* Evidence of pleural effusion.
* Evidence of ascites.
* Serum testosterone >50 ng/dl or >1.7 nmol/L in mCRPC in Module A Cohort Expansion Phase
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/11/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/03/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
143
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
St Vincent's Health Network (Kinghorn Cancer Centre) - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Austin Health - Olivia Newton John Cancer Center - Heidelberg
Query!
Recruitment hospital [3]
0
0
Calvary Mater NewCastle - Waratah
Query!
Recruitment hospital [4]
0
0
The University of Queensland - Princess Alexandra Hospital (PAH) - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [3]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [4]
0
0
4105 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Michigan
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Nebraska
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Nevada
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Virginia
Query!
Country [9]
0
0
Poland
Query!
State/province [9]
0
0
Krakow
Query!
Country [10]
0
0
Poland
Query!
State/province [10]
0
0
Poznan
Query!
Country [11]
0
0
Poland
Query!
State/province [11]
0
0
Warsaw
Query!
Country [12]
0
0
Spain
Query!
State/province [12]
0
0
Barcelona
Query!
Country [13]
0
0
Spain
Query!
State/province [13]
0
0
Madrid
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
MacroGenics
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of vobramitamab duocarmazine (MGC018) in patients with advanced solid tumors. Patients with solid tumors will be enrolled in the Dose Escalation Phase; Cohort Expansion will include metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), squamous cell carcinoma of the head and neck (SCCHN), and melanoma. Patients who do not experience unacceptable toxicity or meet criteria for permanent discontinuation may undergo additional cycles for up to two years. Patients in Cohort Expansion will be followed for survival every 3 months for 2 years following last dose.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03729596
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Ashley Ward, M.D.
Query!
Address
0
0
MacroGenics
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/96/NCT03729596/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/96/NCT03729596/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03729596
Download to PDF