18 and older, any sex, with Metastatic Solid Neoplasm or Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose-limiting ToxicityPrimary· 21 days (1 cycle)
The following adverse events (AEs) were DLTs if they occurred in Cycle 1 and were assessed by the Investigator as related to treatment:
1. Grade (Gr) 4 nonhematologic toxicity (not laboratory)
2. Gr 4 hematologic toxicity ≥ 7 days, any Gr 4 thrombocytopenia, or Gr 3 thrombocytopenia with significant bleeding
3. Gr ≥ 3 nonhematologic toxicity (exceptions: Gr 3 fatigue ≤ 3 days; Gr 3 diarrhea, nausea, or vomiting without treatment; Gr 3 rash without treatment)
4. Gr 3/4 nonhematologic laboratory value for \> 1 week or resulting in significant medical intervention, hospitalization, or drug-induc
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
0
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
0
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
0
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
0
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
0
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
1
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
0
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
0
Number of Participants With Treatment-Emergent Adverse EventsSecondary· Up to 13 months
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, as follows: Grade 1 (mild/asymptomatic; no intervention); Grade 2 (moderate; minimal intervention); Grade 3 (severe/medically significant; hospitalization indicated; disabling); Grade 4 (life-threatening; urgent intervention required); or Grade 5 (fatal). Adverse events (AEs) were reported from clinical laboratory tests, vital sign and weight measurements, physical examinations, and any other medically indicated assessments, including participant inter
Any TEAE
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
3
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
3
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
4
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
5
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
3
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
6
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
4
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
4
Maximum TEAE severity Grade 1
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
0
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
1
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
2
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
1
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
1
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
0
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
1
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
1
Maximum TEAE severity Grade 2
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
1
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
1
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
1
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
1
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
1
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
3
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
3
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
1
Maximum TEAE severity Grade 3
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
1
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
0
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
1
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
3
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
1
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
3
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
0
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
1
Maximum TEAE severity Grade 4
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
0
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
0
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
0
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
0
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
0
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
0
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
0
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
0
Maximum TEAE severity Grade 5
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
1
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
1
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
0
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
0
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
0
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
0
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
0
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
1
TEAE related to SYNB1891
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
3
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
1
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
2
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
3
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
3
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
6
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
2
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
2
TEAE related to atezolizumab
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
0
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
0
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
0
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
0
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
0
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
0
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
0
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
2
Number of Participants With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)Secondary· Up to 13 months
Appropriate imaging of the SYNB1891-injected tumor(s) and up to 5 target (noninjected) lesions was performed at baseline and every 2 cycles during the treatment period. Tumor response was assessed by the local investigator using RECIST 1.1 (Eisenhauer et al 2009). Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stabl
Group
Value
95% CI
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
1
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
1
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
1
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
1
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
1
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
1
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
1
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
2
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
1
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
1
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
3
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
3
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
2
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
2
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
3
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
1
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs occurring from the time a participant signed informed consent through the safety follow-up period were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The longest duration of study participation for any participant was 13 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm 1 Cohort 1: SYNB1891 Monotherapy (1 × 10^6 Live Cells)
Serious: 1/3 (33%)
Deaths: 2/3
Arm 1 Cohort 2: SYNB1891 Monotherapy (3 × 10^6 Live Cells)
Serious: 1/3 (33%)
Deaths: 2/3
Arm 1 Cohort 3: SYNB1891 Monotherapy (1 × 10^7 Live Cells)
Serious: 1/4 (25%)
Deaths: 0/4
Arm 1 Cohort 4: SYNB1891 Monotherapy (3 × 10^7 Live Cells)
Serious: 3/5 (60%)
Deaths: 1/5
Arm 1 Cohort 5: SYNB1891 Monotherapy (1 × 10^8 Live Cells)
Serious: 0/3 (0%)
Deaths: 0/3
Arm 1 Cohort 6: SYNB1891 Monotherapy (3 × 10^8 Live Cells)
Serious: 3/6 (50%)
Deaths: 0/6
Arm 2 Cohort 1: SYNB1891 (1 × 10^7 Live Cells) + Atezolizumab
Serious: 0/4 (0%)
Deaths: 0/4
Arm 2 Cohort 2: SYNB1891 (3 × 10^7 Live Cells) + Atezolizumab
Serious: 2/4 (50%)
Deaths: 1/4
Serious adverse events (14 terms)
Reaction
System
Arm 1 Cohort 1: SYNB1891 M…
Arm 1 Cohort 2: SYNB1891 M…
Arm 1 Cohort 3: SYNB1891 M…
Arm 1 Cohort 4: SYNB1891 M…
Arm 1 Cohort 5: SYNB1891 M…
Arm 1 Cohort 6: SYNB1891 M…
Arm 2 Cohort 1: SYNB1891 (…
Arm 2 Cohort 2: SYNB1891 (…
Cytokine release syndrome
Immune system disorders
—
—
—
—
—
—
—
—
Aspiration
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
—
—
—
—
Syncope
Nervous system disorders
—
—
—
—
—
—
—
—
Synovial sarcoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
—
—
Tracheal haemorrhage
Injury, poisoning and procedural complications
—
—
—
—
—
—
—
—
Transient ischaemic attack
Nervous system disorders
—
—
—
—
—
—
—
—
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
—
—
Vaginal haemorrhage
Reproductive system and breast disorders
—
—
—
—
—
—
—
—
Other adverse events (95 terms — click to expand)
Reaction
System
Arm 1 Cohort 1: SYNB1891 M…
Arm 1 Cohort 2: SYNB1891 M…
Arm 1 Cohort 3: SYNB1891 M…
Arm 1 Cohort 4: SYNB1891 M…
Arm 1 Cohort 5: SYNB1891 M…
Arm 1 Cohort 6: SYNB1891 M…
Arm 2 Cohort 1: SYNB1891 (…
Arm 2 Cohort 2: SYNB1891 (…
Chills
General disorders
—
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05764239 — Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
· Phase 3
· terminated
NCT05462132 — Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
· Phase 1
· completed
NCT05377112 — Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bow
· EARLY_PHASE1
· completed
NCT04984525 — Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers
· Phase 1
· completed
NCT04629170 — Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Synlogic
Last refreshed: 3 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04167137.