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

T

TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

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

Treatments

Drug: BBO-8520
Drug: Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06343402
ONKORAS-101 (Other Identifier)
TBBO8520-101

Details and patient eligibility

About

A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer

Full description

This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-8520 as a single agent and in combination with pembrolizumab in patients with KRAS (Kirsten rat sarcoma) G12C mutant non-small cell lung cancer. The study includes dose escalation phase, and expansion phase

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically documented locally advanced 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 malignancy within the last 2 years as specified in the protocol
  • Patients with untreated brain metastases
  • Patients with known hypersensitivity to BBO-8520 or its excipients
  • For Cohorts 2a and 2b:
  • Patients with a known hypersensitivity to pembrolizumab or its excipients
  • Patients with active autoimmune disease of history of autoimmune disease that might recur
  • Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis

Other inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

160 participants in 4 patient groups

Cohort 1a - Dose Escalation/Dose Finding Monotherapy
Experimental group
Description:
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
Treatment:
Drug: BBO-8520
Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
Experimental group
Description:
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)
Treatment:
Drug: Pembrolizumab
Drug: BBO-8520
Cohort 2a - Dose Expansion Monotherapy
Experimental group
Description:
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
Treatment:
Drug: BBO-8520
Cohort 2b - Dose Expansion Combination Therapy
Experimental group
Description:
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
Treatment:
Drug: Pembrolizumab
Drug: BBO-8520

Trial contacts and locations

7

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Central trial contact

TheRas

Data sourced from clinicaltrials.gov

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