RightFit
RecruitingPhase 1

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BBO-11818 in people for the first time to learn about its safety and whether it fights cancer. The drug blocks KRAS, a protein linked to cancer growth. It is for adults with certain KRAS gene changes whose solid tumors have spread nearby and cannot be removed by surgery, or have spread to other parts of the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have cancer confirmed by a tissue test: non-small cell lung cancer, pancreatic cancer, colon or rectal cancer, or another solid tumor.
  • The cancer has spread nearby and cannot be removed by surgery, or has spread to other parts of the body.
  • The cancer has one of these KRAS gene changes: G12A, G12C, G12D, G12S, or G12V.
  • Have cancer that can be measured using the study’s rules.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Be expected to live more than 24 weeks.
  • Have organs that work well enough for the study.

Who can't join

  • Have had another cancer within the past 2 years, as defined in the study’s rules.
  • Have cancer that has spread to the brain and has not been treated.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 * 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.

Study sites (16)

CA

CT

FL

IL

MA

NY

TN

TX

UT

WA