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NCT Number: NCT06917079

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

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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Key information

Conditions

Non-small Cell Lung Cancer Advanced Lung Carcinoma Bronchial Neoplasms CRC (Colorectal Cancer) Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms KRAS G12A KRAS G12C KRAS G12D KRAS G12S KRAS G12V Lung Diseases Lung Neoplasms Metastatic Colorectal Cancer (CRC) Metastatic Non-Small Lung Cell Cancer Metastatic Pancreatic Ductal Adenocarcinoma NSCLC Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes PDAC - Pancreatic Ductal Adenocarcinoma Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Solid Tumor, Adult Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

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About this study

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, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Life expectancy >24 weeks
  • Adequate organ function

Exclusion criteria

  • Malignancy within the last 2 years as specified in the protocol
  • Untreated brain metastases

Other inclusion/exclusion criteria are specified in the protocol.

Treatment and study plan

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

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

Primary outcomes

  1. Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

    Time frame: approximately 5 years

  2. Determine recommended dose of BBO-11818 in combination with pembrolizumab ± cis/carboplatin + pemetrexed, cetuximab ± mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 + cetuximab, cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203

    Time frame: approximately 5 years

Secondary outcomes

  1. Objective response rate (ORR) per RECIST v1.1 and CNS RECIST

    Time frame: approximately 5 years

  2. Clinical benefit rate (CBR) per RECIST v1.1

    Time frame: approximately 5 years

  3. Duration of Response (DOR) per RECIST v1.1

    Time frame: approximately 5 years

  4. Progression-Free Survival (PFS) per RECIST v1.1

    Time frame: approximately 5 years

  5. Overall Survival (OS)

    Time frame: approximately 5 years

  6. Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Maximum blood concentration (Cmax)

    Time frame: approximately 5 years

  7. Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Time to achieve maximum concentration (Tmax)

    Time frame: approximately 5 years

  8. Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Area under the concentration-time curve (AUC)

    Time frame: approximately 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

(650) 405-4770

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Apr 8, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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