BBO-11818 for KRAS Mutant Cancer

Recruiting at 7 trial locations

Overseen By TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

Disqualifiers: Recent malignancy, Untreated brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

287 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called BBO-11818, an experimental therapy targeting cancers with a specific KRAS mutation, which often makes them difficult to treat. The trial aims to determine if BBO-11818 is safe and effective in shrinking tumors in individuals with advanced, inoperable cancers. Different groups in the trial test BBO-11818 alone or in combination with other cancer drugs like cetuximab or pembrolizumab. It seeks participants with a solid tumor featuring a KRAS mutation, such as in lung, pancreas, or colon cancer, who have not had another cancer in the past two years. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BBO-11818, a new cancer treatment, remains in the early stages of human testing. This means limited information exists about its safety. However, these early studies are crucial for assessing how well people tolerate new treatments. Researchers are testing BBO-11818 alone and in combination with other drugs like cetuximab, pembrolizumab, and chemotherapy drugs (cisplatin/carboplatin and pemetrexed). Each combination targets different aspects of cancer treatment.

As BBO-11818 undergoes its first human tests, the primary goal is to ensure safety and monitor for side effects. The trial will closely observe any unwanted reactions. Since BBO-11818 is in a Phase 1 trial, a complete safety record is not yet available. This phase focuses on determining initial safety and the appropriate dosage.

Participation in this trial will help researchers understand how people respond to BBO-11818 and provide valuable information for future studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BBO-11818 for treating KRAS mutant cancers because it offers a fresh approach compared to existing therapies like chemotherapy or targeted inhibitors. Most standard treatments attack cancer cells broadly, but BBO-11818 is designed to target specific pathways involved in KRAS mutations, potentially leading to more precise and effective outcomes. Additionally, BBO-11818 is being tested both as a standalone treatment (monotherapy) and in combination with other cancer drugs like cetuximab and pembrolizumab, which may enhance its effectiveness by attacking the cancer from multiple angles. This versatility and targeted mechanism make BBO-11818 a promising candidate in the fight against KRAS mutant cancers.

What evidence suggests that this trial's treatments could be effective for KRAS mutant cancer?

Research has shown that BBO-11818, a drug targeting KRAS mutations, exhibits strong anti-tumor effects in early lab studies, particularly against cancers with KRAS mutations. This treatment is highly precise, being over 1000 times more effective on KRAS than on similar mutations like NRAS and HRAS. In this trial, participants will receive BBO-11818 in different treatment arms. Some will receive it as monotherapy, while others will receive it in combination with other drugs, such as pembrolizumab (a type of immunotherapy) or cetuximab (a cancer treatment), which might enhance its effectiveness. Studies suggest that combining different drugs, like MEK and PI3K inhibitors, could be promising in treating KRAS mutant tumors. These findings are encouraging, but more information from human trials is needed to confirm its efficacy. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults with advanced or metastatic solid tumors that have a KRAS mutation can join this trial. Specific cancers include non-small cell lung cancer, colon, pancreatic, colorectal, and stomach cancers. Participants must not be eligible for surgery to remove their tumors.

Inclusion Criteria

Measurable disease by RECIST v1.1

I am fully active or can carry out light work.

My cancer is advanced, cannot be surgically removed, and has a specific KRAS mutation.

Exclusion Criteria

Known hypersensitivity to BBO-11818 or its excipients

I was diagnosed with cancer within the last 2 years.

I have brain metastases that have not been treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive BBO-11818 alone or in combination with other therapies to determine the optimal dose

8-12 weeks

Dose Expansion

Participants receive BBO-11818 at the determined dose to further evaluate safety and efficacy

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BBO-11818

Trial Overview The study is testing BBO-11818's safety and its ability to shrink tumors in patients with KRAS mutations. It's an early-stage trial where BBO-11818 is given alongside standard treatments like Pembrolizumab (immunotherapy), Platinum chemotherapy (cisplatin or carboplatin), Cetuximab (antibody therapy), and Pemetrexed (chemotherapy).

How Is the Trial Designed?

Group I: Cohort 2d - Dose Expansion Combination Therapy (Cetuximab) Experimental Treatment 2 Interventions

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

Group II: Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) Experimental Treatment 4 Interventions

Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)

Group III: Cohort 2b - Dose Expansion Combination (Pembrolizumab) Experimental Treatment 2 Interventions

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

Group IV: Cohort 2a - Dose Expansion Monotherapy Experimental Treatment 1 Intervention

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

Group V: Cohort 1d - Dose Escalation Combination Therapy (Cetuximab) Experimental Treatment 2 Interventions

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

Group VI: Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) Experimental Treatment 4 Interventions

Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)

Group VII: Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab) Experimental Treatment 2 Interventions

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

Group VIII: Cohort 1a - Dose Escalation Monotherapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

Lead Sponsor

Trials

2

Recruited

400+

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

Lead Sponsor

Published Research Related to This Trial

KRAS is a commonly mutated oncogene in aggressive solid tumors like colorectal, lung, and pancreatic cancer, making it a critical target for cancer treatment.

Recent advancements have led to the approval of specific inhibitors for the KRAS G12C mutation, such as adagrasib and sotorasib, for treating lung cancer, marking a significant step forward in targeted cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Mutated KRAS Genes to Treat Solid Tumours. Krishnan, T., Roberts-Thomson, R., Broadbridge, V., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06917079

BBO-11818 in Adult Subjects With KRAS Mutant Cancer 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 ...

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/4378/760277/Abstract-4378-BBO-11818-an-orally-bioavailable

Abstract 4378: BBO-11818, an orally bioavailable, highly ... BBO-11818, an orally bioavailable, highly potent and non-covalent pan-KRAS inhibitor demonstrates robust anti-tumor activity in KRAS-mutant preclinical models.

3. globenewswire.com globenewswire.com/news-release/2025/10/23/3172449/0/en/BBOT-Presents-Preclinical-Data-Demonstrating-Potential-of-BBO-11818-as-a-Potent-panKRAS-Inhibitor-at-the-2025-AACR-NCI-EORTC-International-Conference-on-Molecular-Targets-and-Cance.html

BBOT Presents Preclinical Data Demonstrating Potential of The selectivity of BBO-11818 for KRAS is demonstrated by its >1000-fold lower potency against NRAS, HRAS, and BRAF-mutant cell lines.

4. investors.bbotx.com investors.bbotx.com/news-releases/news-release-details/preclinical-data-presented-2025-aacr-nci-eortc-international

Preclinical Data Presented at the 2025 AACR-NCI-EORTC ... Data demonstrate BBO-10203 blocks RAS-mediated activation of PI3Kα and strongly inhibits pAKT signaling in tumor cells without affecting ...

5. withpower.com withpower.com/trial/phase-1-carcinoma-non-small-cell-lung-2-2025-ef5b9

BBO-11818 for KRAS Mutant Cancer Research shows that combining different inhibitors, like MEK and PI3K, with RAF inhibitors can be effective in treating KRAS mutant tumors. This suggests that ...

6. moffitt.org moffitt.org/clinical-trials-and-studies/clinical-trial-23599/

Clinical Trial 23599 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 ...

7. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06917079

BBO-11818 in Adult Subjects With KRAS Mutant Cancer 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 ...