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New treatment option for Head and Neck Cancer
Official title GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06265025
What this study is testing
What is GM103 (Part A)?
GM103 (Part A) is an investigational medicine, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include:
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must be 18 years of age or over, at the time of signing the informed consent.
- Have a diagnosis of locally advanced, unresectable, refractory and/or metastatic solid tumors
- Have a tumor that is accessible and is willing to consent to tumor biopsies during the study.
- Have at least one measurable site of disease according to RECIST 1.1 criteria; The lesions should be either previously non irradiated or progressive...
- Part A, B and C: Have at least one intratumorally injectable lesion (measurable and/or non-measurable based on RECIST 1.1), that can be accurately...
You likely can't join if
- Known history or eiciency virus [HIV]/acquired immunodeficiency syndrome [AIDS]) and/or medication.
- Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisolone equivalent) or other immunosuppressive...
- Patients with a history of, or active, known or suspected auto-immune disease or a syndrome that requires systemic or immunosuppressive agents.
- Active infections requiring antibiotics, physician monitoring or recurrent fevers (\>38.0 ̊C) associated with a clinical diagnosis of active...
- Patient who has a history of seizures, central nervous system abnormalities, mental disorders, and heart disease.
- Patient who has a history of pleural effusion, pulmonary embolism, and intestinal obstruction.
See the full eligibility criteria
- Patient must be 18 years of age or over, at the time of signing the informed consent.
- Have a diagnosis of locally advanced, unresectable, refractory and/or metastatic solid tumors
- Have a tumor that is accessible and is willing to consent to tumor biopsies during the study.
- Have at least one measurable site of disease according to RECIST 1.1 criteria; The lesions should be either previously non irradiated or progressive lesions after irradiation, that can be accurately measured at baseline...
- Part A, B and C: Have at least one intratumorally injectable lesion (measurable and/or non-measurable based on RECIST 1.1), that can be accurately measured at baseline (for measurable lesions) with computed tomography...
- Part B and C (only for dose expansion cohort): Have paired pre- and on treatment tumor biopsies for patients with metastases that are safely accessible as determined by the investigator.
- Patients with brain metastasis must have stable disease and must be neurologically asymptomatic and not requiring corticosteroid treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Have a predicted life expectancy of 12 weeks or more.
- Able to comply with study procedures in the Investigator's opinion.
- Adequate organ function determined within 4 weeks prior to screening
- Patient is male or female.
- Contraceptive use by women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Patient is capable of giving signed informed consent.
- Known history or eiciency virus [HIV]/acquired immunodeficiency syndrome [AIDS]) and/or medication.
- Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisolone equivalent) or other immunosuppressive medications within 14 days of the first dose of study treatment.
- Patients with a history of, or active, known or suspected auto-immune disease or a syndrome that requires systemic or immunosuppressive agents.
- Active infections requiring antibiotics, physician monitoring or recurrent fevers (\>38.0 ̊C) associated with a clinical diagnosis of active infection.
- Patient who has a history of seizures, central nervous system abnormalities, mental disorders, and heart disease.
- Patient who has a history of pleural effusion, pulmonary embolism, and intestinal obstruction.
- Treatment with any systemic anticancer therapies for locally advanced or metastatic within 4 weeks or 6 half-lives of prior anticancer therapy, whichever is shorter, prior to initiation of study treatment.
- Previous treated with GM103 or other oncolytic viruses.
- Radiation therapy within 2 weeks prior to enrollment.
- Use of the antiviral agents within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatment
- Patients who have received a live vaccine within 30 days of study enrollment.
- Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the...
- Participation of any other clinical trials within 4 weeks prior to first administration of study treatment.
- Administration of an investigational drug in the 28 days before the first dose of study treatment.
- Has an ejection fraction (EF) of 50% or less, based on a multigated acquisition (MUGA) scan or echocardiogram (ECHO).
- Major surgery within 4 weeks prior to enrollment.
- Inability or unwillingness to follow study procedures including drug administration.
- Any serious medical condition or abnormality in clinical laboratory tests
The study team makes the final eligibility decision.
Where it's taking place
- Goyang-si, Gyeonggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goyang-si, Gyeonggi-do, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.