Neoplasm MalignantPhase 1NCT04401020
First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
A Phase 1 study testing SAR442257 in people with Neoplasm Malignant, run by Sanofi at 16 sites in 5 countries.
Trial summary
Primary Objective: To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D) Secondary Objectives: To… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- SAR442257
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 24 Jul 2020to 11 May 2026
- 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
- Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent.
- Life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- RRMM patients:
- must have received at least 3 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory agent (IMiD), and anti-CD38 mAb;
- and must be refractory to anti-CD38 antibody (eg, daratumumab or isatuximab), characterized by progression within 60 days of the last dose of anti-CD38, regardless of which line it was given; and must be either relapsed or refractory to all established therapies with known clinical benefit in RRMM where approved and available, or are intolerant to those established therapies; based upon investigator's clinical judgement.
- and must not be candidates for regimens known to provide clinical benefit based upon investigator's clinical judgement.
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- Patients with RRMM must have measurable disease as per the following:
- Serum M protein ≥0.5 g/dL (≥5 g/L), or
- Urine M protein ≥200 mg/24 hours, or
- Serum free light chain (FLC) assay: involved FLC assay ≥10 mg/dL and an abnormal serum FLC ratio (<0.26 or >1.65).
- Patients with RR-NHL must be relapsed or refractory to all established therapies with known clinical benefit where approved and available, or are intolerant to those established therapies; based upon investigator's clinical judgement.
- Patients with RR-NHL must have measurable disease of at least one lesion ≥1.5 cm as documented by computed tomography (CT) scan, including the following subtype of disease:
- Diffuse large B-cell lymphoma (DLBCL).
- HGBCL with MYC and/or BCL2 and/or BCL6 rearrangement or HGBCL NOS,
- transformed follicular lymphoma (tFL),
- follicular lymphoma (FL),
- mantle cell lymphoma (MCL),
- marginal zone lymphoma (MZL),
- lymphoplasmacytic lymphoma,
- small lymphocytic lymphoma (SLL). Patients with RR-NHL subtype T cell lymphoma (TCL) including the following subtype of disease: Nodal peripheral TCL including angio-immunoblastic TCL (AITL), anaplastic large cell lymphoma (ALCL), adult T cell leukemia-lymphoma, and peripheral TCL NOS (not otherwise specified). Peripheral TCL of the innate immune system: breast implant ALCL, extranodal NK/TCL, enteropathy associated TCL, monomorphic epitheliotropic intestinal TCL, and hepatosplenic TCL. histopathologically confirmed mycosis fungoides or Sézary syndrome (cutaneous T cell lymphoma [CTCL] stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (ie, refractory) as determined by the Investigator.
- Patients with lymphoma must have availability of lymphoma tissue for biomarker testing: either archived tissue or a fresh biopsy as a part of screening. On-treatment biopsy (Cycle 2 or beyond) is also expected if disease location is in a superficial lymph node. For post-CAR-T patients a fresh LN biopsy is expected if in a superficial node. For these patients tissue materials should be made available for analysis during the study. Excisional biopsy or resected tissue is required if clinically feasible; otherwise, core needle biopsy is acceptable. Fine needle aspirates are not acceptable.
- Patients with lymphoma must have a ≥50% left ventricular ejection fraction (LVEF) and no pericardial effusion, as measured by echocardiogram (ECHO).
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, except for basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, superficial bladder carcinoma or low risk prostate cancer.
- Amyloidosis, chronic lymphocytic leukemia and prolymphocytic leukemia. Known central nervous system (CNS) involvement by myeloma, lymphoma or other CNS disease such as neurodegenerative condition or CNS movement disorder.
- Has congestive heart failure (New York Heart Association) Grade ≥II; cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method >480 msec (Grade ≥2). Acute myocardial infarction within 6 months before start of study treatment.
- Has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.
- Clinically-not controlled chronic or ongoing infectious disease requiring treatment at the time of first dose or within the 14 days before first dose.
- Active hepatitis A, B, and C as defined below: active hepatitis A (defined as positive IgM), active hepatitis B (defined as either positive hepatitis B surface antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay, and hepatitis B core antibodies), or C infection (defined as a known positive hepatitis C antibody result and known quantitative hepatitis C [HCV] ribonucleic acid [RNA] results greater than the lower limits of detection of the assay).
