Head and Neck CancerPhase 1/2NCT06265025
GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors
A Phase 1/2 study testing GM103 (Part A), GM103 (Part B) and GM103 and Pembrolizumab (Part C) in people with Head and Neck Cancer and Malignant Melanoma, run by GeneMedicine Co., Ltd. at 4 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Malignant Melanoma, Colorectal Cancer
- What is being tested?
- GM103 (Part A), GM103 (Part B) and GM103 and Pembrolizumab (Part C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 20 Feb 2024to 30 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (for measurable lesions) with computed tomography (CT) or magnetic resonance imaging (MRI).
- 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 (CT) or magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT); or clinical examination and which is suitable for repeated measurement.
- 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.
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- 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.
Who cannot join
- 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.
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- 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 ability of the patient to receive protocol therapy or interfere with the interpretation of study results.
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Not yet recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
WY Choi
- Not yet recruiting
Korea University Anam Hospital
Seoul, 02841
SH Lee
- Not yet recruiting
Hanyang University Seoul Hospital
Seoul, 04763
MS Chung
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
JY Lee
About this study
Official title: A Phase I/II, Open-label, Dose-escalation With Expansion Study of GM103 Via Intratumoral Injection, Alone and in Combination With Pembrolizumab in Adult Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors
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:
Read the detailed description
Part A, B
- Primary Objectives
- To determine the MTD and RP2D based on safety and tolerability of GM103 as monotherapy.
- To evaluate overall safety profile of GM103 as monotherapy.
- Secondary Objectives
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy.
Part C
- Primary Objectives
- To determine the MTD and RP2D based on safety and tolerability of GM103 in combination with pembrolizumab.
- To evaluate overall safety profile of GM103 in combination with pembrolizumab .
- Secondary Objectives
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab.
- Conditions
- Head and Neck Cancer, Malignant Melanoma, Colorectal Cancer, Renal Cell Carcinoma, Cervical Cancer, Breast Cancer
- Being tested
- GM103 (Part A), GM103 (Part B), GM103 and Pembrolizumab (Part C)
- Keywords
- Oncolytic Virus, OV, Solid tumor
- Medical subject headings
- Head and Neck Neoplasms, Melanoma, Colorectal Neoplasms, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM103 (Part A)Drug
dose escalation of GM103 as monotherapy, conducted in 12-24 patients. Part A will include a screening period of up to 28 days, a dose limiting toxicity (DLT) evaluation period of the first 2 cycles, and a treatment period from cycles 3-12 (each cycle will consist of 14 days [2 weeks]).
GM103 (Part B)Drug
dose expansion study of GM103 as monotherapy, conducted in up to 40 patients (a minimum of 20 patients per target disease [HNC, CRC]). Part B of the study will include a screening period of up to 28 days, and 1 to a maximum of 12 treatment cycles (each cycle will consist of 14 days [2 weeks]).
GM103 and Pembrolizumab (Part C)Drug
dose-escalation and dose-expansion of GM103 in combination with pembrolizumab, conducted in approximately 61 patients. Part C of the study will include a screening period of up to 28 days, a safety run-in period of 2 cycles (it consists of 2 cohorts and the first 1 cycle for the DLT assessment period of each cohort is included, each cycle will consist of 21 days [3 weeks]), and a dose expansion period from cycle 3 to a maximum of 12 treatment cycles (of 21 days [3 weeks]).
