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Trial record 1 of 1 for:    TCD17620
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A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05584670
Recruitment Status : Recruiting
First Posted : October 18, 2022
Last Update Posted : February 26, 2024
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy for participants aged at least 18 years with advanced unresectable or metastatic malignancies.

The study will include 2 parts:

A dose escalation Part 1: for finding the recommended dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW).

A multicohort dose expansion Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy (2 dose levels will be tested in at least 1 indication as applicable).

Approximately 240 participants will be enrolled to the study intervention:

For Part 1: approximately 75 participants, For Part 2: up to 30 participants will be enrolled in each cohort per dose level for a total of approximately 165.


Condition or disease Intervention/treatment Phase
Solid Tumor Drug: SAR445877 Phase 1 Phase 2

Detailed Description:

The duration of the study for a participant will include:

Screening Period: up to 28 days Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met.

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

The follow-up period will occur until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Sequential 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 SAR445877 Administered as Monotherapy in Adults With Advanced Solid Tumors
Actual Study Start Date : November 29, 2022
Estimated Primary Completion Date : January 19, 2027
Estimated Study Completion Date : March 15, 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: SAR445877 Escalation Phase (Part 1)
SAR445877 monotherapy will be administered intravenously in patients with solid tumors over a 14-day cycle.
 Drug: SAR445877
Concentrate for solution for infusion
Experimental: SAR445877 Expansion Phase: Cohort A (Part 2)
SAR445877 monotherapy will be administered intravenously (IV) in patients with non-small cell lung cancer (NSCLC).
 Drug: SAR445877
Concentrate for solution for infusion
Experimental: SAR445877 Expansion Phase: Cohort B (Part 2)
SAR445877 monotherapy will be administered intravenously in patients with hepatocellular carcinoma (HCC).
 Drug: SAR445877
Concentrate for solution for infusion
Experimental: SAR445877 Expansion Phase: Cohort C (Part 2)
Participants will receive SAR445877 monotherapy will be administered IV in patients with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).
 Drug: SAR445877
Concentrate for solution for infusion
Experimental: SAR445877 Expansion Phase: Cohort D (Part 2)
Participants will receive SAR445877 monotherapy will be administered IV in patients with immune infiltrated tumor type.
 Drug: SAR445877
Concentrate for solution for infusion


Outcome Measures
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Primary Outcome Measures :
  1. Dose escalation: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2 [ Time Frame: Cycles 1 & 2 - 14 day per cycle ]
    DLTs will be defined using NCI CTCAE version 5.0 or ASTCT criteria for CRS or immune effector cell-associated neurotoxicity syndrome (ICANS)

  2. Dose escalation: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) [ Time Frame: The time from the first dose of study interventions up to 30 days after last dose of study interventions ]
    Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading

  3. Dose expansion: Objective response rate (ORR) [ Time Frame: From baseline to the end of dose expansion (up to 2 years) ]
    Proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response (BOR) determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1


Secondary Outcome Measures :
  1. Dose escalation Objective response rate (ORR) [ Time Frame: From baseline to the end of dose escalation (up to 2 years) ]
    Proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response (BOR) determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  2. Dose escalation & expansion Duration of response (DoR) [ Time Frame: From baseline to the end of study (up to 2 years) ]
    DoR is defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) determined by Investigator per RECIST 1.1 or death from any cause, whichever occurs first

  3. Dose escalation & expansion Assessment of SAR445877 Cmax [ Time Frame: Cycle 1 Day 1 to Day 8 or Day 14 (cycle duration of 14 days) ]
    Maximum plasma concentration observed

  4. Dose escalation & expansion Assessment of SAR445877 AUC0-T [ Time Frame: Cycle 1 Day 1 to Day 8 or Day 14 (cycle duration of 14 days) ]
    Area under the concentration versus time curve calculated using the trapezoidal method during a dosing interval (T)

  5. Dose escalation & expansion Incidence of anti-drug antibodies (ADAs) to SAR445877 [ Time Frame: From the first dose of Cycle 1 to 30 days after last dose of study interventions (cycle duration of 14 days) ]
    Incidence of patients with anti-drug antibodies (ADAs) to SAR445877

  6. Time to response is defined as the time from the first administration of investigational medicinal product (IMP) to the first documented evidence of confirmed PR or CR determined by Investigator per RECIST 1.1 [ Time Frame: From baseline to end of dose expansion (up to 2 years) ]
    Time to response is defined as the time from the first administration of investigational medicinal product (IMP) to the first documented evidence of confirmed PR or CR determined by Investigator per RECIST 1.1

  7. Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST 1.1 [ Time Frame: From baseline to end of dose expansion (up to 2 years) ]
    Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST 1.1

