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Metastatic NeoplasmPhase 1NCT03871348

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

A Phase 1 study testing SAR441000 and Cemiplimab REGN2810 in people with Metastatic Neoplasm, run by Sanofi at 19 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Primary Objectives: Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Neoplasm
What is being tested?
SAR441000 and Cemiplimab REGN2810
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
19 sitesin 6 countries
Study dates
3 Jan 2019to 21 Feb 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

  • At least 18 years of age
  • Advanced solid tumors including lymphomas for which no standard alternative therapy is available (escalation phase).
  • Advanced melanoma (Stage IIIB-C or Stage IV, anti-PD-1/PD-L1 treated or not) or anti-PD-1/PD-L1 not treated advanced Head and Neck Squamous Cell Cancer or anti-PD-1/PD-L1 not treated Advanced Cutaneous Squamous Cell Cancer where no other alternative treatment option exists (expansion phases).
  • Minimum 3 lesions enrollment.
  • Injectable disease (i.e., suitable for direct intratumoral injection based on the dose level volume of each cohort and cumulative lesion size; according to the investigator's judgement).
  • A lesion amenable for additional tumor biopsy.
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  • Patients with measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
  • Life expectancy more than 3 months.
  • Willingness to provide mandatory tumor biopsy.
  • Male and female patients who agree to use effective contraceptive methods.
  • Signed informed consent.

Who cannot join

  • Eastern Cooperative Oncology Group (ECOG) performance score >1.
  • Significant and uncontrolled concomitant illness that would adversely affect the patient's participation in the study.
  • Any prior organ transplantation.
  • History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected basal or squamous-cell skin cancer or carcinoma, in situ of cervix or other local tumors considered cured by local treatment.
  • History of unresolved viral hepatitis; systemic immune suppression including acquired immunodeficiency syndrome (AIDS) related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
  • Prior splenectomy.
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  • New and progressive brain lesions.
  • Poor bone marrow reserve resulting in low blood cell count.
  • Poor liver and kidney functions, abnormal coagulation tests.
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
  • Maintenance therapy with prednisolone >7.5 mg/day orally or equivalent during the study.
  • Non-resolution of any prior treatment related toxicity to Grade <2, except alopecia, vitiligo, fatigue and hypothyroidism controlled with replacement therapies.
  • Moderate to severe immune related adverse event to prior immune-modulating agents within 90 days prior to the first study treatment.
  • Central nervous system lymphoma.
  • Prior allogeneic hematopoietic stem cell transplantation (HSCT) for patients with lymphoma.
  • Autologous HSCT less than 90 days prior to initiation of study intervention.
  • 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

19 sites in 6 countries.

19 sites in 6 countries

Germany5 sites

  • Investigational Site Number : 2760005

    Hamburg, 20246

  • Investigational Site Number : 2760004

    Heidelberg, 69120

  • Investigational Site Number : 2760001

    Mainz, 55131

  • Investigational Site Number : 2760003

    Mannheim, 68167

  • Investigational Site Number : 2760006

    Tübingen, 72076

Other trials in Germany

United States3 sites

  • Dana-Farber Cancer Institute- Site Number : 8400003

    Boston, Massachusetts, 02215

  • Cleveland Clinic - Cleveland- Site Number : 8400007

    Cleveland, Ohio, 44195

  • The University of Texas MD Anderson Cancer Center- Site Number : 8400002

    Houston, Texas, 77030

Other trials in United States

Belgium3 sites

  • Investigational Site Number : 0560001

    Brussels, 1200

  • Investigational Site Number : 0560003

    Ghent, 9000

  • Investigational Site Number : 0560002

    Leuven, 3000

Other trials in Belgium

France3 sites

  • Investigational Site Number : 2500004

    Marseille, 13885

  • Investigational Site Number : 2500002

    Paris, 75010

  • Investigational Site Number : 2500001

    Villejuif, 94805

Other trials in France

Spain3 sites

  • Investigational Site Number : 7240004

    Barcelona, Catalunya [Cataluña], 08036

  • Investigational Site Number : 7240001

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240002

    Valencia, 46014

Other trials in Spain

Netherlands2 sites

  • Investigational Site Number : 5280002

    Nijmegen, 6525 GA

  • Investigational Site Number : 5280001

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

Official title: A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Primary Objectives:

  • Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options.
  • Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.
Read more

Secondary Objectives:

  • To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab.
  • To assess the immunogenicity of SAR441000.
  • To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab.
  • To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000.
  • To determine the recommended dose of SAR441000 for the expansion phase.
Read the detailed description

The expected duration of treatment for patients who benefit from study intervention may vary, based on progression date. Median expected duration of study per patient is estimated as 9 months in monotherapy and 12 months in combination therapy.