| Study group | Role | What they receive |
|---|---|---|
| Treatment (GM103): Part A_Dose escalation | Experimental | Multiple escalating dose levels of GM103
(1 x 10^11 vp, 3 x 10^11 vp, 1 x 10^12 vp, 3 x 10^12 vp) Receives: Drug: GM103 (Part A) |
| Treatment (GM103): Part B_Dose expansion | Experimental | Dose expansion study of GM103 as monotherapy
(GM103 RP2D for HNC, GM103 RP2D for CRC) Receives: Drug: GM103 (Part B) |
| Treatment (GM103 and pembrolizumab): Part C_Dose escalation and dose expansion | Experimental | Dose-escalation and dose-expansion of GM103 in combination with pembrolizumab
* Safety run in cohorts (GM103 1 dose level below RP2D + Pembrolizumab 200mg, GM103 RP2D + Pembrolizumab 200mg)
* Dose expansion (GM103 RP2D*+ Pembrolizumab 200mg for HNC, GM103 RP2D* + Pembrolizumab 200mg for CRC)
* *Recommended dose based on previous safety run in cohorts Receives: Drug: GM103 and Pembrolizumab (Part C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with DLTs by cohorts
To determine the MTD and RP2D based on safety and tolerability of GM103 as monotherapy (Parts A, B).
Measured: during the first 28 days of treatment
Percentage of patients with DLTs
To determine the MTD and RP2D based on safety and tolerability of GM103 in combination with pembrolizumab (Part C)
Measured: during the first 21 days of treatment
Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death
To evaluate overall safety profile of GM103 as monotherapy (Parts A, B) and in combination with pembrolizumab (Part C)
Measured: through study completion, and average 1 year
Secondary outcomes (5)
ORR
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy (Parts A and B)
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab (Part C)
Measured: through study completion, and average 1 year
DCR defined as the proportion of patients whose BOR was CR, PR and SD
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy (Parts A and B)
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab (Part C)
Measured: through study completion, an average of 1 year
Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy (Parts A and B)
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab (Part C)
Measured: through study completion, an average of 1 year
Incidence of GM103 detection
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy (Parts A and B)
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab (Part C)
Measured: every cycle, through study completion, an average of 1 year [up to 12 treatment cycles, Part A&B: each cycle will consist of 14 days(2 weeks) / Part C: each cycle will consist of 21 days(3 weeks)]
Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR)
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy (Parts A and B)
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab (Part C)
Measured: every 2 cycles after the first cycle, through study completion, an average of 1 year [up to 12 treatment cycles, Part A&B: each cycle will consist of 14 days(2 weeks) / Part C: each cycle will consist of 21 days(3 weeks)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Feb 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation and dose expansion
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneMedicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SH Lee, Principal investigator, Korea University Anam HospitalJY Lee, Principal investigator, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265025
- Sponsor's protocol ID
- GM103-CT-101
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Dose-escalation With Expansion Study of GM103 Via Intratumoral Injection, Alone and in Combination With Pembrolizumab in Adult Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06265025
- Acronym / sponsor ID
- GM103-CT-101
- Conditions
- Head and Neck Cancer, Malignant Melanoma, Colorectal Cancer, Renal Cell Carcinoma, Cervical Cancer, Breast Cancer
- Keywords
- Oncolytic Virus, OV, Solid tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- GeneMedicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Detailed description
Part A, B
- Primary Objectives
- To determine the MTD and RP2D based on safety and tolerability of GM103 as monotherapy.
- To evaluate overall safety profile of GM103 as monotherapy.
- Secondary Objectives
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy.
Part C
- Primary Objectives
- To determine the MTD and RP2D based on safety and tolerability of GM103 in combination with pembrolizumab.
- To evaluate overall safety profile of GM103 in combination with pembrolizumab .
