Solid TumorPhase 1NCT05702424
Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer
A Phase 1 study testing IGM-7354 in people with Solid Tumor, run by IGM Biosciences, Inc. at 5 sites in United States.
Trial summary
This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors. The study design consists of a dose-escalation stage and dose-expansion stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IGM-7354
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Jan 2023to 31 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age > 18 years at time of signing ICF
- ECOG Performance Status of 0 or 1
- Histologic or cytologic documentation of incurable, locally advanced or metastatic solid tumors for which standard therapies are not available, are no longer effective, are not tolerated, or have been declined by the participant
- Participants with either measurable or evaluable disease
- Adequate organ function
- At least 2 weeks prior to Day 1 or 5 half-lives, whichever is shorter, must have elapsed from the use of anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy
- Participants must be willing to have pre-treatment and on-treatment tumor biopsies for biomarker evaluation
Who cannot join
- Inability to comply with study and follow-up procedures
- Prior IL-15, IL-2, synthetic IL-2, or IL-2v based therapy
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Palliative radiation to bone metastases within 2 weeks prior to Day 1
- Major surgical procedure within 4 weeks prior to Day 1
- Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible.
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- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Diagnosis of immunodeficiency
- Current Grade >1 toxicity from prior therapy. Participants with current Grade 2 chronic toxicities that are well-controlled by medications may be enrolled after discussion with medical monitor
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolina Biooncology Institute
Huntersville, North Carolina, 28078
Yale University
New Haven, Connecticut, 06520
Oklahoma University
Norman, Oklahoma, 73019
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Florida Cancer Specialists & Research Institute
Sarasota, Florida, 34232
About this study
Official title: An Open-Label, Multicenter, Phase 1 Study of IGM-7354 in Adult Participants With Relapsed and/or Refractory Cancer
This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors. The study design consists of a dose-escalation stage and dose-expansion stage. Study participation will consist of a 28-day screening period, a treatment period, and a safety follow-up period 90-days after the last dose.
Read the detailed description
Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-7354 safety and tolerability in patients with relapsed and/or refractory solid tumors. The dose expansion serial biopsy cohort will assess the intra-tumoral PD changes related to the activity of IGM-7354.
IGM-7354 will be administered intravenously (IV).
- Conditions
- Solid Tumor
- Being tested
- IGM-7354
- Keywords
- Relapsed and/or Refractory, Metastatic Cancer, Advanced Tumors, Incurable
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGM-7354Drug
IGM-7354 is a PD-L1-targeted cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects
| Study group | Role | What they receive |
|---|---|---|
| IGM-7354 Single-Agent Dose Escalation | Experimental | IGM-7354 will be administered intravenously as a single agent. Receives: Drug: IGM-7354 |
| IGM-7354 Single-Agent Dose Expansion Serial Biopsy | Experimental | IGM-7354 will be administered intravenously as a single agent and patients will undergo pre-treatment and on-treatment biopsies. Receives: Drug: IGM-7354 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD
Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Secondary outcomes (8)
Area Under the Curve (AUC) of IGM-7354
Area Under the Curve (AUC) of IGM-7354 as a single agent
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Clearance (CL) of IGM-7354
Clearance (CL) of IGM-7354 as a single agent
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Volume of distribution (V) of IGM-7354
Volume of distribution (V) of IGM-7354 as a single agent
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Maximum Plasma Concentration (Cmax) of IGM-7354
Maximum Plasma Concentration (Cmax) of IGM-7354 as a single agent
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigators
Measured: Study duration of approximately 29 months
Duration of Response (DoR)
For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented CR or PR to the first documented disease progression or death, whichever occurs first.
Measured: Study duration of approximately 29 months
Progression-Free Survival (PFS)
PFS is defined as the time from first dose to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
Measured: Study duration of approximately 29 months
Anti-drug antibodies (ADAs) of IGM-7354
Immunogenicity of IGM-7354
Measured: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start10 Jan 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- IGM Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, IGM Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702424
- Sponsor's protocol ID
- IGM-7354-001
- Status last verified
- Jul 2024
- First submitted
- 13 Jan 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1 Study of IGM-7354 in Adult Participants With Relapsed and/or Refractory Cancer
- ClinicalTrials.gov ID
- NCT05702424
- Acronym / sponsor ID
- IGM-7354-001
- Conditions
- Solid Tumor
- Keywords
- Relapsed and/or Refractory, Metastatic Cancer, Advanced Tumors, Incurable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- IGM Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 Jan 2023 (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.
This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors. The study design consists of a dose-escalation stage and dose-expansion stage. Study participation will consist of a 28-day screening period, a treatment period, and a safety follow-up period 90-days after the last dose.
Detailed description
Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-7354 safety and tolerability in patients with relapsed and/or refractory solid tumors. The dose expansion serial biopsy cohort will assess the intra-tumoral PD changes related to the activity of IGM-7354.
IGM-7354 will be administered intravenously (IV).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGM-7354 Single-Agent Dose Escalation | Experimental | Drug: IGM-7354IGM-7354 will be administered intravenously as a single agent. |
| IGM-7354 Single-Agent Dose Expansion Serial Biopsy | Experimental | Drug: IGM-7354IGM-7354 will be administered intravenously as a single agent and patients will undergo pre-treatment and on-treatment biopsies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years at time of signing ICF
- ECOG Performance Status of 0 or 1
- Histologic or cytologic documentation of incurable, locally advanced or metastatic solid tumors for which standard therapies are not available, are no longer effective, are not tolerated, or have been declined by the participant
- Participants with either measurable or evaluable disease
- Adequate organ function
Key exclusion criteria (9 listed)
- Inability to comply with study and follow-up procedures
- Prior IL-15, IL-2, synthetic IL-2, or IL-2v based therapy
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Palliative radiation to bone metastases within 2 weeks prior to Day 1
- Major surgical procedure within 4 weeks prior to Day 1
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 |
|---|---|---|
| IGM-7354IGM-7354 is a PD-L1-targeted cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects | Drug | IGM-7354 Single-Agent Dose Escalation, IGM-7354 Single-Agent Dose Expansion Serial Biopsy |
Primary outcome
To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0
8 secondary outcomes
Area Under the Curve (AUC) of IGM-7354
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Clearance (CL) of IGM-7354
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Volume of distribution (V) of IGM-7354
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Maximum Plasma Concentration (Cmax) of IGM-7354
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Objective Response Rate (ORR)
Time frame: Study duration of approximately 29 months
Duration of Response (DoR)
Time frame: Study duration of approximately 29 months
Progression-Free Survival (PFS)
Time frame: Study duration of approximately 29 months
Anti-drug antibodies (ADAs) of IGM-7354
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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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. This study is not recruiting at the moment.
Clinical Trials study director
IGM Biosciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IGM-7354 in people with Solid Tumor, run by IGM Biosciences, Inc. at 5 sites in United States.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD (time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)). 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 24 Jul 2024.