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BBO-11818 in Adult Subjects With KRAS Mutant Cancer

NCT ID: NCT06917079

Last Updated: 2026-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

387 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2029-09-30

Brief Summary

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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.

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Detailed Description

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This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab +/- cis/carboplatin + pemetrexed, cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes dose escalation phase and dose expansion phase.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Phase 1a: sequential/parallel, Phase 1b: parallel
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Pembrolizumab

Intervention Type DRUG

Patients will receive IV pembrolizumab

Platinum chemotherapy (cisplatin or carboplatin)

Intervention Type DRUG

Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

Pemetrexed

Intervention Type DRUG

Patients will receive IV pemetrexed

Cohort 1d - Dose Escalation Combination Therapy (Cetuximab)

Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Cetuximab

Intervention Type DRUG

Patients will receive IV cetuximab

Cohort 1e - Dose Escalation Combination Therapy (FOLFOX + Cetuximab)

Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) and FOLFOX infusion (IV)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Cetuximab

Intervention Type DRUG

Patients will receive IV cetuximab

FOLFOX

Intervention Type DRUG

Patients will receive IV FOLFOX

Cohort 1f - Dose Escalation Combination Therapy (NALIRIFOX)

Participants enrolled in this cohort will receive BBO-11818 in combination with NALIRIFOX infusion (IV)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

NALIRIFOX

Intervention Type DRUG

Patients will receive IV NALIRIFOX

Cohort 1g - 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)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Gemcitabine

Intervention Type DRUG

Patients will receive IV Gemcitabine

Nab-paclitaxel

Intervention Type DRUG

Patients will receive IV Nab-Paclitaxel

Cohort 2a - Dose Expansion Monotherapy

Participants enrolled in this cohort will receive BBO-11818 as monotherapy

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Cohort 2b - Dose Expansion Combination (Pembrolizumab)

Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Pembrolizumab

Intervention Type DRUG

Patients will receive IV pembrolizumab

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)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Pembrolizumab

Intervention Type DRUG

Patients will receive IV pembrolizumab

Platinum chemotherapy (cisplatin or carboplatin)

Intervention Type DRUG

Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

Pemetrexed

Intervention Type DRUG

Patients will receive IV pemetrexed

Cohort 2d - Dose Expansion Combination Therapy (Cetuximab)

Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Cetuximab

Intervention Type DRUG

Patients will receive IV cetuximab

Cohort 2e - Dose Expansion Combination Therapy (FOLFOX + Cetuximab)

Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) and FOLFOX infusion (IV)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Cetuximab

Intervention Type DRUG

Patients will receive IV cetuximab

FOLFOX

Intervention Type DRUG

Patients will receive IV FOLFOX

Cohort 2f - Dose Expansion Combination Therapy (NALIRIFOX)

Participants enrolled in this cohort will receive BBO-11818 in combination with NALIRIFOX infusion (IV)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

NALIRIFOX

Intervention Type DRUG

Patients will receive IV NALIRIFOX

Cohort 2g - 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)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Gemcitabine

Intervention Type DRUG

Patients will receive IV Gemcitabine

Nab-paclitaxel

Intervention Type DRUG

Patients will receive IV Nab-Paclitaxel

Cohort 1a - Dose Escalation Monotherapy

Participants enrolled in this cohort will receive BBO-11818 as monotherapy

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab)

Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)

Group Type EXPERIMENTAL

BBO-11818

Intervention Type DRUG

Participants will receive assigned dose of BBO-11818 orally (PO)

Pembrolizumab

Intervention Type DRUG

Patients will receive IV pembrolizumab

Interventions

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BBO-11818

Participants will receive assigned dose of BBO-11818 orally (PO)

Intervention Type DRUG

Pembrolizumab

Patients will receive IV pembrolizumab

Intervention Type DRUG

Platinum chemotherapy (cisplatin or carboplatin)

Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

Intervention Type DRUG

Pemetrexed

Patients will receive IV pemetrexed

Intervention Type DRUG

Cetuximab

Patients will receive IV cetuximab

Intervention Type DRUG

FOLFOX

Patients will receive IV FOLFOX

Intervention Type DRUG

NALIRIFOX

Patients will receive IV NALIRIFOX

Intervention Type DRUG

Gemcitabine

Patients will receive IV Gemcitabine

Intervention Type DRUG

Nab-paclitaxel

Patients will receive IV Nab-Paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Malignancy within the last 2 years as specified in the protocol
* Untreated brain metastases
* Known hypersensitivity to BBO-11818 or its excipients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California San Diego Moores Cancer Center

San Diego, California, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas, United States

Site Status RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

NEXT Oncology

San Antonio, Texas, United States

Site Status RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

[email protected]
650-405-8440

Facility Contacts

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Role: primary

(858) 822-6100

Role: primary

(888) 663-3488

Role: primary

(617)-724-4000

Role: primary

(646)-929-7870

Role: primary

(877) 426-5637

Role: primary

(972) 566-3000

Role: primary

(877) 632-6789

Role: primary

(210) 580-9500

Role: primary

(801) 587-7000

Other Identifiers

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KONQUER-101

Identifier Type: OTHER

Identifier Source: secondary_id

TBBO11818-101

Identifier Type: -

Identifier Source: org_study_id

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