Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

Conditions

• Advanced Lung Carcinoma
• KRAS G12C
• Metastatic Lung Cancer
• Metastatic Non-Small Cell Lung Cancer
• NSCLC
• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Key Dates

Start date

May 22, 2024

Status verified

Mar 2026

Primary completion

Apr 30, 2031

Completion

Sep 30, 2031

Study Design

Enrollment

350 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1a - Dose Escalation/Dose Finding Monotherapy
  Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
• Experimental: Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
  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)
• Experimental: Cohort 2a - Dose Expansion Monotherapy
  Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
• Experimental: Cohort 2b - Dose Expansion Combination Therapy
  Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
• Experimental: Cohort 1b Safety Lead-In - Dose Expansion Doublet Combination Therapy
  Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
• Experimental: Cohort 1b - Dose Expansion Doublet Combination Therapy
  Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
• Experimental: Cohort 1b Safety Lead-In - Dose Expansion Triplet Combination Therapy
  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)
• Experimental: Cohort 1b - Dose Expansion Triplet Combination Therapy
  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)

Primary Outcome Measure

Adverse Events [ Time Frame: approximately 3 years ]

Central Contacts

• TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
  650-405-8440
  [email protected]

Locations (22)

Find similar trials in Birmingham, AL

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