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- Known positivity for Human Immunodeficiency Virus (HIV). Unresolved toxicities from prior anticancer therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 1 or to levels dictated in the eligibility criteria with the exception of Grade 1 peripheral neuropathy, alopecia or toxicities from prior anticancer therapy that are considered irreversible (defined as having been present and stable for >4 weeks) which may be allowed if they are not otherwise described in the exclusion criteria.
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Spain6 sites
Investigational Site Number : 7240003
Badalona, Catalunya [Cataluña], 08916
Investigational Site Number : 7240006
Madrid, Madrid, Comunidad de, 28027
Investigational Site Number : 7240007
Madrid, 28041
Investigational Site Number : 7240001
Pamplona, Navarre, 31008
Investigational Site Number : 7240005
Santander, Cantabria, 39008
Investigational Site Number : 7240004
Valencia, 46026
United States3 sites
City of Hope Site Number : 8400001
Duarte, California, 91010
University of Miami - Sylvester Comprehensive Cancer Center Site Number : 8400005
Miami, Florida, 33136
Mayo Clinic of Rochester Site Number : 8400003
Rochester, Minnesota, 55905
Czechia3 sites
Investigational Site Number : 2030003
Brno, 62500
Investigational Site Number : 2030001
Ostrava - Poruba, 70852
Investigational Site Number : 2030002
Prague, 12808
Norway2 sites
Investigational Site Number : 5780001
Oslo, 0440
Investigational Site Number : 5780101
Oslo, 0450
South Korea2 sites
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 03080
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 06351
About this study
Official title: An Open-label, First-in-human, Single Agent, Dose Escalation Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442257 in Patients With Relapsed and Refractory Multiple Myeloma and Relapsed and Refractory Non-Hodgkin Lymphoma
Primary Objective:
To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D)
Secondary Objectives:
- To characterize the safety profile of SAR442257
- To characterize the pharmacokinetics (PK) profile of SAR442257
- To assess preliminary evidence of antitumor activity
Read the detailed description
Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.
- Conditions
- Neoplasm Malignant
- Being tested
- SAR442257
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR442257Drug
Pharmaceutical form: Sterile powder for reconstitution Route of administration: Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | SAR442257 will be given intravenously with lead-in doses (LID) in the first-week, followed by once weekly until week 4 (Cycle 1) and once weekly for each subsequent cycle(s). Receives: Drug: SAR442257 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine maximum tolerated dose (MTD)
MTD: defined as the highest dose level (DL) with highest probability of Investigational Medicinal Product (IMP)-related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (>33%)
Measured: Baseline to estimated 4 weeks
Determine recommended Phase 2 dose (RP2D)
RP2D: defined as the dose selected for the further single agent testing in the future study
Measured: Baseline to estimated 4 months
Secondary outcomes (6)
Number of participants with AEs/SAEs/AESI
Incidence of treatment-emergent adverse events (AEs)/serious adverse events (SAEs)/ adverse events of special interest (AESIs) and laboratory abnormalities
Measured: Baseline to 30 days after end of treatment
Assessment of pharmacokinetic (PK) parameter: Cmax
Maximum concentration observed (Cmax)
Measured: through study completion (estimated 16 months)
Assessment of PK parameter: Ctrough
Concentration observed just before treatment administration during repeated dosing (Ctrough)
Measured: through study completion (estimated 16 months)
Assessment of PK parameter: AUC0-τ
Area under the concentration versus time curve during a dosing interval (T) (AUC0-τ)
Measured: up to 4 weeks
Overall response rate for RRMM
Overall response rate will be assessed using the International Myeloma Working Group (IMWG) 2016 criteria for patients with RRMM
Measured: Baseline to 6 months
Overall response rate for RR-NHL
Overall response rate will be assessed using the Response evaluation criteria in lymphoma (RECIL) 2017 criteria for patients with RR-NHL
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start24 Jul 2020
- Primary completion2 Mar 2024
- Study completion11 May 2026
Why it stopped: Sponsor decision based on limited clinical benefit observed in both Multiple Myeloma and Non-Hodgkin Lymphoma cohorts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401020
- Sponsor's protocol ID
- TED16364
- Other IDs
- U1111-1244-2511, 2019-003390-26, 2019
- Status last verified
- Sep 2026
- First submitted
- 12 May 2020
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, First-in-human, Single Agent, Dose Escalation Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442257 in Patients With Relapsed and Refractory Multiple Myeloma and Relapsed and Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04401020
- Acronym / sponsor ID
- TED16364
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on limited clinical benefit observed in both Multiple Myeloma and Non-Hodgkin Lymphoma cohorts
- Enrolment
- 47 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 26 May 2020 (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.
