Health Trials

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

ConditionsSolid Tumor, AdultMetastatic Breast CancerAdvanced Breast CancerHER2 Mutation-Related TumorsHER2-positive Metastatic Breast CancerKRAS Mutant Metastatic Colorectal CancerMetastatic Lung CancerMetastatic Colorectal CancerAdvanced Lung CancerHR-positive, HER2-negative Advanced Breast CancerHER2-positive Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

About this trial

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

Eligibility criteria

Qualifiers

Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)

Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)

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

Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)

Disqualifiers

Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors

Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)

Patients with untreated and/or non-stable brain metastases

Trial design

Treatments tested in this trial

  • BBO-10203
  • Trastuzumab
  • Fulvestrant
  • Ribociclib
  • FOLFOX
  • Bevacizumab

Treatment groups

392 Participants
are divided into 5 treatment groups

Locations

40
Australia
Scientia Clinical Research2031, RandwickNew South Wales, Australia
Peter MacCallum Cancer Centre3000, MelbourneVictoria, Australia
Brazil
FUTTURA Oncologia90470, Porto AlegreRio Grande do Sul, Brazil
Hospital São Lucas da PUCRS90610, Porto AlegreRio Grande do Sul, Brazil

Sponsors and collaborators

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

Lead sponsor

Source ClinicalTrials.gov