S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Shionogi
Study ID
NCT05101070
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • S-531011 — DRUG
    Administered by intravenous infusion
  • Pembrolizumab — DRUG
    Administered by intravenous infusion
  • Bevacizumab — DRUG
    Administered by intravenous infusion

Study Details

The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab. The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D with or without pembrolizumab. The primary objective of Parts D and E is to evaluate the antitumor activity of S-531011 at the RP2D in combination with bevacizumab with our without pembrolizumab.

Key Dates

Start date
May 30, 2022
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
282 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A-1: S-531011 Monotherapy
    Participants will receive escalating doses of S-531011 by intravenous infusion for up to approximately 12 months.
  • Experimental: Part A-2: S-531011 + Pembrolizumab
    Participants will receive escalating doses of S-531011 in combination with pembrolizumab by intravenous infusion for up to approximately 24 months.
  • Experimental: Part B: S-531011 Monotherapy
    Participants will receive S-531011 at the RP2D by intravenous infusion for up to approximately 12 months.
  • Experimental: Part C: S-531011 + Pembrolizumab
    Participants will receive S-531011 at the RP2D in combination with pembrolizumab by intravenous infusion for up to approximately 24 months.
  • Experimental: Part D: S-531011 + Bevacizumab
    Participants will receive S-531011 at the RP2D in combination with bevacizumab or bevacizumab biosimilar by intravenous infusion for up to approximately 24 months.
  • Experimental: Part E: S-531011 + Bevacizumab + Pembrolizumab
    Participants will receive S-531011 at the RP2D in combination with bevacizumab or bevacizumab biosimilar and pembrolizumab by intravenous infusion for up to approximately 24 months.

Primary Outcome Measure

Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Approximately 12 months (Part A-1); Approximately 24 months (Part A-2) ]

Central Contacts

  • Shionogi Clinical Trials Administrator Clinical Support Help Line
    800-849-9707
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Angeles Clinic and Research CenterLos AngelesCalifornia90025-
University of Florida HealthGainesvilleFlorida32610-
Henry Ford Health CenterDetroitMichigan48202-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Angeles Clinic and Research Center· Los Angeles, CAUniversity of Florida Health· Gainesville, FLHenry Ford Health Center· Detroit, MIFox Chase Cancer Center· Philadelphia, PAMD Anderson Cancer Center· Houston, TX

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