A Phase Ia/Ib, 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

Study Identifier:
CL1-95029-001
CT.gov Identifier:
NCT05162755
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

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.

To evaluate safety, tolerability, preliminary efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of S095029 as monotherapy or combined with Sym021 in patients with advanced solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arm Intervention/treatment Experimental: Dose escalation 1a: S95029Drug: 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 Sym021Drug: 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. SITC 2024: Monotherapy regimen included 2doses of S095029 Q2W (one 28-day cycle) followed by single agent Sym021 (Q2W).
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    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
    • Same criteria as for Part 1 with the addition of:
    • - Left ventricle ejection fraction < 50%

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruitment on Hold
    Condition(s) Treated at Site
    Solid Tumor