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

  • STATUS
    Recruiting
  • End date
    Mar 29, 2024
  • participants needed
    231
  • sponsor
    Sanofi
Updated on 13 May 2022
cancer
measurable disease
carcinoma
pd-l1

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.
  • 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.

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.

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.

Details
Condition Metastatic Neoplasm
Treatment Cemiplimab REGN2810, SAR441000
Clinical Study IdentifierNCT03871348
SponsorSanofi
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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
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