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BBO-11818 in Adult Subjects With KRAS Mutant Cancer

ConditionsNon-Small Cell Lung CancerNSCLCPDAC - Pancreatic Ductal AdenocarcinomaCRC (Colorectal Cancer)Metastatic Non-Small Lung Cell CancerMetastatic Colorectal Cancer (CRC)KRAS G12AKRAS G12CKRAS G12DKRAS G12SKRAS G12VMetastatic Pancreatic Ductal AdenocarcinomaAdvanced Lung CarcinomaSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Malignancy within the last 2 years as specified in the protocol

Untreated brain metastases

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

  • mFOLFOX6

    Drug

    Patients will 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

Treatment groups

665 Participants
are divided into 20 treatment groups

20

Treatment groups

See each treatment group below.

Group A: Cohort 1a - Dose Escalation MonotherapyExperimental treatment 1 intervention
Group B: Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab)Experimental treatment 2 interventions
Group C: Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)Experimental treatment 4 interventions
Group D: Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6)Experimental treatment 3 interventions
Group E: Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6)Experimental treatment 3 interventions
Group F: Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab)Experimental treatment 3 interventions
Group G: Cohort 1g - Dose Escalation Combination Therapy (Cetuximab)Experimental treatment 2 interventions
Group H: Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX)Experimental treatment 2 interventions
Group I: Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel)Experimental treatment 3 interventions
Group J: Cohort 1j - Dose Escalation Combination Therapy (BBO-10203)Experimental treatment 2 interventions
Group K: Cohort 2a - Dose Expansion MonotherapyExperimental treatment 1 intervention
Group L: Cohort 2b - Dose Expansion Combination (Pembrolizumab)Experimental treatment 2 interventions
Group M: Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)Experimental treatment 4 interventions
Group N: Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6)Experimental treatment 3 interventions
Group O: Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6)Experimental treatment 3 interventions
Group P: Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab)Experimental treatment 3 interventions
Group Q: Cohort 2g - Dose Expansion Combination Therapy (Cetuximab)Experimental treatment 2 interventions
Group R: Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX)Experimental treatment 2 interventions
Group S: Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel)Experimental treatment 3 interventions
Group T: Cohort 2j - Dose Expansion Combination Therapy (BBO-10203)Experimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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