Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Participants

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Synlogic
Study ID
NCT04167137
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • SYNB1891 — DRUG
    SYNB1891 was administered as an IT injection over a dose range of 1 x 10\^6 to 3 x 10\^8 live cells in Arm 1 and 1 x 10\^7 to 3 x 10\^7 in Arm 2.
  • Atezolizumab — DRUG
    Atezolizumab was administered in accordance with its recommended dose and schedule (1200 mg IV Q3W).

Study Details

This Phase 1, open-label, multicenter, 2-arm study was designed to evaluate SYNB1891 when administered either as monotherapy (Arm 1) or in combination with atezolizumab (Arm 2) in participants with advanced/metastatic solid tumors or lymphoma. The primary objective was to evaluate the safety and tolerability of study treatment, with a secondary objective of assessing preliminary tumor response to treatment and exploratory objectives of evaluating the pharmacokinetics/pharmacodynamics (PK/PD) of study treatment.

Key Dates

Start date
Dec 12, 2019
Status verified
Nov 2023
Primary completion
Dec 9, 2021
Completion
Dec 9, 2021

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: SYNB1891 Monotherapy
    SYNB1891 monotherapy was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles for up to 24 months/35 cycles. The starting dose of SYNB1891 in the first cohort was 1 × 10\^6 live cells and was increased in approximately 3-fold increments in subsequent cohorts.
  • Experimental: Arm 2: SYNB1891 in Combination with Atezolizumab
    SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles for up to 24 months/35 cycles. The dose of SYNB1891 in the first cohort was 1 × 10\^7 live cells and was increased in an approximately 3-fold increment to 3 × 10\^7 live cells in the second cohort. Atezolizumab was administered in accordance with its recommended dose and schedule (1200 mg IV Q3W) on Day 1 of each cycle for up to 24 months/35 cycles. On days when atezolizumab and SYNB1891 were both administered, SYNB1891 was administered first, followed by at least 1 hour of observation prior to the atezolizumab infusion.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicity [ Time Frame: 21 days (1 cycle) ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Colorado School of MedicineAuroraColorado80045-
Hackensack University John Theurer Cancer CenterHackensackNew Jersey07601-
Ohio State University College of MedicineColumbusOhio43210-
University of Pittsburgh Hillman Cancer CenterPittsburghPennsylvania15232-
Mary Crowley Cancer ResearchDallasTexas75230-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Aurora, CO

By research site
University of Colorado School of Medicine· Aurora, COHackensack University John Theurer Cancer Center· Hackensack, NJOhio State University College of Medicine· Columbus, OHUniversity of Pittsburgh Hillman Cancer Center· Pittsburgh, PAMary Crowley Cancer Research· Dallas, TXUniversity of Texas MD Anderson Cancer Center· Houston, TX

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