Clinical trial NCT06242470: A Study of MGC026 in Participants With Advanced Solid Tumors
Official title: A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Advanced Cancer
Metastatic Cancer
Squamous Cell Carcinoma of Head and Neck
Non Small Cell Lung Cancer
Small-cell Lung Cancer
Bladder Cancer
Sarcoma
Endometrial Cancer
Melanoma
Castration Resistant Prostatic Cancer
Cervical Cancer
Colorectal Cancer
Gastric Cancer
Gastro-esophageal Cancer
Pancreas Cancer
Clear Cell Renal Cell Carcinoma
Hepatocellular Carcinoma
Platinum-resistant Ovarian Cancer
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of participants with adverse events (AEs) and serious AEs (SAEs)
timeFrame: Throughout the study, up to 135 weeks
Secondary outcomes:
measure: Overall response rate in advanced solid tumors
timeFrame: Throughout the study, up to 135 weeks
measure: Duration of response (DoR) in advanced solid tumors
timeFrame: Throughout the study, up to 135 weeks
measure: ORR rate in metastatic castration resistant prostate cancer (mCRPC)
timeFrame: Throughout the study, up to 135 weeks
measure: DoR in mCRPC
timeFrame: Throughout the study, up to 135 weeks
measure: Mean (standard deviation [SD]) of MGC026 maximum serum concentration (Cmax)
timeFrame: Day 1 of every 21-day cycle, throughout the study, average of 1 year.
measure: Mean (SD) of MGC026 area under the time concentration curve (AUC)
timeFrame: Day 1 of every 21-day cycle, throughout the study, average of 1 year.
measure: Number of participants who develop anti-MGC026 antibodies (immunogenicity)
timeFrame: Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Portland
country: United States
facility: Providence Cancer Institute
state: Oregon
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: Auchenflower
country: Australia
facility: ICON Cancer Centre Wesley
state: Queensland
city: Kurralta Park
country: Australia
facility: ICON Cancer Centre Kurralta Park
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Health- Olivia Newton John Cancer Center
state: Victoria
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: MacroGenics
name: Denise Casey, MD
role: STUDY_DIRECTOR
References: