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Radioisotope Therapy

RYZ101 Alone and with Pembrolizumab for Breast Cancer (TRACY-1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by RayzeBio, Inc.

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group Performance Status of ≤ 2

At least one RECIST v1.1-measurable tumor lesion that is SSTR-PET positive

Must not have

Significant cardiovascular disease

Prior RPT, including radioembolization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after all subjects in randomization have received at least 3 doses of ryz101 or have discontinued study treatment (assessed up to 1 year)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called 225Ac-DOTATATE (RYZ101) for patients with a specific type of breast cancer. They will be testing this treatment alone and in combination

Who is the study for?

This trial is for individuals with ER+, HER2-negative breast cancer that can't be removed by surgery or has spread to other parts of the body. Participants must have tumors expressing SSTRs, a type of receptor.

What is being tested?

The study is testing RYZ101, a targeted radiation therapy, both alone and combined with pembrolizumab, an immunotherapy drug. It's in early stages (Phase 1b/2) to see how safe it is and how well it works.

What are the potential side effects?

Possible side effects include nausea, fatigue from radiation therapy (RYZ101), and immune-related reactions such as skin rash or inflammation in organs due to pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can perform daily activities with minimal assistance.

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I have a tumor that can be measured and shows up on a specific PET scan.

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My kidneys are working well.

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My breast cancer is advanced, cannot be surgically removed, and cannot be cured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have previously undergone radiation therapy, including radioembolization.

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I have had a severe allergic reaction to similar treatments or imaging agents.

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I have been treated with immune checkpoint inhibitors before.

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My side effects from previous treatments are mild, except for hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after all subjects in randomization have received at least 3 doses of ryz101 or have discontinued study treatment (assessed up to 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after all subjects in randomization have received at least 3 doses of ryz101 or have discontinued study treatment (assessed up to 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after all subjects in randomization have received at least 3 doses of ryz101 or have discontinued study treatment (assessed up to 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation

Expansion

Randomization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ExpansionExperimental Treatment2 Interventions

RYZ101 RP2D Regimen

Group II: Dose EscalationExperimental Treatment1 Intervention

RYZ101 Dose Level -1 RYZ101 Dose Level 1 RYZ101 Dose Level 2 RYZ101 Dose Level 3

Group III: RandomizationActive Control2 Interventions

RYZ101 RP2D RYZ101 RP2D + Pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

RayzeBio, Inc.Lead Sponsor

4 Previous Clinical Trials

379 Total Patients Enrolled

Denis Ferreira, MDStudy DirectorRayzeBio, Inc.

1 Previous Clinical Trials

288 Total Patients Enrolled

~115 spots leftby May 2028

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