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S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers

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ClinicalTrials.gov Identifier: NCT05162755
Recruitment Status : Recruiting
First Posted : December 17, 2021
Last Update Posted : May 3, 2022
Sponsor:
Collaborator:
ADIR, a Servier Group company
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Brief Summary:
The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: S095029 Drug: S95029 and Sym021 Drug: S095029 and Sym021 and anti-HER2 therapy Drug: Dose expansion 2b: S095029 and Sym021 and futuximab/modotuximab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers
Actual Study Start Date : October 15, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : July 2025

Arm Intervention/treatment
Experimental: Dose escalation 1a: S95029 Drug: S095029
S095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated.

Experimental: Dose escalation 1b: S95029 and Sym021 Drug: S95029 and Sym021
Sym021 will be administered at a fixed dose of 200mg. S095029 will be administered via IV infusion every 2 weeks. Once the RP2D dose of S95029 in combination with Sym21 is defined, dose expansion will begin.

Experimental: Dose expansion 2a: S095029 and Sym021 and anti-HER2 therapy Drug: S095029 and Sym021 and anti-HER2 therapy
Patients will be administered with S095029, Sym021 and anti-HER2 therapy.

Experimental: Dose expansion 2b: S095029 and Sym021 and futuximab/modotuximab Drug: Dose expansion 2b: S095029 and Sym021 and futuximab/modotuximab
Patients will be administered with S095029, Sym021 and futuximab/modotuximab.




Primary Outcome Measures :
  1. Adverse Events (AEs) (Dose escalation part) [ Time Frame: Through study completion, up to 2 years ]
    Incidence, severity, and relationship of AEs

  2. Incidence of dose limiting toxicities (DLTs) (Dose escalation part) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    DLTs observed during a 28-day period

  3. Assessment of antitumor activity using RECIST v1.1 (Dose expansion part) [ Time Frame: Through study completion, up to 2 years ]
    Objective Response Rate


Secondary Outcome Measures :
  1. Objective Response Rate (Dose escalation part) [ Time Frame: Through study completion, up to 2 years ]
  2. Clinical Benefit Rate (CBR) (Dose escalation and dose expansion parts) [ Time Frame: Through study completion, up to 2 years ]
    Assessment based on complete response, partial response and stable disease ≥ 6 months

  3. Duration of response (DOR) (Dose escalation and dose expansion parts) [ Time Frame: Through study completion, up to 2 years ]
  4. Progression Free Survival (PFS) (Dose escalation and dose expansion parts) [ Time Frame: Through study completion, up to 2 years ]
  5. Overall Survival (OS) (Dose escalation and dose expansion parts) [ Time Frame: Through study completion, up to 2 years ]


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

Dose escalation part:

Inclusion Criteria:

  • Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies
  • Patients with a malignancy not amenable to surgical intervention
  • Patients with measurable disease and progression radiologically assessed
  • Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment.
  • Patients with available archived tumor biopsy specimens or agree to mandatory biopsy
  • Estimated life expectancy ≥ 12 weeks
  • Adequate haematological function
  • Adequate renal function
  • Adequate hepatic function

Exclusion Criteria:

  • Pregnant and lactating women
  • Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery
  • Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration
  • Active Hepatitis B Virus infection
  • Carriers of HIV antibodies
  • Patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration
  • History of organ transplantation
  • History of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion
  • History of cirrhosis
  • History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition
  • Treatment with systemic immunosuppressive therapy
  • Active autoimmune disease
  • Administration of a live vaccine within 28 days prior to inclusion

Cohort expansion part 2a:

Inclusion Criteria:

  • Histologically proven metastatic HER2+ gastric cancer
  • Have received treatment with first line of standard therapy and eligible for second line

Exclusion Criteria:

Same criteria as for Part 1 with the addition of:

- Left ventricle ejection fraction < 50%

Cohort expansion part 2b:

Inclusion Criteria:

  • Patients with confirmed adenocarcinoma of metastatic colorectal cancer
  • Patients must have a wild-type gene status for KRAS (exons 2, 3, 4), NRAS (exons 2, 3, 4) and BRAF (absence of V600E mutation) in a tumor biopsy collected at time of screening.

Exclusion Criteria:

Same criteria as for dose escalation part with the addition of:

  • Patients with a significant gastrointestinal abnormality
  • Patients with skin rash of Grade > 1 from prior anti-EGFR

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): NCT05162755


Contacts
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Contact: Institut de Recherches Internationales Servier, Clinical Studies Department +33 1 55 72 43 66 scientificinformation@servier.com

Locations
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United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
The START Center for Cancer Care Recruiting
San Antonio, Texas, United States, 78229
Canada
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Canada
Sponsors and Collaborators
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
Investigators
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Principal Investigator: Nehal Lakhani MD, MD, PhD Director of Clinical Research START Midwest
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT05162755    
Other Study ID Numbers: CL1-95029-001
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: https://clinicaltrials.servier.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
Adults
Advanced solid tumors
Sym21
Futuximab/modotuximab
Triplet combination
Anti-EGFR
Anti-HER2
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases