18 and older, any sex, with NSCLC. 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.
(Part 1) Incidence of Adverse Events and Clinical Laboratory Abnormalities Defined as Dose-limiting Toxicities (DLTs)Primary· 21 days from the first dosing
Any toxicity not attributable to the disease or disease-related processes under investigation that occurs from the first dose of study treatment in dose-escalation cohorts as defined in the protocol.
Group
Value
95% CI
20mg QD
0
80mg QD
0
160mg, QD
0
320mg, QD
0
480mg, QD
0
600mg, QD
0
160mg, BID
0
200mg, BID
1
240mg, BID
1
(Part 1) Objective Response Rate (ORR)Secondary· Every 6 weeks, approximately 1 year
ORR is estimated by the number of patients with a best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of patients who are evaluable for efficacy.
Group
Value
95% CI
20mg QD
0
80mg QD
0
160mg, QD
1
320mg, QD
0
480mg, QD
0
600mg, QD
0
160mg, BID
0
200mg, BID
0
240mg, BID
1
(Part 1) Pharmacokinetics (PK) Parameters - Peak Concentration (Cmax)Secondary· 0, 1, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1) (each cycle is 21 days)
Peak plasma concentration (Cmax) of BBT-176 from Part 1.
Group
Value
95% CI
20mg QD C1D1
7
± 4
20mg QD C2D1
10
± 5
80mg QD C1D1
159
± 67
80mg QD C2D1
260
± 37
160mg QD C1D1
240
± 75
160mg QD C2D1
638
± 231
320mg QD C1D1
594
± 94
320mg QD C2D1
1416
± 370
480mg QD C1D1
1087
± 470
480mg QD C2D1
2145
± 1438
600mg QD C1D1
NA
± NA
600mg QD C2D1
NA
± NA
(Part 1) PK Parameters - Area Under the Concentration-time Curve (AUC)Secondary· 0, 1, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1) (each cycle is 21 days)
Area under the plasma concentration-time curve (AUC) of BBT-176 from Part 1.
Group
Value
95% CI
20mg QD C1D1
91
± 42
20mg QD C2D1
192
± 89
80mg QD C1D1
1314
± 263
80mg QD C2D1
3584
± 158
160mg QD C1D1
2799
± 1030
160mg QD C2D1
9652
± 5978
320mg QD C1D1
8065
± 2703
320mg QD C2D1
21992
± 5494
480mg QD C1D1
13938
± 6315
480mg QD C2D1
38365
± 21815
600mg QD C1D1
NA
± NA
600mg QD C2D1
NA
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This clinical trial is the first-in-human study of BBT-176. The purpose of this trial is to investigate the safety and tolerability of BBT-176 (Part 1) and to evaluate the anti-tumor activity of BBT-176 (Part 2).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
NCT05920135 — First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR
· Phase 1, PHASE2
· active not recruiting
NCT05483907 — To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF
· Phase 2
· completed
NCT04596293 — Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
· Phase 2
· completed
NCT04478825 — Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis
· Phase 1
· terminated
NCT04138849 — Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 in Healthy Japanese Male
· 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 Bridge Biotherapeutics, Inc.
Last refreshed: 6 June 2025
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/NCT04820023.