BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Study ID
NCT06917079
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Lung Carcinoma
  • CRC (Colorectal Cancer)
  • KRAS G12A
  • KRAS G12C
  • KRAS G12D
  • KRAS G12S
  • KRAS G12V
  • Metastatic Colorectal Cancer (CRC)
  • Metastatic Non-Small Lung Cell Cancer
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • NSCLC
  • Non-Small Cell Lung Cancer
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BBO-11818 — DRUG
    Participants will receive assigned dose of BBO-11818 orally (PO)
  • Pembrolizumab — DRUG
    Patients will receive IV pembrolizumab
  • Platinum chemotherapy (cisplatin or carboplatin) — DRUG
    Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
  • Pemetrexed — DRUG
    Patients will receive IV pemetrexed
  • Cetuximab — DRUG
    Patients will receive IV cetuximab
  • mFOLFOX6 — DRUG
    Patients may receive IV mFOLFOX6
  • mFOLFOX6 — DRUG
    Patients will receive IV mFOLFOX6
  • BBO-10203 — DRUG
    Participants will receive BBO-10203 orally (PO)
  • mFOLFIRINOX — DRUG
    Patients will receive IV mFOLFIRINOX
  • Gemcitabine — DRUG
    Patients will receive IV gemcitabine
  • Nab-paclitaxel — DRUG
    Patients will receive IV nab-paclitaxel

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
665 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1a - Dose Escalation Monotherapy
    Participants enrolled in this cohort will receive BBO-11818 as monotherapy
  • Experimental: Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab)
    Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
  • Experimental: Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)
    Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)
  • Experimental: Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6)
    Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV)
  • Experimental: Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6)
    Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV)
  • Experimental: Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab)
    Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV)
  • Experimental: Cohort 1g - Dose Escalation Combination Therapy (Cetuximab)
    Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)
  • Experimental: Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX)
    Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV)
  • Experimental: Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel)
    Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV)
  • Experimental: Cohort 1j - Dose Escalation Combination Therapy (BBO-10203)
    Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203
  • Experimental: Cohort 2a - Dose Expansion Monotherapy
    Participants enrolled in this cohort will receive BBO-11818 as monotherapy
  • Experimental: Cohort 2b - Dose Expansion Combination (Pembrolizumab)
    Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
  • Experimental: Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)
    Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)
  • Experimental: Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6)
    Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV)
  • Experimental: Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6)
    Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV)
  • Experimental: Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab)
    Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV)
  • Experimental: Cohort 2g - Dose Expansion Combination Therapy (Cetuximab)
    Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)
  • Experimental: Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX)
    Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV)
  • Experimental: Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel)
    Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV)
  • Experimental: Cohort 2j - Dose Expansion Combination Therapy (BBO-10203)
    Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203

Primary Outcome Measure

Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: approximately 5 years ]

Central Contacts

  • TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
    (650) 405-4770
    [email protected]

Locations (16)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research Institute - West Los Angeles OfficeLos AngelesCalifornia90025
310-582-7900
University of California DavisSacramentoCalifornia95817
916-734-5959
University of California San Diego Moores Cancer CenterSan DiegoCalifornia92037
858-822-6100
University of California San Francisco Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
415-885-7796
Yale UniversityNew HavenConnecticut06510
203-200-2486
Moffitt Cancer CenterTampaFlorida33612
888-663-3488
OSF Healthcare Cancer InstitutePeoriaIllinois61637
309-308-3800
Massachusetts General HospitalBostonMassachusetts02114
617-724-4000
Columbia University Irving Medical CenterNew YorkNew York10032
877-426-5637
NYU Langone HealthNew YorkNew York10016
646-929-7870
Vanderbilt University Medical CenterNashvilleTennessee37232
615-936-8422
Sarah Cannon Research Institute at Mary CrowleyDallasTexas75230
972-566-3000
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
877-632-6789
NEXT OncologySan AntonioTexas78229
210-580-9500
Huntsman Cancer InstituteSalt Lake CityUtah84112
801-587-7000
Fred Hutchinson Cancer CenterSeattleWashington98109
206-667-5000

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