Plasma Cell MyelomaPhase 1NCT04000282
First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing SAR442085 in people with Plasma Cell Myeloma, run by Sanofi at 12 sites in 6 countries.
Trial summary
Primary Objectives: Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B Dose Expansion Part B: To assess… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- SAR442085
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 19 Aug 2019to 4 Sep 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
- Healthy volunteers accepted
- 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.
- Participant has given voluntary written informed consent.
- Participant has been previousy diagnosed with multiple myeloma based on standard criteria.
- Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards. (3) Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards.
- Part B and the last cohort(s) of Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid. (3) Prior therapy has not included an anti-CD38 monoclonal antibody.
- Participant has myeloma disease progression on or after last therapy.
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- Participant must have measurable disease as defined as at least one of the following:
- Serum M protein ≥0.5 g/dL (≥5 g/L)
- Urine M protein ≥200 mg/24 hours
- Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum
- FLC ratio (<0.26 or >1.65).
- A male participant must agree to use contraception during the intervention period and for at least 150 days after the last dose of study drug and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP)
- A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 150 days after the last dose of study intervention.
Who cannot join
- Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, superficial bladder carcinoma or low risk prostate cancer.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score >2.
- Participant has a history of Chronic obstructive pulmonary disease (COPD) or asthma.
- Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline (exception: alopecia).
- Participant has congestive heart failure (New York Heart Association) Grade ≥II; cardiac myopathy, 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).
- Participant has had acute myocardial infarction within 6 months before first dose of study medication.
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- Participant has ongoing sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥3.
- Participant 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.
- Known acquired immunodeficiency syndrome (AIDS) or related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or to have active hepatitis A, B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA), or C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen) infection.
- Participant has positive Coombs test at baseline.
- 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
12 sites in 6 countries.
12 sites in 6 countries
United States5 sites
Dana Farber Cancer Institute Site Number : 8400003
Boston, Massachusetts, 02115
UNC Chapel Hill Site Number : 8400006
Chapel Hill, North Carolina, 27599
City of Hope Site Number : 8400002
Duarte, California, 91010
Froedtert Hospital & Medical College of Wisconsin Site Number : 8400004
Milwaukee, Wisconsin, 53226
Mayo Clinic of Rochester Site Number : 8400005
Rochester, Minnesota, 55905
Czechia3 sites
Investigational Site Number : 2030002
Brno, 62500
Investigational Site Number : 2030003
Ostrava - Poruba, 70852
Investigational Site Number : 2030001
Prague, 12808
About this study
Official title: An Open-label, First-in-human, Single Agent, Dose-escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Primary Objectives:
- Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B
- Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM
Read more
Secondary Objectives:
- To characterize the safety profile of SAR442085
- To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent
- To evaluate the potential immunogenicity of SAR442085
- To assess preliminary evidence of antitumor activity in the Dose Escalation Part A
Read the detailed description
Patient will continue to receive study medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason why investigator considers it appropriate to discontinue study medication. Once permanently discontinued, study medication cannot be restarted at later timepoint.
- Conditions
- Plasma Cell Myeloma
- Being tested
- SAR442085
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR442085Drug
Pharmaceutical form:Sterile lyophilized powder for reconstitution for infusion Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAR442085 dose escalation | Experimental | SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration. Receives: Drug: SAR442085 |
| Part B: SAR442085 dose expansion | Experimental | SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration. Receives: Drug: SAR442085 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) of SAR442085 (Part A)
MTD is defined as the dose level 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: At the end of Cycle 1 (each cycle is approximately 28 days)
Recommended Phase 2 dose (RP2D) (Part A)
RP2D is defined as the dose selected for the further single agent testing - including in Phase 1 expansion part B.
Measured: At the end of Cycle 1 (each cycle is approximately 28 days)
Overall response rate (Part B)
Overall response rate (ORR): is defined as the proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), using the International Myeloma Working Group (IMWG) criteria.
Measured: approximately 6 months after the last patient has started treatment in Part B (approx. 2 years)
Secondary outcomes (7)
Treatment-emergent adverse events (AEs)/serious adverse events (SAE) (Both Part A and B)
Number of participants with Treatment-Emergent Adverse events (TEAEs) from baseline to End of Study.
Measured: From baseline to end of treatment + 30 days (approx. 2 years)
PK parameters of SAR442085: Cmax (Both Part A and B)
Maximum plasma concentration observed (Cmax).
Measured: Cycle 1 Day 1 to Day 28
PK parameters of SAR442085: Tmax (Both Part A and B)
First time to reach Cmax (tmax).
Measured: Cycle 1 Day 1 to Day 28
PK parameters of SAR442085: AUC (Both Part A and B)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC).
Measured: Cycle 1 Day 1 to Day 28
Anti-drug antibody (ADA) against SAR442085 (Both Part A and B)
Number of participants with ADA against SAR442085.
Measured: Cycle 1, 2, 3, 6 and 9 (each cycle is approximately 28 days)
Progression-free survival (Part B)
Progression-free survival (PFS) is defined as the time interval from the date of enrollment to the date of documented tumor progression as per IMWG or death (due to any cause), whichever comes first.
Measured: approximately 12 months after the last patient has started treatment in Part B (approx. 2 years)
Duration of response (Part B)
Duration of response (DOR) is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as per IMWG or death from any cause, whichever occurs first.