The maximum treatment duration for non-progressive patients is up to 2 years.

Being tested
SAR441000, Cemiplimab REGN2810
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR441000Drug

    Pharmaceutical form: concentrate for solution for injection

    Route of administration: intratumoral

  • Cemiplimab REGN2810Drug

    Pharmaceutical form: solution for injection

    Route of administration: intravenous

Study groups in NCT03871348
Study groupRoleWhat they receive
SAR441000 Dose Escalation PhaseExperimentalSAR441000 will be administered as intratumoral injection as monotherapy in patients with solid tumors over a 28-day cycle
Receives: Drug: SAR441000
SAR441000 + cemiplimab - Dose Escalation PhaseExperimentalSAR441000 will be administered as intratumoral injection in patients with solid tumors in combination with cemiplimab over a 21-day cycle
Receives: Drug: SAR441000; Drug: Cemiplimab REGN2810
SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 failureExperimentalSAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced melanoma who have failed anti-PD-1/PD-L1 therapy. Treatment is administered over a 21-day cycle
Receives: Drug: SAR441000; Drug: Cemiplimab REGN2810
SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 naiveExperimentalSAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve melanoma over a 21-day cycle
Receives: Drug: SAR441000; Drug: Cemiplimab REGN2810
SAR441000 + cemiplimab Expansion CSCC, anti-PD-1 naiveExperimentalSAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve Cutaneous Squamous Cell Carcinoma (CSCC) over a 21-day cycle
Receives: Drug: SAR441000; Drug: Cemiplimab REGN2810
SAR441000 + cemiplimab Expansion HNSCC, anti-PD-1 naiveExperimentalSAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve Head and Neck Squamous Cell Cancer (HNSCC) over a 21-day cycle
Receives: Drug: SAR441000; Drug: Cemiplimab REGN2810

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Monotherapy)

    Incidence of DLTs at Cycle 1 (SAR441000 monotherapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression

    Measured: Cycle 1; Cycle = 28 days for monotherapy

  2. For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Combination therapy)

    Incidence of DLTs during period from Cycle 1 Day 1 to Cycle 2 Day 8 (SAR441000 + cemiplimab combination therapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using NCI-CTCAE version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression

    Measured: Cycle 1 Day 1 to Cycle 2 Day 8; Cycle = 21 days for combination therapy; overall assessment = 28 days

  3. For dose escalation: Maximum tolerated dose (MTD) of SAR441000 (Monotherapy)

    MTD of SAR441000 as monotherapy, determined during Cycle 1 of dose escalation phase

    Measured: End of Dose Escalation phase (ie, End of Cycle 1 for last patient); Cycle = 28 days for monotherapy

  4. For dose escalation: Maximum tolerated dose (MTD) of SAR441000 (Combination therapy)

    MTD of SAR441000, in combination with cemiplimab, determined during period from Cycle 1 Day 1 to Cycle 2 Day 8 in dose escalation phase

    Measured: End of Dose Escalation Phase (ie, End of Cycle 1 Day 1 to Cycle 2 Day 8 for last patient); Cycle = 21 days for combination; overall assesment = 28 days

  5. Adverse Events

    Incidence of Treatment Emergent Adverse Events (TEAE) during dose escalation phase

    Measured: Up to end of treatment (Estimated median duration=12 months)

  6. For Expansion: Objective Response Rate (ORR)

    Assessment of overall response rate using standard imaging and RECIST 1.1 criteria

    Measured: Estimated median duration = 12 months

Secondary outcomes (15)

  1. Assessment of Pharmacokinetic (PK) parameter for SAR441000 (Cmax) (Monotherapy)

    Maximum plasma concentration (Cmax) of SAR4410000 as monotherapy observed over the dosing interval

    Measured: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 28 days for monotherapy

  2. Assessment of Pharmacokinetic (PK) parameter for SAR441000 (Cmax) (Combination therapy)

    Maximum plasma concentration (Cmax) of SAR4410000 in combination with cemiplimab observed over the dosing interval

    Measured: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 21 days for combination therapy

  3. Assessment of PK parameter for SAR441000 (AUC) (Monotherapy)

    Area under the plasma concentration versus time curve (AUC) of SAR441000 as monotherapy over the dosing interval

    Measured: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 28 days for monotherapy

  4. Assessment of PK parameter for SAR441000 (AUC) (Combination therapy)

    Area under the plasma concentration versus time curve (AUC) of SAR441000 in combination with cemiplimab over the dosing interval