- Secondary Objectives
- To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose escalation and dose expansion
| Arm | Type | Receives |
|---|---|---|
| Treatment (GM103): Part A_Dose escalation | Experimental | Drug: GM103 (Part A)Multiple escalating dose levels of GM103 (1 x 10^11 vp, 3 x 10^11 vp, 1 x 10^12 vp, 3 x 10^12 vp) |
| Treatment (GM103): Part B_Dose expansion | Experimental | Drug: GM103 (Part B)Dose expansion study of GM103 as monotherapy (GM103 RP2D for HNC, GM103 RP2D for CRC) |
| Treatment (GM103 and pembrolizumab): Part C_Dose escalation and dose expansion | Experimental | Drug: GM103 and Pembrolizumab (Part C)Dose-escalation and dose-expansion of GM103 in combination with pembrolizumab * Safety run in cohorts (GM103 1 dose level below RP2D + Pembrolizumab 200mg, GM103 RP2D + Pembrolizumab 200mg) * Dose expansion (GM103 RP2D*+ Pembrolizumab 200mg for HNC, GM103 RP2D* + Pembrolizumab 200mg for CRC) * *Recommended dose based on previous safety run in cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 (for measurable lesions) with computed tomography (CT) or magnetic resonance imaging (MRI).
- 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 (CT) or magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT); or clinical examination and which is suitable for repeated measurement.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM103 (Part A)dose escalation of GM103 as monotherapy, conducted in 12-24 patients. Part A will include a screening period of up to 28 days, a dose limiting toxicity (DLT) evaluation period of the first 2 cycles, and a treatment period from cycles 3-12 (each cycle will consist of 14 days [2 weeks]). | Drug | Treatment (GM103): Part A_Dose escalation |
| GM103 (Part B)dose expansion study of GM103 as monotherapy, conducted in up to 40 patients (a minimum of 20 patients per target disease [HNC, CRC]). Part B of the study will include a screening period of up to 28 days, and 1 to a maximum of 12 treatment cycles (each cycle will consist of 14 days [2 weeks]). | Drug | Treatment (GM103): Part B_Dose expansion |
| GM103 and Pembrolizumab (Part C)dose-escalation and dose-expansion of GM103 in combination with pembrolizumab, conducted in approximately 61 patients. Part C of the study will include a screening period of up to 28 days, a safety run-in period of 2 cycles (it consists of 2 cohorts and the first 1 cycle for the DLT assessment period of each cohort is included, each cycle will consist of 21 days [3 weeks]), and a dose expansion period from cycle 3 to a maximum of 12 treatment cycles (of 21 days [3 weeks]). | Drug | Treatment (GM103 and pembrolizumab): Part C_Dose escalation and dose expansion |
Primary outcome
Percentage of patients with DLTs by cohorts
Time frame: during the first 28 days of treatment
To determine the MTD and RP2D based on safety and tolerability of GM103 as monotherapy (Parts A, B).
Percentage of patients with DLTs
Time frame: during the first 21 days of treatment
To determine the MTD and RP2D based on safety and tolerability of GM103 in combination with pembrolizumab (Part C)
Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death
Time frame: through study completion, and average 1 year
To evaluate overall safety profile of GM103 as monotherapy (Parts A, B) and in combination with pembrolizumab (Part C)
5 secondary outcomes
ORR
Time frame: through study completion, and average 1 year
DCR defined as the proportion of patients whose BOR was CR, PR and SD
Time frame: through study completion, an average of 1 year
Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death
Time frame: through study completion, an average of 1 year
Incidence of GM103 detection
Time frame: every cycle, through study completion, an average of 1 year [up to 12 treatment cycles, Part A&B: each cycle will consist of 14 days(2 weeks) / Part C: each cycle will consist of 21 days(3 weeks)]
Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR)
Time frame: every 2 cycles after the first cycle, through study completion, an average of 1 year [up to 12 treatment cycles, Part A&B: each cycle will consist of 14 days(2 weeks) / Part C: each cycle will consist of 21 days(3 weeks)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SH Lee principal investigator
Korea University Anam Hospital
JY Lee principal investigator
Severance Hospital, Yonsei University Health System
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GM103 (Part A), GM103 (Part B) and GM103 and Pembrolizumab (Part C) in people with Head and Neck Cancer and Malignant Melanoma, run by GeneMedicine Co., Ltd. at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KyoungRyun Park (+82 2 6214 3247, krpark@gene-medicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with DLTs by cohorts (time frame: during the first 28 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.