Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05551117




Registration number
NCT05551117
Ethics application status
Date submitted
19/09/2022
Date registered
22/09/2022
Date last updated
10/05/2024

Titles & IDs
Public title
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
Scientific title
A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
Secondary ID [1] 0 0
CP-MGC018-03
Universal Trial Number (UTN)
Trial acronym
Tamarack
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Castration-Resistant Prostatic Cancer 0 0
Androgen-Independent Prostatic Cancer 0 0
Androgen-Insensitive Prostatic Cancer 0 0
Androgen-Resistant Prostatic Cancer 0 0
Hormone Refractory Prostatic Cancer 0 0
Anal Cancer 0 0
Anal Neoplasm 0 0
Carcinoma, Squamous Cell of Head and Neck 0 0
Head and Neck Squamous Cell Carcinoma 0 0
Laryngeal Squamous Cell Carcinoma 0 0
Oral Squamous Cell Carcinoma 0 0
Malignant Melanoma 0 0
Melanoma 0 0
Non-small Cell Lung Cancer 0 0
Non-small Cell Carcinoma 0 0
Small-cell Lung Cancer 0 0
Small Cell Carcinoma 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 - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - vobramitamab duocarmazine 2.0 mg (Arm A)
Other interventions - vobramitamab duocarmazine 2.7 mg (Arm B)
Other interventions - vobramitamab duocarmazine

Experimental: Part 1: MGC018 2.0 mg (Arm A) - MGC018 2.0 mg/kg every 4 weeks

Experimental: Part 1: MGC018 2.7 mg (Arm B) - MGC018 2.7 mg/kg every 4 weeks

Experimental: Part 2: Anal cancer cohort - MGC018 2.7 mg/kg every 4 weeks

Experimental: Part 2: HNSCC cohort - MGC018 2.7 mg/kg every 4 weeks

Experimental: Part 2: Melanoma cohort - MGC018 2.7 mg/kg every 4 weeks

Experimental: Part 2: Squamous NSCLC cohort - MGC018 2.7 mg/kg every 4 weeks

Experimental: Part 2: SCLC cohort - MGC018 2.7 mg/kg every 4 weeks


Other interventions: vobramitamab duocarmazine 2.0 mg (Arm A)
2.0 mg/kg intravenous (IV) every 4 weeks

Other interventions: vobramitamab duocarmazine 2.7 mg (Arm B)
2.7 mg.kg IV every 4 weeks

Other interventions: vobramitamab duocarmazine
2.7 mg.kg IV every 4 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Radiographic progression free survival (rPFS) as determined by the investigator
Timepoint [1] 0 0
Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
Primary outcome [2] 0 0
Part 2: Objective response rate (ORR) per investigator assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
Timepoint [2] 0 0
Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
Secondary outcome [1] 0 0
Part 1: ORR per PCWG3 criteria as determined by the investigator
Timepoint [1] 0 0
as determined by the investigator
Secondary outcome [2] 0 0
Part 1: Duration of response (DoR) per PCWG3 criteria as determined by the investigator
Timepoint [2] 0 0
Every 8 weeks throughout study participation, up to 2 years
Secondary outcome [3] 0 0
Part 1: Prostate-specific Cancer Antigen (PSA) response rate per PCWG3 criteria
Timepoint [3] 0 0
Every 4 weeks throughout study participation, up to 2 years
Secondary outcome [4] 0 0
Part 1: Time to PSA progression per PCWG3 criteria
Timepoint [4] 0 0
Every 4 weeks throughout study participation, up to 2 years
Secondary outcome [5] 0 0
Part 1: Duration of PSA response per PCWG3 criteria
Timepoint [5] 0 0
Every 4 weeks throughout study participation, up to 2 years
Secondary outcome [6] 0 0
Part 1: PSA percent change over time
Timepoint [6] 0 0
Every 4 weeks throughout study participation, up to 2 years
Secondary outcome [7] 0 0
Part 1: Best PSA percent change
Timepoint [7] 0 0
Every 4 weeks throughout study participation, up to 2 years
Secondary outcome [8] 0 0
Part 1: Time to first symptomatic skeletal event (SSE)
Timepoint [8] 0 0
Every 4 weeks throughout the study, up to 2 years
Secondary outcome [9] 0 0
Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation.
Timepoint [9] 0 0
Throughout the study, up to 2 years
Secondary outcome [10] 0 0
Number of participants who develop anti-drug antibodies
Timepoint [10] 0 0
Throughout the study, up to 2 years
Secondary outcome [11] 0 0
Part 2: DoR per investigator assessment of RECIST 1.1 criteria
Timepoint [11] 0 0
Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
Secondary outcome [12] 0 0
Part 2: Progression free survival (PFS) per investigator assessment of RECIST 1.1 criteria
Timepoint [12] 0 0
Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years

Eligibility
Key inclusion criteria
- Part 1 only: Histologically confirmed adenocarcinoma of the prostate without evidence
of neuroendocrine differentiation, signet cell, or small cell features.

- Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamous
NSCLC, or SCLC.

- Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic,
castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of
<60 days used as bridging to lutetium-177 is permitted.

- Part 2 only: At least 1 prior line of systemic therapy for unresectable or metastatic
disease and no more than 2 prior lines of cytotoxic chemotherapy. Participants with
HNSCC or melanoma must have received prior PD-1 or PD-L1 inhibitor for advanced or
metastatic disease.

- All participants must have = 1 metastatic lesion, according to RECIST 1.1 or PCWG3
criteria, that is present on magnetic resonance imaging (MRI), computed tomography
(CT), or bone scan obtained = 28 days prior to initiation of study treatment.

- All participants must have tumor progression, according to disease-specific criteria,
following their most recent anti-cancer therapy.

- All participants must have and available archival or formalin-fixed paraffin-embedded
(FFPE) tumor tissue sample for participants with metastasis to internal organs

- All participants have acceptable physical condition and laboratory values.

- All participants of childbearing potential must agree to use highly effective methods
of birth control.

- All participants must not be pregnant, planning to be pregnant, or breastfeeding.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any underlying medical or psychiatric condition impairing participant's ability to
receive, tolerate, or comply with the planned treatment or study procedures.

- Part 1 only: Received >1 prior taxane-containing regimen for prostate cancer. A second
taxane regimen of <60 days used as bridging for lutetium-177 is permitted.

- Part 1 only: Received >3 total prior therapies for mCRPC

- Part 1 only: Participants with known BRCA or ATM mutation (germline or somatic) are
not eligible unless they received prior treatment with a PARP inhibitor where
available, indicated and tolerated.

- Another hematologic or solid tumor = stage 1 malignancy that completed surgery, last
dose of radiotherapy, or last dose of systemic anti-cancer therapy = 2 years from
first dose of study treatment. Participants who had curative therapy for
non-melanomatous skin cancer or for localized malignancy are eligible.

- Untreated, symptomatic central nervous system (CNS) metastasis.

- Prior treatment with any B7-H3 targeted agent for cancer,

- Contradictions to the use of corticosteroid treatment

- Prior stem cell, tissue, or solid organ transplant.

- Part 1 only: Use of products that have published anti-prostate cancer activity or are
known to decrease PSA.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2
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
13/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
382
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Ramsay Health Care - Westmead Private Hospital - Westmead
Recruitment hospital [2] 0 0
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH) - Woolloongabba
Recruitment hospital [3] 0 0
Cabrini Health- Malvern - Malvern
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussles
Country [13] 0 0
Belgium
State/province [13] 0 0
Hainaut
Country [14] 0 0
Belgium
State/province [14] 0 0
Luxembourg
Country [15] 0 0
Belgium
State/province [15] 0 0
Namur
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
France
State/province [17] 0 0
AM
Country [18] 0 0
France
State/province [18] 0 0
Bas Rhin
Country [19] 0 0
France
State/province [19] 0 0
Gironde
Country [20] 0 0
France
State/province [20] 0 0
Herault
Country [21] 0 0
France
State/province [21] 0 0
Ile De France
Country [22] 0 0
France
State/province [22] 0 0
Ille Et Vilaine
Country [23] 0 0
France
State/province [23] 0 0
Sarthe
Country [24] 0 0
France
State/province [24] 0 0
Val De Marne
Country [25] 0 0
France
State/province [25] 0 0
Brest
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
Italy
State/province [27] 0 0
TO
Country [28] 0 0
Italy
State/province [28] 0 0
Venice
Country [29] 0 0
Italy
State/province [29] 0 0
Florence
Country [30] 0 0
Italy
State/province [30] 0 0
Padova
Country [31] 0 0
Italy
State/province [31] 0 0
Trento
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Daegu
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Kyonggi
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Gwangju
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Poland
State/province [36] 0 0
Mazowieckie
Country [37] 0 0
Poland
State/province [37] 0 0
Wlkp
Country [38] 0 0
Poland
State/province [38] 0 0
Zachodniopomorskie
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Seville
Country [41] 0 0
Spain
State/province [41] 0 0
Lugo
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Surrey
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Oxford

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

Ethics approval
Ethics application status

Summary
Brief summary
Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll
participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated
with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone,
enzalutamide, or apalutamide. Participants may have received up to 1 prior
docetaxel-containing regimen, but no other chemotherapy agents.

This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine
(MGC018) in two experimental arms (2.0 mg/kg every 4 weeks [Q4W] and 2.7 mg/kg Q4W) .
Approximately 100 participants will be randomized 1:1.

Part 2 of the study will enroll participants with locally advanced or metastatic squamous
cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma (HNSCC),
squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma (SCLC).
Participants must have progressive following at least 1 prior line of standard chemotherapy
for advanced or metastatic disease. Participants will receive vobramitamab docarmazine at a
dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2.

In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on
Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26
cycles, approximately 2 years, until criteria for treatment discontinuation are met.
Participants will undergo regular testing for signs of disease progression using computed
tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific
antigen (PSA) blood tests. Routine examinations and blood tests will be performed and
evaluated by the study doctor.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05551117
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ashley Ward, 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