Clinical trial NCT06917079: BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
Keywords: BBOT
BridgeBio Oncology Therapeutics
Phase1
Phase 1a/1b
NSCLC
CRC
PDAC
Metastatic Cancer
Advanced Cancer
Pembrolizumab
Cetuximab
Platinum Chemotherapy
Pemetrexed
KONQUER
KONQUER-101
Lead sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase 1a: sequential/parallel, Phase 1b: parallel
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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, or cetuximab in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes dose escalation phase and dose expansion phase.

Eligibility criteria: 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, or KRAS-amplification
* 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

Other inclusion/exclusion criteria are specified in the protocol.

Primary outcomes:
measure: Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
timeFrame: approximately 5 years
measure: Determine recommended dose of BBO-11818 in combination with pembrolizumab +/- cis/carboplatin + pemetrexed or cetuximab
timeFrame: approximately 5 years
Secondary outcomes:
measure: Objective response rate (ORR) per RECIST v1.1 and CNS RECIST
timeFrame: approximately 5 years
measure: Clinical benefit rate (CBR) per RECIST v1.1
timeFrame: approximately 5 years
measure: Duration of Response (DOR) per RECIST v1.1
timeFrame: approximately 5 years
measure: Progression-Free Survival (PFS) per RECIST v1.1
timeFrame: approximately 5 years
measure: Overall Survival (OS)
timeFrame: approximately 5 years
measure: Pharmacokinetics of BBO-11818: Maximum blood concentration (Cmax)
timeFrame: approximately 5 years
measure: Pharmacokinetics of BBO-11818: Time to achieve Cmax (Tmax)
timeFrame: approximately 5 years
measure: Pharmacokinetics of BBO-11818: Area under the concentration-time curve (AUC)
timeFrame: approximately 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Sarah Cannon Research Institute at Mary Crowley
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References: