Health Trials

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

ConditionsNon-Small Cell Lung CancerNSCLCPDAC - Pancreatic Ductal AdenocarcinomaCRC (Colorectal Cancer)Metastatic Non-Small Lung Cell CancerMetastatic Colorectal Cancer (CRC)KRAS G12AKRAS G12CKRAS G12DKRAS G12SKRAS G12VMetastatic Pancreatic Ductal AdenocarcinomaAdvanced Lung CarcinomaSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

About this trial

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

Eligibility criteria

Qualifiers

Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation

Measurable disease by RECIST v1.1

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Life expectancy >24 weeks

Disqualifiers

Malignancy within the last 2 years as specified in the protocol

Untreated brain metastases

Trial design

Treatments tested in this trial

  • BBO-11818
  • Pembrolizumab
  • Platinum chemotherapy (cisplatin or carboplatin)
  • Pemetrexed
  • Cetuximab
  • mFOLFOX6
  • mFOLFOX6
  • BBO-10203
  • mFOLFIRINOX
  • Gemcitabine
  • Nab-paclitaxel

Treatment groups

665 Participants
are divided into 20 treatment groups

20

Treatment groups

See each treatment group below.

Sponsors and collaborators

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Lead sponsor

Source ClinicalTrials.gov