  8. PFS is defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 or death from any cause, whichever occurs first [ Time Frame: From baseline to end of dose expansion (up to 2 years) ]
    PFS is defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 or death from any cause, whichever occurs first

  9. Number of participants with Adverse events (AE) [ Time Frame: The time from the first dose of study interventions up to 30 days after last dose of study interventions. ]
    Presence of adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading


Eligibility Criteria
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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:

Dose escalation Part 1

  • Participants with advanced unresectable or metastatic solid tumors for which, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant

Dose expansion Part 2

Cancer diagnosis:

  • Participants in Cohort A: Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
  • Participants in Cohort B: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients (patients without cirrhosis must have had histological confirmation of diagnosis).
  • Participants in Cohort C: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 & 3 gastro esophageal junction (GEJ) adenocarcinoma.
  • For participants in Cohort C: Disease with CPS scoring of <1 as determined at local laboratory with an Agency approved test (for the other cohorts: Disease with any CPS scoring. No need for CPS determination at local laboratory).
  • For participants in Cohort C: Participants must have MSI (metastatic microsatellite instability) or MMR (mismatch repair) status known or determined locally and must have non-MSI-H or proficient MMR (pMMR) disease to be eligible.
  • For participants in Cohort C: Participants with unknown HER2/neu status must have their HER2/neu status determined locally. Participants with HER2/neu negative are eligible. Participants with HER2/neu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible.

Measurable Disease:

  • At least 1 measurable lesion per RECIST 1.1 criteria

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- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part 1.
  • Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment.
  • Known active brain metastases or leptomeningeal metastases.
  • History of 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 or have not resolved to Grade ≤1.
  • Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine.
  • Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration.
  • Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events.
  • Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.
  • Organ transplant requiring immunosuppressive treatment.
  • Uncontrolled or active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency.

NOTE: Other Inclusion/Exclusion criteria may apply.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Contacts and Locations
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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): NCT05584670


Contacts
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Contact: Trial Transparency email recommended (Toll free for US & Canada) 800-633-1610 ext option 6 contact-us@sanofi.com

Locations
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United States, Kansas
University of Kansas Cancer Center Clinical Research Center (Fairway) Site Number : 8400008 Recruiting
Fairway, Kansas, United States, 66205-2528
Contact: Lisa Bogart    913-945-7552    CTNurseNav@kumc.edu   
Principal Investigator: Joaquina Baranda         
United States, New Jersey
John Theurer Cancer Center Site Number : 8400001 Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Suzanne Kosky    551-996-3986    suzanne.kosky@hmhn.org   
Principal Investigator: Martin Gutierrez         
United States, Rhode Island
Rhode Island Hospital Site Number : 8400004 Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kaitlyn Krar    401-444-4818    CKrar@Lifespan.org   
Principal Investigator: Khaldoun Almhanna         
United States, Texas
University of Texas MD Anderson Cancer Center Site Number : 8400005 Recruiting
Houston, Texas, United States, 77030-4000
Contact: Yali Yang    713-794-5555    anaing@mdanderson.org   
Principal Investigator: Aung Naing         
Israel
Hadassah Medical Center - PPDS_Investigational Site Number : 3760005 Recruiting
Jerusalem, Israel, 91120
Contact: Jonathan Cohen    972505172537    cohenjon@hadassah.org.il   
Principal Investigator: Jonathan Cohen         
Sheba Medical Center - PPDS_Investigational Site Number : 3760003 Not yet recruiting
Ramat Gan, Israel, 5262100
Contact: Tamar Beller    972545964434    Tamar.Beller@sheba.health.gov.il   
Principal Investigator: Tamar Beller         
Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis_Investigational Site Number : 5280001 Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Contact: Marloes van Dongen    31205129111    mg.v.dongen@nki.nl   
Principal Investigator: Marloes van Dongen         
Erasmus MC_Investigational Site Number : 5280003 Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Ferry Eskens    31107034897    f.eskens@erasmusmc.nl   
Principal Investigator: Ferry Eskens         
Spain
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON_Investigational Site Number : 7240007 Recruiting
Barcelona, Spain, 08035
Contact: Elena Garralda    34932746085    egarralda@vhio.net   
Principal Investigator: Elena Garralda         
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC_Investigational Site Number : 7240005 Recruiting
Madrid, Spain, 28050
Contact: Emiliano Calvo    34917567825    emiliano.calvo@startmadrid.com   
Principal Investigator: Emiliano Calvo         
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT05584670    
Other Study ID Numbers: TCD17620
U1111-1277-4827 ( Registry Identifier: ICTRP )
2022-001239-95 ( EudraCT Number )
First Posted: October 18, 2022    Key Record Dates
Last Update Posted: February 26, 2024
Last Verified: February 2024
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms