Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BBO-8520 · 1 trial · 6 indications
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Number of participants with dose limiting toxicities
| Arm | Type | Description |
|---|---|---|
| Cohort 1a - Dose Escalation/Dose Finding Monotherapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy |
| Cohort 1b - Dose Escalation/Dose Finding Combination Therapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV) |
| Cohort 2a - Dose Expansion Monotherapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy |
| Cohort 2b - Dose Expansion Combination Therapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV) |
| Cohort 1b Safety Lead-In - Dose Expansion Doublet Combination Therapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) |
| Cohort 1b - Dose Expansion Doublet Combination Therapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) |
| Cohort 1b Safety Lead-In - Dose Expansion Triplet Combination Therapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV) |
| Cohort 1b - Dose Expansion Triplet Combination Therapy | EXPERIMENTAL | Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV) |
| Name | Type | Description |
|---|---|---|
| BBO-8520 | DRUG | Participants will receive assigned dose of BBO-8520 orally (PO), QD |
| Pembrolizumab | DRUG | Patients will receive IV pembrolizumab |
| BBO-10203 | DRUG | Participants will receive assigned dose of BBO-8520 orally (PO), QD |
Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Exclusion Criteria: * Patients with mali...
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BBO-8520 is an investigational small molecule being developed for the treatment of non-small cell lung cancer (NSCLC), including metastatic non-small cell lung cancer and advanced lung carcinoma. It is currently in Phase 1 clinical development for these indications.
BBO-8520 targets KRAS, specifically the KRAS G12C mutation, which is a gene involved in cell growth and division. By targeting this mutated gene, BBO-8520 is designed to interfere with cancer cell proliferation in non-small cell lung cancer.
BBO-8520 is being developed by BridgeBio Oncology Therapeutics, Inc., a company listed under the ticker symbol BBOT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with KRAS G12C-mutated non-small cell lung cancer.
BBO-8520 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy.
BBO-8520 is being studied in a Phase 1 open-label trial with the identifier NCT06343402. This trial is recruiting adult subjects with KRAS G12C non-small cell lung cancer and aims to enroll approximately 350 participants across the United States, Australia, Canada, Denmark, and Spain.
BBO-8520 is a distinct investigational compound developed by BridgeBio Oncology Therapeutics. It is not known to be the same as any other marketed drug. Its unique mechanism targets the KRAS G12C mutation, which is a specific genetic alteration found in some non-small cell lung cancers.