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

NCT06625775 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BBO-10203

Participants will receive assigned dose of BBO-10203 orally once daily

DRUG

Trastuzumab

Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days

DRUG

Fulvestrant

Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)

DRUG

Ribociclib

Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)

DRUG

FOLFOX

Patients will receive FOLFOX as infusion every 14 days

DRUG

Bevacizumab

Patients will receive bevacizumab as infusion every 28 days

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06625775 on ClinicalTrials.gov