Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
invoX Pharma Limited
Study ID
NCT04096638
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • SB 11285 — DRUG
    SB 11285 2mg lyophilized powder for IV infusion
  • Atezolizumab — DRUG
    1680 mg every 4 weeks

Study Details

A Phase 1a/1b, multicenter, open-label, non-randomized, dose-escalation, and cohort expansion study to examine the DLTs, MTD, and RP2D of SB 11285 administered as an IV infusion in patients with advanced solid tumors.

Key Dates

Start date
Sep 23, 2019
Status verified
Mar 2024
Primary completion
Jul 16, 2024
Completion
Jul 16, 2024

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a: Monotherapy Dose Escalation
    SB 11285 weekly on Days 1, 8, 15 and 22 on repeated 28-day cycles in escalating doses
  • Experimental: Part 1b: PD-L1 Combination Dose Escalation
    SB 11285 weekly on Days 1, 8, 15 and 22 on repeated 28-day cycles in escalating doses plus 1680mg every 4 weeks (Q4W) atezolizumab
  • Experimental: Part 2: Combination Expansion Cohorts at RP2D (Cohort A)
    Cohort A: Patients with Melanoma After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.
  • Experimental: Part 2: Combination Expansion Cohorts at RP2D (Cohort B)
    Cohort B: Patients with HNSCC After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.
  • Experimental: Part 2: Combination Expansion Cohorts at RP2D (Cohort C)
    Cohort C: Patients with tumor types other then Cohort A and B (Naïve or relapsed refractory to anti PD-1/PD-L1) After determination of maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in SB 11285 plus atezolizumab combination the Part 2 with expansion cohorts will commence to further evaluate the RP2D.

Primary Outcome Measure

Part 1: Observation of DLT [ Time Frame: Cycle 1 (4 weeks) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Philadelphia, PA

By condition
Head and neck cancerMelanoma
By specialty
OncologyENTSkin cancerDermatology
By research site
Fox Chase Cancer Center· Philadelphia, PAUPMC Hillman Cancer Center· Pittsburgh, PA

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