Relapsed/Refractory Multiple MyelomaPhase 1NCT03309111
Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
A Phase 1 study testing ISB 1342 in people with Relapsed/Refractory Multiple Myeloma, run by Ichnos Sciences SA at 20 sites in 2 countries.
Trial summary
The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- ISB 1342
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 25 Oct 2017to 15 Dec 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
- Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1 or less (for France).
- Adequate hematologic, renal, and hepatic functions
- Seronegative for hepatitis B antigen; positive hepatitis B tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled.
- Seronegative for hepatitis C antibody; if positive, then further test for the presence of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen tests are negative, then the subject can be enrolled.
- Oxygen saturation level ≥92% on room air.
- Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion at Screening
Who cannot join
- Active central nervous system involvement
- Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
- Active plasma cell leukemia
- Active infectious disease
- Clinically significant cardiovascular and respiratory conditions
- History of HIV infection
- Subjects requiring prohibited concomitant medications
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
France11 sites
CHU Hôpital Henri Mondor
Créteil, 94010
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille, 59000
L'Institut Paoli - Calmettes
Marseille, 13009
CHU de Nantes - Hôtel-Dieu
Nantes, Cedex, 44093
Hôpital Saint-Antoine
Paris, 75012
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
Pessac, Cedex, 33604
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Cedex, 69495
CHU de Poitiers
Poitiers, Cedex, 86021
CHU de Rennes - Hôpital Pontchaillou
Rennes, Cedex, 35033
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, Cedex
CHRU de Tours - Hôpital Bretonneau
Tours, Cedex, 37044
United States9 sites
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Duke Clinical Research Institute
Durham, North Carolina, 72205
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Tennessee Oncology
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai Beth Israel
New York, New York, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Phase 1, First-in-Human, Multicenter, Open-Label, Two-Part Dose-Escalation and Cohort Expansion Study of Single-Agent ISB 1342 in Subjects With Previously Treated Multiple Myeloma
The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.
Read the detailed description
This study is an open-label, multi-center, Phase 1 study of ISB 1342 in subjects with relapsed/refractory multiple myeloma refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs), and daratumumab. There will be a dose escalation phase (Part 1) and dose expansion phase (Part 2). In Part 1 of the study, subjects will be treated at escalating dose levels. Once the recommended part 2 dose (RP2D) of ISB 1342 is declared in Part 1, the expansion phase (Part 2) will be initiated at the RP2D.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- ISB 1342
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISB 1342Biological
ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion or subcutaneous injection (SC)
| Study group | Role | What they receive |
|---|---|---|
| ISB 1342 | Experimental | Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met Receives: Biological: ISB 1342 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)
Measured: 28 days
Proportion of subjects with an investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 2)
Measured: 28 days
Secondary outcomes (16)
Number of subjects with adverse events based on frequency and severity as assessed by common terminology criteria for adverse events (CTCAE) v5.0 (Part 1 and Part 2)
Measured: up to 30 days post last dose
Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2)
Measured: 28 days
Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2)
Measured: 28 days
Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 (Part 1 and Part 2)
Measured: 28 days
Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 (Part 1 and Part 2)
Measured: 28 days
Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2)
Measured: 28 days
Percent incidence of neutralizing antibody formation from positive anti-drug antibody (ADA) samples assessed from baseline until end of treatment (EOT) (Part 1 and Part 2)
Measured: 28 days
Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2)
Measured: 28 days
Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2)
Measured: 28 days
Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2)
Measured: 28 days
Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2)
Measured: 28 days
Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2)
Measured: 28 days
Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2)
Measured: 28 days
Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2)
Measured: 28 days
Efficacy of ISB 1342 (overall survival [OS]) (Part 2)
Measured: Time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months.
Proportion of subjects with investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 1)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start25 Oct 2017
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ichnos Sciences SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309111
- Sponsor's protocol ID
- ISB 1342-101
- Other IDs
- 2016-005253-20, 2016
- Status last verified
- Jun 2024
- First submitted
- 4 Oct 2017
- Last updated
- 13 Jun 2024
- Results posted
- No
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Multicenter, Open-Label, Two-Part Dose-Escalation and Cohort Expansion Study of Single-Agent ISB 1342 in Subjects With Previously Treated Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03309111
- Acronym / sponsor ID
- ISB 1342-101
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ichnos Sciences SAIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 13 Oct 2017 (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 assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.
Detailed description
This study is an open-label, multi-center, Phase 1 study of ISB 1342 in subjects with relapsed/refractory multiple myeloma refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs), and daratumumab. There will be a dose escalation phase (Part 1) and dose expansion phase (Part 2). In Part 1 of the study, subjects will be treated at escalating dose levels. Once the recommended part 2 dose (RP2D) of ISB 1342 is declared in Part 1, the expansion phase (Part 2) will be initiated at the RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISB 1342 | Experimental | Biological: ISB 1342Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1 or less (for France).
- Adequate hematologic, renal, and hepatic functions
- Seronegative for hepatitis B antigen; positive hepatitis B tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled.
- Seronegative for hepatitis C antibody; if positive, then further test for the presence of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen tests are negative, then the subject can be enrolled.
Key exclusion criteria (7 listed)
- Active central nervous system involvement
- Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
- Active plasma cell leukemia
- Active infectious disease
- Clinically significant cardiovascular and respiratory conditions
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 |
|---|---|---|
| ISB 1342ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion or subcutaneous injection (SC) | Biological | ISB 1342 |
Primary outcome
Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)
Time frame: 28 days
Proportion of subjects with an investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 2)
Time frame: 28 days
16 secondary outcomes
Number of subjects with adverse events based on frequency and severity as assessed by common terminology criteria for adverse events (CTCAE) v5.0 (Part 1 and Part 2)
Time frame: up to 30 days post last dose
Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2)
Time frame: 28 days
Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2)
Time frame: 28 days
Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 (Part 1 and Part 2)
Time frame: 28 days
Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 (Part 1 and Part 2)
Time frame: 28 days
Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2)
Time frame: 28 days
Percent incidence of neutralizing antibody formation from positive anti-drug antibody (ADA) samples assessed from baseline until end of treatment (EOT) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (overall survival [OS]) (Part 2)
Time frame: Time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months.
Proportion of subjects with investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 1)
Time frame: 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 13 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Relapsed/Refractory Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ISB 1342 in people with Relapsed/Refractory Multiple Myeloma, run by Ichnos Sciences SA at 20 sites in 2 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 7 inclusion and 7 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, 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?
Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1) (time frame: 28 days). The study lists 2 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 13 Jun 2024.