For Healthcare Professionals

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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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  • Dose escalation part:
  • Inclusion Criteria:

    1. Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies
    2. Patients with a malignancy not amenable to surgical intervention
    3. Patients with measurable disease and progression radiologically assessed
    4. 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.
    5. Patients with available archived tumor biopsy specimens or agree to mandatory biopsy
    6. Estimated life expectancy ≥ 12 weeks
    7. Adequate haematological function
    8. Adequate renal function
    9. Adequate hepatic function

    Inclusion Criteria:

    Inclusion Criteria:

    EXCLUSION CRITERIA

    Exclusion Criteria:

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

    Cohort expansion part 2a:

    1. Histologically proven metastatic HER2+ gastric cancer
    2. 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:

    1. Patients with confirmed adenocarcinoma of metastatic colorectal cancer
    2. 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:

    1. Patients with a significant gastrointestinal abnormality
    2. Patients with skin rash of Grade > 1 from prior anti-EGFR
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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition

    Solid Tumor

    Age (in years)

    18+

    Phase

    Phase 1

    Participants needed

    40

    Est. Completion Date

    Feb 1, 2024

    Treatment type

    Interventional


    Sponsor

    Servier

    ClinicalTrials.gov identifier

    NCT05162755

    Study number

    CL1-95029-001

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