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Dose Escalation and Expansion Study of SAR444200 in Adult Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05450562
Recruitment Status : Recruiting
First Posted : July 8, 2022
Last Update Posted : October 18, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:
This is a single group, treatment, Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

Condition or disease Intervention/treatment Phase
Neoplasm Biological: SAR444200 Biological: Cemiplimab Phase 1 Phase 2

Detailed Description:

Treatment Period: enrolled participants will receive continuous treatment until disease progression (PD), unacceptable adverse event (AE), or other permanent discontinuation criteria.

The End of Treatment visit will occur 30 days ±7 days from last IMP administration or prior to initiation of further therapy, whichever occurs first.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR444200-based Regimen in Participants With Advanced Solid Tumors.
Actual Study Start Date : September 20, 2022
Estimated Primary Completion Date : May 11, 2029
Estimated Study Completion Date : May 11, 2029

Arm Intervention/treatment
Experimental: SAR444200 - Dose Escalation Phase (Part 1A)
SAR444200 will be administered as intravenous injection as monotherapy in patients with GPC3+ solid tumors over a 21-day cycle
Biological: SAR444200
Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion

Experimental: SAR444200 - Dose Expansion Phase (Part 2A)
SAR444200 will be administered as intravenous injection in patients with GPC3+ NSCLC over a 21-day cycle
Biological: SAR444200
Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion

Experimental: SAR444200 and Cemiplimab combination therapy - Dose Escalation Phase (Part 1B)
SAR444200 in combination with cemiplimab will be administered as intravenous injection in patients with GPC3+ solid tumors over a 21-day cycle
Biological: SAR444200
Sterile lyophilized powder for solution for infusion Route of administration: intravenous (IV) infusion

Biological: Cemiplimab
concentrate for solution for infusion Route of administration: intravenous (IV) infusion
Other Name: Libtayo® REGN2810




Primary Outcome Measures :
  1. Part 1A and 1B: Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: For Part 1A: from the Cycle 1, Day 1 up to Day 21 For Part 1B: from Cycle 2 Day 1 up to Day 21 ]
    Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  2. Part 1A and 1B: Number of participants with Adverse Events (AEs) [ Time Frame: the time from the first dose of study interventions up to 30 days after last dose of study interventions ]
    Incidence of treatment emergent AEs and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  3. Part 2A: Objective Response Rate (ORR) [ Time Frame: From baseline to the end of expansion study (up to 2 years) ]
    ORR defined as the proportion of participants who have a complete response (CR) or partial response (PR) determined per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)


Secondary Outcome Measures :
  1. Part 1A and 1B: Objective Response Rate (ORR) [ Time Frame: Baseline to end of dose escalation study (up to 2 years) ]
    ORR defined as the proportion of participants who have a complete response (CR) or partial response (PR) determined per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  2. All parts: Duration of response (DoR) [ Time Frame: Baseline to end of study (up to 2 years) ]
    DoR defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death from any cause, whichever occurs first determined per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  3. All parts: Assessment of PK parameters: Cmax [ Time Frame: Cycle 1 Day 1 to Day 21 ]
    Maximum plasma concentration observed

  4. All parts:Assessment of PK parameters: AUC0-T [ Time Frame: Cycle 1 Day 1to Day 21 ]
    Area under the concentration versus time curve calculated using the trapezoidal method during a dosing interval (T)

  5. All parts: Assessment of PK parameters: Tmax [ Time Frame: Cycle 1 Day 1to Day 21 ]
    Time to reach Cmax

  6. All parts: Incidence of anti-drug antibodies (ADAs) to SAR444200 [ Time Frame: From the first dose of Cycle to 30 days after last dose of study interventions. Cycle duration is 21 days ]
    Incidence of patients with anti-drug antibodies to SAR444200

  7. All parts: Concentrations of cytokines [ Time Frame: From the first dose of Cycle to 30 days after last dose of study interventions. Cycle duration is 21 days ]
  8. Part 2A: Progression Free Survival (PFS) [ Time Frame: From baseline to end of expansion study (up to 2 years) ]
    PFS, defined as the time from the date of first IMP administration to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 (or death due to any cause, whichever occurs first)

  9. Part 2A: Number of participants with Adverse Events (AEs) [ Time Frame: The time from the first dose of study interventions up to 30 days after last dose of study interventions. ]
    Incidence of treatment emergent AEs and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer diagnosis for participants for Part 1A and Part 1B:

    1. Metastatic and/or unresectable HCC diagnosed by histology and/or cytology, or diagnosed clinically by the American Association for the Study of Liver Diseases (AASLD) criteria for participants with liver cirrhosis (participants without liver cirrhosis must be diagnosed histologically) OR Other histology/cytology proven advanced and/or metastatic non-HCC solid tumors
    2. Not amenable to available standard of care: participants must have experienced disease progression on/after standard of care, or no acceptable standard curative or palliative treatments exist (or are no longer effective), according to Investigator judgement, or the patient declines standard of care therapy.
  • Cancer diagnosis for participants for Part 2A: Metastatic NSCLC diagnosed by histology and/or cytology not amenable to available standard of care
  • Additional for Part 2A: At least 1 measurable lesion per RECIST 1.1 criteria
  • For all participants:

    1. Positive GPC3 expression on tumor tissue as determined locally or centrally
    2. Capable of giving signed informed consent

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≥2.
  • Predicted life expectancy ≤3 months.
  • For participants with HCC: Child Pugh Class B or C liver score within 14 days of initiation of IMP. Participants with Child Pugh Class B-7 score are allowed for Part 1A.
  • Known active brain metastases or leptomeningeal metastases.
  • History of allogenic or solid organ transplant
  • Treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity
  • Significant cardiovascular disease within 3 months prior to initiation of IMP, uncontrolled arrhythmia requiring medication, or unstable angina.
  • Ongoing AEs caused by any prior anti-cancer therapy >Grade 2
  • Known uncontrolled human immunodeficiency virus (HIV), hepatitis B infection, or known untreated current hepatitis C infection
  • Known second malignancy either progressing or requiring active treatment within the last year.
  • For combination therapy: Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
  • Receipt of a live-virus vaccination within 28 days of planned treatment start.
  • For Part 2A, has received prior GPC3 targeted anticancer treatment.
  • Current pneumonitis or interstitial lung disease, or history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.

NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05450562


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

Locations
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United States, Rhode Island
Lifespan-Site Number:8400002 Recruiting
Providence, Rhode Island, United States, 02903
Canada
Investigational Site Number :1240001 Recruiting
Quebec, Canada, G1R 2J6
Korea, Republic of
Investigational Site Number :4100002 Recruiting
Seoul, Seoul-teukbyeolsi, Korea, Republic of, 05505
Investigational Site Number :4100001 Recruiting
Seoul, Seoul-teukbyeolsi, Korea, Republic of, 135-710
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT05450562    
Other Study ID Numbers: TCD17240
U1111-1264-3207 ( Registry Identifier: ICTRP )
2021-006623-17 ( EudraCT Number )
First Posted: July 8, 2022    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents