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Anti-tumor antibiotic

Single Agent Dose Escalation for Solid Tumors (STARMAP Trial)

Phase 1

Recruiting

Research Sponsored by Boundless Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of cycle 1 until 30 days following last dose (each cycle is 28 days)

Awards & highlights

STARMAP Trial Summary

This trial is testing a new drug called BBI-825, which is a powerful inhibitor of a specific enzyme. It is the first time this drug is being tested in humans. The study is looking

Who is the study for?

This trial is for individuals with solid tumors that have developed resistance to other treatments. Participants must have specific gene amplifications linked to this resistance. The study excludes those who don't meet the necessary health standards or might be at risk due to the treatment.Check my eligibility

What is being tested?

The trial is testing BBI-825, a new oral medication aimed at stopping tumor growth by inhibiting an enzyme called RNR. It's given alone or with other targeted therapies, and researchers are looking for the safest and most effective dose.See study design

What are the potential side effects?

As BBI-825 is in early testing stages, potential side effects aren't fully known but may include typical reactions seen with cancer drugs such as nausea, fatigue, blood count changes, and possible liver function impact.

STARMAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of cycle 1 until 30 days following last dose (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of cycle 1 until 30 days following last dose (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of cycle 1 until 30 days following last dose (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825

Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825

Secondary outcome measures

Anti-tumor activity of BBI-825 as determined by RECISTv1.1

Area under the concentration time curve (AUC) of BBI-825

Maximum observed plasma concentration (Cmax) of BBI-825

+2 more

STARMAP Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Agent Dose EscalationExperimental Treatment1 Intervention

Single agent BBI-825, administered orally, twice daily, in 28-day cycles

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boundless BioLead Sponsor

1 Previous Clinical Trials

150 Total Patients Enrolled

Klaus Wagner, MDStudy DirectorBoundless Bio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria to participate in this research investigation?

"Individuals with solid tumors aged between 18 and 99 are eligible for enrollment in this trial, which aims to include a total of 42 participants."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"The study listed on clinicaltrials.gov is not presently accepting applicants. It was initially posted on the 3rd of January, 2024 and last revised on the 7th of March, 2024. Despite this trial being inactive in terms of patient recruitment, there are currently 482 other studies actively seeking participants."

Answered by AI

What is the safety profile of Single Agent Dose Escalation for individuals?

"Given that this is a Phase 1 trial with minimal safety and efficacy data, Single Agent Dose Escalation's safety rating from Power stands at 1."

Answered by AI

What are the specific goals and objectives of this research study?

"As per Boundless Bio, the primary aim of this investigation is to establish the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) for BBI-825. This will be assessed from the beginning of Cycle 1 until 30 days post final dose administration (each cycle lasting 28 days). Furthermore, secondary outcomes such as determining the Maximum observed plasma concentration (Cmax), Area under the concentration time curve (AUC), and Time to Cmax (Tmax) of BBI-825 are also part of this research endeavor."

Answered by AI

Is the inclusion criteria for this research study limited to individuals older than 20 years of age?

"To be considered for participation, individuals aged between 18 and 99 are eligible for this study. It is important to note that there are numerous studies available specifically catering to the younger population under 18 years old as well as a substantial number of trials tailored towards patients above the age of 65 amounting to 457 in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications

2024. "Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299761.

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