Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

PHASE1RECRUITING

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

Study details:

This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with Trastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase and an expansion phase.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)
Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)
Stable brain metastases
Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)
Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy
BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i
BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted
BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required

Exclusion criteria

Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
Patients with untreated and/or non-stable brain metastases

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE1

Study ID

NCT06625775

Intervention or treatment

DRUG: BBO-10203

DRUG: Trastuzumab

DRUG: Fulvestrant

DRUG: Ribociclib

DRUG: FOLFOX

DRUG: Bevacizumab

Conditions

Solid Tumor, Adult
Metastatic Breast Cancer
Advanced Breast Cancer
HER2 Mutation-Related Tumors
HER2-positive Metastatic Breast Cancer
KRAS Mutant Metastatic Colorectal Cancer
Metastatic Lung Cancer
Metastatic Colorectal Cancer
Advanced Lung Cancer
HR-positive, HER2-negative Advanced Breast Cancer
HER2-positive Advanced Breast Cancer

Condition: Solid Tumor, Adult, Metastatic Breast Cancer and more
DRUG: BBO-10203 and other drugs
Randwick, New South Wales, Australia and more
Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Scientia Clinical Research

Select from list below to view details:

Scientia Clinical Research
Randwick, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia

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Who is running the clinical trial?

TIdB(OT

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BBO-10203 Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily as monotherapy. This cohort will enroll patients with HER2-positive advanced breast cancer, HR-positive HER2-negative advanced breast cancer, advanced colorectal cancer, and advanced lung cancer.	Drug: BBO-10203
EXPERIMENTAL: BBO-10203 + Trastuzumab Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with trastuzumab. This cohort will enroll patients with HER2-positive advanced breast cancer.	Drug: BBO-10203, Drug: Trastuzumab
EXPERIMENTAL: BBO-10203 + Fulvestrant Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.	Drug: BBO-10203, Drug: Fulvestrant, Drug: Ribociclib
EXPERIMENTAL: BBO10203 + Fulvestrant + Ribociclib Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant and ribociclib as determined in the dose escalation. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.	Drug: BBO-10203, Drug: Fulvestrant, Drug: Ribociclib
EXPERIMENTAL: BBO10203 + FOLFOX + Bevacizumab Participants enrolled in this cohort will receive BBO-10203 tablets orally in combination with FOLFOX and bevacizumab. This cohort will enroll patients with KRAS-mutant advanced colorectal cancer.	Drug: BBO-10203, Drug: FOLFOX, Drug: Bevacizumab

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent	Not Specified	Up to approximately 5 years
Percentage of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)	Not Specified	Up to approximately 5 years
Recommended BBO-10203 dose in combination with trastuzumab, fulvestrant +/- ribociclib, and FOLFOX + bevacizumab	Not Specified	Up to approximately 5 years

Secondary Outcome

Measure	Description	Time Frame
Clinical benefit rate (CBR) as assessed by RECIST v1.1.	Not Specified	Up to approximately 5 years
Duration of response (DOR) as assessed by RECIST v1.1.	Not Specified	Up to approximately 5 years
Progression-free survival (PFS) as assessed by RECIST v1.1	Not Specified	Up to approximately 5 years
Overall survival (OS)	Not Specified	Up to approximately 5 years
Area under the concentration-time curve (AUC	Not Specified	Predose (within 30 minutes) of C1D1 until up to approximately 5 years
Maximum plasma drug concentration (Cmax)	Not Specified	Predose (within 30 minutes) of C1D1 until up to approximately 5 years
Time for maximum plasma drug concentration (Tmax)	Not Specified	Predose (within 30 minutes) of C1D1 until up to approximately 5 years
Objective response rate (ORR) as assessed by RECIST v1.1 for patients with measurable disease	Not Specified	Up to approximately 5 years

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

Claim this trial

References

Clinical Trials Gov: Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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