Primary Objective:
To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D)
Secondary Objectives:
- To characterize the safety profile of SAR442257
- To characterize the pharmacokinetics (PK) profile of SAR442257
- To assess preliminary evidence of antitumor activity
Detailed description
Study duration per participant is 2 months to estimated 16 months. Cycle lengths in this study are 27 days in Cycle 1 and 28 days for subsequent cycles as determined by totality of data collected thus far including PK/Pharmacodynamics (PD), safety and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: SAR442257SAR442257 will be given intravenously with lead-in doses (LID) in the first-week, followed by once weekly until week 4 (Cycle 1) and once weekly for each subsequent cycle(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent.
- Life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- must have received at least 3 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory agent (IMiD), and anti-CD38 mAb;
- and must be refractory to anti-CD38 antibody (eg, daratumumab or isatuximab), characterized by progression within 60 days of the last dose of anti-CD38, regardless of which line it was given; and must be either relapsed or refractory to all established therapies with known clinical benefit in RRMM where approved and available, or are intolerant to those established therapies; based upon investigator's clinical judgement.
- and must not be candidates for regimens known to provide clinical benefit based upon investigator's clinical judgement.
Key exclusion criteria (10 listed)
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, except for basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, superficial bladder carcinoma or low risk prostate cancer.
- Amyloidosis, chronic lymphocytic leukemia and prolymphocytic leukemia. Known central nervous system (CNS) involvement by myeloma, lymphoma or other CNS disease such as neurodegenerative condition or CNS movement disorder.
- Has congestive heart failure (New York Heart Association) Grade ≥II; cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method >480 msec (Grade ≥2). Acute myocardial infarction within 6 months before start of study treatment.
- Has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.
- Clinically-not controlled chronic or ongoing infectious disease requiring treatment at the time of first dose or within the 14 days before first dose.
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 |
|---|---|---|
| SAR442257Pharmaceutical form: Sterile powder for reconstitution Route of administration: Intravenous infusion | Drug | Dose escalation |
Primary outcome
Determine maximum tolerated dose (MTD)
Time frame: Baseline to estimated 4 weeks
MTD: defined as the highest dose level (DL) with highest probability of Investigational Medicinal Product (IMP)-related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (>33%)
Determine recommended Phase 2 dose (RP2D)
Time frame: Baseline to estimated 4 months
RP2D: defined as the dose selected for the further single agent testing in the future study
6 secondary outcomes
Number of participants with AEs/SAEs/AESI
Time frame: Baseline to 30 days after end of treatment
Assessment of pharmacokinetic (PK) parameter: Cmax
Time frame: through study completion (estimated 16 months)
Assessment of PK parameter: Ctrough
Time frame: through study completion (estimated 16 months)
Assessment of PK parameter: AUC0-τ
Time frame: up to 4 weeks
Overall response rate for RRMM
Time frame: Baseline to 6 months
Overall response rate for RR-NHL
Time frame: Baseline to 6 months
Results and safety
The study was stopped early (reason given: Sponsor decision based on limited clinical benefit observed in both Multiple Myeloma and Non-Hodgkin Lymphoma cohorts). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- TED16364 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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 Sciences & Operations study director
Sanofi
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR442257 in people with Neoplasm Malignant, run by Sanofi at 16 sites in 5 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 23 inclusion and 10 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, United States, Czechia, Norway, 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 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: Sponsor decision based on limited clinical benefit observed in both Multiple Myeloma and Non-Hodgkin Lymphoma cohorts). 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?
Determine maximum tolerated dose (MTD) (time frame: Baseline to estimated 4 weeks). 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 29 Sep 2026.