    Measured: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 21 days for combination therapy

  5. Assessment of PK parameter (Ctrough) for SAR441000

    Trough Plasma Concentration (Ctrough) of SAR441000 as monotherapy and in combination with cemiplimab. It is defined as plasma concentration observed just before treatment administration during repeated dosing

    Measured: Baseline to End of Treatment (Estimated median duration of 12 months)

  6. Assessment of PK parameter for cemiplimab (Cmax)

    Maximum plasma concentration of cemiplimab in combination with SAR441000, observed over the dosing interval

    Measured: Cycle 1; Cycle duration is 21 days

  7. Assessment of PK parameter of cemiplimab (AUC)

    Area under the plasma concentration versus time curve of cemiplimab in combination with SAR441000 over the dosing interval

    Measured: Cycle 1; Cycle duration is 21 days

  8. Assessment of PK parameter for cemiplimab (Ctrough)

    Trough plasma concentration of cemiplimab in combination with SAR441000, observed just before treatment administration during repeated dosing

    Measured: Baseline to End of Treatment (Estimated median duration of 12 months)

  9. Immunogenicity of SAR441000 and cemiplimab

    Incidence of anti-drug antibody (ADA) positive patients for immunogenicity

    Measured: Baseline to End of Study (Estimated median duration of 12 months)

  10. DCR

    Disease Control Rate (DCR) with SAR441000 in combination with cemiplimab. DCR is sum of Complete Response + Partial Response + Stable Disease

    Measured: Baseline to End of Study (Estimated median duration of 12 months)

  11. DoR

    Duration of Response (DoR) with SAR441000 in combination with cemiplimab. DoR is time from initial response to the first documented tumor progression

    Measured: Baseline to End of Study (Estimated median duration of 12 months)

  12. Progression Free Survival (PFS)

    Time from first drug administration to the first documented tumor progression or death from any cause, whichever comes first

    Measured: Baseline to End of Study (Estimated median duration of 12 months)

  13. Incidence of Treatment Emergent Adverse Events (TEAE) during dose expansion phase

    Incidence of Adverse Events (AE)/ Serious AE (SAE) / Laboratory abnormalities considered to be adverse events

    Measured: Baseline to End of Treatment (Estimated median duration of 12 months)

  14. Recommended dose of SAR441000 for expansion phase (Combination therapy)

    SAR441000 dose for administration in combination with cemiplimab selected for expansion phase based on MTD/MAD by the Bayesian model, the overall safety, activity and PK/PDy data

    Measured: End of Dose Escalation Phase (ie, End of Cycle 1 Day 1 to Cycle 2 Day 8 for last patient); Cycle = 21 days for combination; overall assesment = 28 days

  15. For Dose Expansion: Objective Response Rate (ORR)

    Assessment of overall response rate using standard imaging by RECIST 1.1 and iRECIST criteria

    Measured: Estimated median duration of 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2019
  2. Study start3 Jan 2019
  3. Primary completion25 Jul 2022
  4. Study completion21 Feb 2024

Why it stopped: Sponsor terminated the study for non-safety reasons

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03871348
Sponsor's protocol ID
TED15297
Other IDs
U1111-1205-1176, 2017-004766-94, 2017
Status last verified
Sep 2025
First submitted
24 Jan 2019
Last updated
10 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

  • Bechter O, Loquai C, Champiat S, Baurain JF, Grob JJ, Utikal J, Rottey S, Berrocal A, Hassel JC, Arance A, Sanmamed MF, Boers-Sonderen M, Gastman B, Gebhardt C, Delafontaine B, Sahin U, Tureci O, Brueck P, Abbadessa G, Marpadga R, Lee H, Yang Y, Buday B, Di Genova G, Wang H, Xia B, Lee JS, Lebbe C. A Phase I, First-in-Human, Dose-Escalation, Expansion Trial of Cytokine-Encoding Synthetic mRNA Mixture Alone or with Cemiplimab in Advanced Solid Tumors. Clin Cancer Res. 2025 Jun 13;31(12):2358-2369. doi: 10.1158/1078-0432.CCR-24-1983.

    PubMed 40152791

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR441000 and Cemiplimab REGN2810 in people with Metastatic Neoplasm, run by Sanofi at 19 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 11 inclusion and 17 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 10 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 19 sites in Germany, United States, Belgium, France, 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 was stopped early (reason given: Sponsor terminated the study for non-safety reasons). 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?

For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Monotherapy) (time frame: Cycle 1; Cycle = 28 days for monotherapy). The study lists 6 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 NCT03871348, 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 10 Sep 2025.

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