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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06242470




Registration number
NCT06242470
Ethics application status
Date submitted
12/01/2024
Date registered
5/02/2024
Date last updated
23/07/2024

Titles & IDs
Public title
A Study of MGC026 in Participants With Advanced Solid Tumors
Scientific title
A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
CP-MGC026-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Advanced Cancer 0 0
Metastatic Cancer 0 0
Squamous Cell Carcinoma of Head and Neck 0 0
Non Small Cell Lung Cancer 0 0
Small-cell Lung Cancer 0 0
Bladder Cancer 0 0
Sarcoma 0 0
Endometrial Cancer 0 0
Melanoma 0 0
Castration Resistant Prostatic Cancer 0 0
Cervical Cancer 0 0
Colorectal Cancer 0 0
Gastric Cancer 0 0
Gastro-esophageal Cancer 0 0
Pancreas Cancer 0 0
Clear Cell Renal Cell Carcinoma 0 0
Hepatocellular Carcinoma 0 0
Platinum-resistant Ovarian Cancer 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
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MGC026 Dose Escalation
Treatment: Other - MGC026 Dose for Expansion

Experimental: Cohort 1 -

Experimental: Cohort 2 -

Experimental: Cohort 3 -

Experimental: Cohort 4 -

Experimental: Cohort 5 -

Experimental: Cohort 6 -

Experimental: Expansion cohort 1 -

Experimental: Expansion cohort 2 -

Experimental: Expansion cohort 3 -

Experimental: Expansion cohort 4 -


Treatment: Other: MGC026 Dose Escalation
Escalating doses of MGC026

Treatment: Other: MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs) and serious AEs (SAEs)
Timepoint [1] 0 0
Throughout the study, up to 135 weeks
Secondary outcome [1] 0 0
Overall response rate in advanced solid tumors
Timepoint [1] 0 0
Throughout the study, up to 135 weeks
Secondary outcome [2] 0 0
Duration of response (DoR) in advanced solid tumors
Timepoint [2] 0 0
Throughout the study, up to 135 weeks
Secondary outcome [3] 0 0
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
Timepoint [3] 0 0
Throughout the study, up to 135 weeks
Secondary outcome [4] 0 0
DoR in mCRPC
Timepoint [4] 0 0
Throughout the study, up to 135 weeks
Secondary outcome [5] 0 0
Mean (standard deviation [SD]) of MGC026 maximum serum concentration (Cmax)
Timepoint [5] 0 0
Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Secondary outcome [6] 0 0
Mean (SD) of MGC026 area under the time concentration curve (AUC)
Timepoint [6] 0 0
Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Secondary outcome [7] 0 0
Number of participants who develop anti-MGC026 antibodies (immunogenicity)
Timepoint [7] 0 0
Day 1 of every 21-day cycle, throughout the study, average of 1 year.

Eligibility
Key inclusion criteria
* Adults = 18 years old, able to provide informed consent
* Adequate performance and laboratory parameters
* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.
* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.
* Not 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.
* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.
* 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 magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.
* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
* Prior autologous or allogeneic stem cell or solid organ transplant.
* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.
* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week 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.
* History of primary immunodeficiency.
* Major trauma or major surgery within 4 weeks of first study drug administration.
* Known hypersensitivity to recombinant proteins.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2028
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
ICON Cancer Centre Wesley - Auchenflower
Recruitment hospital [2] 0 0
ICON Cancer Centre Kurralta Park - Kurralta Park
Recruitment hospital [3] 0 0
Austin Health- Olivia Newton John Cancer Center - Heidelberg
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Oregon
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah

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

Ethics approval
Ethics application status

Summary
Brief summary
The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.

Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.
Trial website
https://clinicaltrials.gov/study/NCT06242470
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Denise Casey, MD
Address 0 0
MacroGenics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Global Trial Manager
Address 0 0
Country 0 0
Phone 0 0
301-251-5172
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06242470