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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • BBO-10203

    Drug

    Participants will receive assigned dose of BBO-10203 orally once daily

  • Trastuzumab

    Drug

    Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days

  • Fulvestrant

    Drug

    Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)

  • Ribociclib

    Drug

    Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)

  • FOLFOX

    Drug

    Patients will receive FOLFOX as infusion every 14 days

  • Bevacizumab

    Drug

    Patients will receive bevacizumab as infusion every 28 days

Treatment groups

392 Participants
are divided into 5 treatment groups
Group A: BBO-10203Experimental treatment 1 intervention
Group B: BBO-10203 + TrastuzumabExperimental treatment 2 interventions
Group C: BBO-10203 + FulvestrantExperimental treatment 3 interventions
Group D: BBO10203 + Fulvestrant + RibociclibExperimental treatment 3 interventions
Group E: BBO10203 + FOLFOX + BevacizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent

Time frame
Up to approximately 5 years
2

Percentage of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

Time frame
Up to approximately 5 years
3

Recommended BBO-10203 dose in combination with trastuzumab, fulvestrant +/- ribociclib, and FOLFOX + bevacizumab

Time frame
Up to approximately 5 years

Secondary outcomes

1

Clinical benefit rate (CBR) as assessed by RECIST v1.1.

Time frame
Up to approximately 5 years
2

Duration of response (DOR) as assessed by RECIST v1.1.

Time frame
Up to approximately 5 years
3

Progression-free survival (PFS) as assessed by RECIST v1.1

Time frame
Up to approximately 5 years
4

Overall survival (OS)

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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