Measured: approximately 12 months after the last patient has started treatment in Part B (approx. 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start19 Aug 2019
- Primary completion29 Aug 2022
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasma Cell MyelomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT04000282
- Sponsor's protocol ID
- TED16132
- Other IDs
- U1111-1223-4410, 2019-001018-40, 2019
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2019
- Last updated
- 12 Sep 2025
- 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
Publications
Kapoor P, Nathwani N, Jelinek T, Pour L, Perrot A, Dimopoulos MA, Huang SY, Spicka I, Chhabra S, Lichtman E, Mateos MV, Kanagavel D, Zhao L, Guillemin-Paveau H, Mace S, van de Velde H, Richardson PG. An open-label, first-in-human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma. Eur J Haematol. 2024 Nov;113(5):593-605. doi: 10.1111/ejh.14270. Epub 2024 Jul 12.
PubMed 38993150
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. 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 and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
- ClinicalTrials.gov ID
- NCT04000282
- Acronym / sponsor ID
- TED16132
- Conditions
- Plasma Cell Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 27 Jun 2019 (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 Objectives:
- Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B
- Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM
Secondary Objectives:
- To characterize the safety profile of SAR442085
- To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent
- To evaluate the potential immunogenicity of SAR442085
- To assess preliminary evidence of antitumor activity in the Dose Escalation Part A
Detailed description
Patient will continue to receive study medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason why investigator considers it appropriate to discontinue study medication. Once permanently discontinued, study medication cannot be restarted at later timepoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: SAR442085 dose escalation | Experimental | Drug: SAR442085SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration. |
| Part B: SAR442085 dose expansion | Experimental | Drug: SAR442085SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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.
- Participant has given voluntary written informed consent.
- Participant has been previousy diagnosed with multiple myeloma based on standard criteria.
- Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards. (3) Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards.
- Part B and the last cohort(s) of Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid. (3) Prior therapy has not included an anti-CD38 monoclonal antibody.
Key exclusion criteria (11 listed)
- Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, superficial bladder carcinoma or low risk prostate cancer.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score >2.
- Participant has a history of Chronic obstructive pulmonary disease (COPD) or asthma.
- Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline (exception: alopecia).
- Participant has congestive heart failure (New York Heart Association) Grade ≥II; cardiac myopathy, 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).
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 |
|---|---|---|
| SAR442085Pharmaceutical form:Sterile lyophilized powder for reconstitution for infusion Route of administration: intravenous | Drug | Part A: SAR442085 dose escalation, Part B: SAR442085 dose expansion |
Primary outcome
The maximum tolerated dose (MTD) of SAR442085 (Part A)
Time frame: At the end of Cycle 1 (each cycle is approximately 28 days)
MTD is defined as the dose level 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%)
Recommended Phase 2 dose (RP2D) (Part A)
Time frame: At the end of Cycle 1 (each cycle is approximately 28 days)
RP2D is defined as the dose selected for the further single agent testing - including in Phase 1 expansion part B.
Overall response rate (Part B)
Time frame: approximately 6 months after the last patient has started treatment in Part B (approx. 2 years)
Overall response rate (ORR): is defined as the proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), using the International Myeloma Working Group (IMWG) criteria.
7 secondary outcomes
Treatment-emergent adverse events (AEs)/serious adverse events (SAE) (Both Part A and B)
Time frame: From baseline to end of treatment + 30 days (approx. 2 years)
PK parameters of SAR442085: Cmax (Both Part A and B)
Time frame: Cycle 1 Day 1 to Day 28
PK parameters of SAR442085: Tmax (Both Part A and B)
Time frame: Cycle 1 Day 1 to Day 28
PK parameters of SAR442085: AUC (Both Part A and B)
Time frame: Cycle 1 Day 1 to Day 28
Anti-drug antibody (ADA) against SAR442085 (Both Part A and B)
Time frame: Cycle 1, 2, 3, 6 and 9 (each cycle is approximately 28 days)
Progression-free survival (Part B)
Time frame: approximately 12 months after the last patient has started treatment in Part B (approx. 2 years)
Duration of response (Part B)
Time frame: approximately 12 months after the last patient has started treatment in Part B (approx. 2 years)
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 12 Sep 2025.
- Results publication: PubMed 38993150Kapoor P, Nathwani N, Jelinek T, Pour L, Perrot A, Dimopoulos MA, Huang SY, Spicka I, Chhabra S, Lichtman E, Mateos MV, Kanagavel D, Zhao L, Guillemin-Paveau H, Mace S, van de Velde H, Richardson PG. An open-label, first-in-human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma. Eur J Haematol. 2024 Nov;113(5):593-605. doi: 10.1111/ejh.14270. Epub 2024 Jul 12.
- TED16132 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
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR442085 in people with Plasma Cell Myeloma, run by Sanofi at 12 sites in 6 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 15 inclusion and 11 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Czechia, France, Greece, Spain and 1 more country. 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?
The maximum tolerated dose (MTD) of SAR442085 (Part A) (time frame: At the end of Cycle 1 (each cycle is approximately 28 days)). 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?
On the ClinicalTrials.gov record for NCT04000282, which also lists 1 linked publication.
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 12 Sep 2025.