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

Part of paid clinical trials in Duarte, California.

Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Study ID
NCT06625775
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BBO-10203 — DRUG
    Participants will receive assigned dose of BBO-10203 orally once daily
  • Trastuzumab — DRUG
    Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days
  • Fulvestrant — DRUG
    Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
  • Ribociclib — DRUG
    Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
  • FOLFOX — DRUG
    Patients will receive FOLFOX as infusion every 14 days
  • Bevacizumab — DRUG
    Patients will receive bevacizumab as infusion every 28 days

Study Details

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.

Key Dates

Start date
Oct 29, 2024
Status verified
Jul 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
392 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent [ Time Frame: Up to approximately 5 years ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University of California Los AngelesLos AngelesCalifornia90095-
University of California San Diego Moores Cancer CenterSan DiegoCalifornia92037-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
Moffitt Cancer CenterTampaFlorida33612-
Indiana University Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Dana-Farber Cancer InsituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
St. Lukes Hospital of Kansas CityKansas CityMissouri64111-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University Irving Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
SCRI Oncology PartnersNashvilleTennessee37203-
SCRI at Mary CrowleyDallasTexas75230-
University of Texas Southwestern Medical CenterDallasTexas75390-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Texas San Antonio (UTSA)San AntonioTexas78229-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Wisconsin Institute for Medical ResearchMadisonWisconsin53792-

Find similar trials in Duarte, CA

By condition
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By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of California Los Angeles· Los Angeles, CAUniversity of California San Diego Moores Cancer Center· San Diego, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAMoffitt Cancer Center· Tampa, FLIndiana University Simon Comprehensive Cancer Center· Indianapolis, IN

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