Drugs / BBO-8520
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06343402 | May 2024 → Apr 2031 expected | non-small cell lung carcinoma | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-09-08 | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Results BBOT Announces New BBO-8520 Data; Highlights Strategic Focus on 2L+ NSCLC BBO-8520 Combination as Well as BBO-11818 and BBO-10203 Combinations in KRAS-Mutant Cancers bbotx.com ↗
BBO-8520 plus pembrolizumab demonstrated a 75% ORR at 500 mg QD and 53% ORR across dose levels in 2L+ KRAS G12C inhibitor-experienced NSCLC patients |
| 2026-01-07 | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Results BBOT Announces New Clinical Data Advancing Its Portfolio of Three Innovative and Differentiated RAS and PI3Kα Pipeline Programs bbotx.com ↗
BBO-8520 monotherapy in patients with KRAS G12C non-small cell lung cancer (NSCLC) showed a 65% objective response rate (ORR) and a 66% 6-month progression-free survival (PFS), with 83% of patients eligible for 6-month follow-up remaining on treatment for ≥6 months, alongside a potentially differentiated safety profile. |
| 2025-01-09 | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Regulatory BridgeBio Oncology Therapeutics (BBOT) Granted U.S. FDA Fast Track Designation for BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer bbotx.com ↗ |
| 2024-12-09 | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Results BBO-8520 Preclinical Data Published in Cancer Discovery Supports the Potential for the First-in-Class Molecule to Provide Therapeutic Benefit in KRASG12C Mutant Tumors bbotx.com ↗
Data demonstrates BBO-8520 binds directly to both the “ON” and “OFF” states of KRAS G12C , leading to rapid and complete inhibition of KRAS G12C activity |
| 2024-01-03 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio announces fda clearance of ind application for bbo-8520, a first-in-class direct inhibitor of krasg12c (on) bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, has announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for BBO-8520, a first-in-class orally bioavailable and highly potent small molecule direct inhibitor of KRASG12C (ON) state. |
| 2022-10-17 | Eidos Therapeutics, a BridgeBio company | Results bridgebio pharma highlights its ras precision oncology portfolio and shares compelling data from next-generation g12c inhibitor and novel pi3kα:ras breaker mechanism at the fourth ras initiative symposium bridgebio.com ↗
BBO-8520 showed strong activity in KRASG12C in vivo models including deep regressions and differentiated efficacy compared to a first-generation KRASG12C GDP-only inhibitor |
All press releases naming this drug 7 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BBO-8520 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06343402 ↗ |
| Action | Inhibit | “a KRAS G12C (ON and OFF) inhibitor” NCT06343402 ↗ |
| Route | Oral | “Participants will receive assigned dose of BBO-8520 orally (PO), QD” NCT06343402 ↗ |
| Target | KRAS | “a KRAS G12C (ON and OFF) inhibitor” NCT06343402 ↗ |