Multiple MyelomaPhase 1NCT05289492
Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing EOS884448, Iberdomide and Dexamethasone in people with Multiple Myeloma, run by iTeos Therapeutics at 13 sites in 4 countries.
Trial summary
This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- EOS884448, Iberdomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 1 May 2022to 29 Nov 2023
- 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
- All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
- All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).
- All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.
- All participants must have adequate organ function.
- Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.
Who cannot join
- All participants with non-secretory MM
- All participants with known auto-immune disease
- All participants with history of life-threatening toxicity related to prior immune therapy.
- All participants with active graft versus host disease after allogeneic stem cell transplantation.
- All participants with active, unstable cardiovascular function.
- All participants with active infection requiring systemic therapy.
- All participants with hypersensitivity to any of the treatments.
- All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
France5 sites
CHU Amiens
Amiens, 80054
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
APHP Hôpital Saint-Antoine
Paris, 75012
CHU de Poitiers
Poitiers, 86021
CHU Toulouse
Toulouse, 31059
United States4 sites
Banner MD Anderson
Gilbert, Arizona, 85234
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Eastern Connecticut Hematology & Oncology
Norwich, Connecticut, 06360
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Belgium3 sites
ZNA Cadix
Antwerp, 2020
Institut Jules Bordet
Brussels, 1070
Universitaire Ziekenhuizen KU Leuven
Leuven, 3000
About this study
Official title: Study of EOS884448 Alone, and in Combination with Iberdomide with or Without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma
This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).
- Conditions
- Multiple Myeloma
- Being tested
- EOS884448, Iberdomide, Dexamethasone
- Keywords
- Multiple Myeloma, EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, iberdomide, CELMoD, CC-220, EOS-448, Belrestotug
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS884448Drug
Also called EOS-448, GSK4428859A, Belrestotug
EOS884448 will be administered in arm A,B and C
IberdomideDrug
Also called CC-220
Iberdomide will be administered in arm B and C
DexamethasoneDrug
Dexamethasone will be administered in arm C
| Study group | Role | What they receive |
|---|---|---|
| A: Participants will receive EOS884448 | Experimental | EOS884448 will be administered Receives: Drug: EOS884448 |
| B: Participants will receive EOS884448 and iberdomide | Experimental | EOS884448 and iberdomide will be administered Receives: Drug: EOS884448; Drug: Iberdomide |
| C: Participants will receive EOS884448, iberdomide and dexamethasone | Experimental | EOS884448, iberdomide and dexamethasone will be administered Receives: Drug: EOS884448; Drug: Iberdomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
Measured: From first study treatment administration up to 120 days after the last dose
Number of participants with dose limiting toxicity (DLT)
Measured: From first study treatment administration up to 120 days after the last dose
Recommended Phase 2 dose (RP2D) of EOS884448 alone or in combinations with iberdomide with or without dexamethasone in participants with relapse/refractory multiple myeloma
Measured: up to 2 years
Number of participants with overall response (partial or better) as determined by IMWG criteria
Measured: up to 2 years
Secondary outcomes (5)
Progression-free-survival (PFS)
Measured: Until disease progression or death - Approximately 24 months
Duration of Response (DOR)
Measured: Until disease progression or death - Approximately 24 months
Time to Response (TTR)
Measured: Approximately 48 weeks
Maximum concentration (Cmax) of EOS884448 at each dose level
Measured: Approximately 48 weeks
Percentage of participants with anti-drug antibodies to EOS884448
Measured: Approximately 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 May 2022
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Why it stopped: Company operational decision. Decision to stop study is not due to safety or efficacy concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- iTeos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, GlaxoSmithKline, iTeos Belgium SA
- Responsible party
- Sponsor
- Investigators
- Iteos Clinical Trials, Study director, iTeos Belgium SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289492
- Sponsor's protocol ID
- TIG-007
- Status last verified
- Oct 2024
- First submitted
- 11 Mar 2022
- Last updated
- 26 Oct 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of EOS884448 Alone, and in Combination with Iberdomide with or Without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05289492
- Acronym / sponsor ID
- TIG-007
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, iberdomide, CELMoD, CC-220
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company operational decision. Decision to stop study is not due to safety or efficacy concerns
- Enrolment
- 16 participants (actual)
- Lead sponsor
- iTeos TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, GlaxoSmithKline, iTeos Belgium SA
- Study start
- 1 May 2022 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 21 Mar 2022 (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 is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Participants will receive EOS884448 | Experimental | Drug: EOS884448EOS884448 will be administered |
| B: Participants will receive EOS884448 and iberdomide | Experimental | Drug: EOS884448, Drug: IberdomideEOS884448 and iberdomide will be administered |
| C: Participants will receive EOS884448, iberdomide and dexamethasone | Experimental | Drug: EOS884448, Drug: Iberdomide, Drug: DexamethasoneEOS884448, iberdomide and dexamethasone will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
- All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).
- All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.
- All participants must have adequate organ function.
- Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.
Key exclusion criteria (8 listed)
- All participants with non-secretory MM
- All participants with known auto-immune disease
- All participants with history of life-threatening toxicity related to prior immune therapy.
- All participants with active graft versus host disease after allogeneic stem cell transplantation.
- All participants with active, unstable cardiovascular function.
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 |
|---|---|---|
| EOS884448Also: EOS-448, GSK4428859A, BelrestotugEOS884448 will be administered in arm A,B and C | Drug | A: Participants will receive EOS884448, B: Participants will receive EOS884448 and iberdomide, C: Participants will receive EOS884448, iberdomide and dexamethasone |
| IberdomideAlso: CC-220Iberdomide will be administered in arm B and C | Drug | B: Participants will receive EOS884448 and iberdomide, C: Participants will receive EOS884448, iberdomide and dexamethasone |
| DexamethasoneDexamethasone will be administered in arm C | Drug | C: Participants will receive EOS884448, iberdomide and dexamethasone |
Primary outcome
Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
Time frame: From first study treatment administration up to 120 days after the last dose
Number of participants with dose limiting toxicity (DLT)
Time frame: From first study treatment administration up to 120 days after the last dose
Recommended Phase 2 dose (RP2D) of EOS884448 alone or in combinations with iberdomide with or without dexamethasone in participants with relapse/refractory multiple myeloma
Time frame: up to 2 years
Number of participants with overall response (partial or better) as determined by IMWG criteria
Time frame: up to 2 years
5 secondary outcomes
Progression-free-survival (PFS)
Time frame: Until disease progression or death - Approximately 24 months
Duration of Response (DOR)
Time frame: Until disease progression or death - Approximately 24 months
Time to Response (TTR)
Time frame: Approximately 48 weeks
Maximum concentration (Cmax) of EOS884448 at each dose level
Time frame: Approximately 48 weeks
Percentage of participants with anti-drug antibodies to EOS884448
Time frame: Approximately 48 weeks
Results and safety
The study was stopped early (reason given: Company operational decision. Decision to stop study is not due to safety or efficacy concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
Iteos Clinical Trials study director
iTeos Belgium SA
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EOS884448, Iberdomide and Dexamethasone in people with Multiple Myeloma, run by iTeos Therapeutics at 13 sites in 4 countries.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, United States, Belgium, Spain. 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 was stopped early (reason given: Company operational decision. Decision to stop study is not due to safety or efficacy concerns). Results are not available in the source record.
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?
Number of participants with any adverse events (AEs) and serious adverse events (SAEs) (time frame: From first study treatment administration up to 120 days after the last dose). The study lists 4 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 26 Oct 2024.