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

NCT04167137 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-03

Study results available
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Summary

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.

Conditions

Interventions

DRUG

SYNB1891

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.

DRUG

Atezolizumab

Atezolizumab was administered in accordance with its recommended dose and schedule (1200 mg IV Q3W).

Sponsors & Collaborators

  • IQVIA Biotech

    collaborator INDUSTRY

  • Synlogic

    lead INDUSTRY

Principal Investigators

  • Aoife Brennan, MB, BCh, BAO, MMSc · Synlogic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2021-12-09
Completion
2021-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167137 on ClinicalTrials.gov