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Androgen Receptor Degrader

TAS3681 for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

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

Must have

Male ≥18 years of age

Measurable disease per RECIST 1.1 and/or bone metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, end of week 4, at the end of every 12 weeks, and end of every 12 weeks through study completion, an average of 6 months

Awards & highlights

Study Summary

This trial is testing a new drug, TAS3681, to see if it is safe and effective. The first part of the trial finds the maximum tolerated dose, and the second part tests to see if the drug works at that dose.

Who is the study for?

This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread. They should be in good physical condition, able to take oral medication, have adequate organ function, and agree to use contraception. Participants must not have heart issues or be taking certain other medications.Check my eligibility

What is being tested?

The study tests TAS3681's safety and the highest dose patients can tolerate without severe side effects (Escalation Phase), followed by further evaluation of its safety and initial effectiveness at this dose (Expansion Phase).See study design

What are the potential side effects?

While specific side effects of TAS3681 are not listed here, common ones may include nausea, fatigue, risk of infection due to low blood cell counts, liver problems, diarrhea or constipation. Patients will be closely monitored for any heart-related side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am a man aged 18 or older.

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My cancer can be measured by scans or I have cancer spread to bones.

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I am fully active or can carry out light work.

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I am on hormone therapy for cancer, and my testosterone is below 50 ng/dL.

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I can take medication by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, end of week 4, at the end of every 12 weeks, and end of every 12 weeks through study completion, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, end of week 4, at the end of every 12 weeks, and end of every 12 weeks through study completion, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of week 4, at the end of every 12 weeks, and end of every 12 weeks through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Escalation Phase: Number of patients with treatment-emergent adverse events and significant ECG abnormalities

Expansion Phase: Overall Response Rate (ORR)

Number of patients with dose-limiting toxicities

Secondary outcome measures

Escalation Phase: Accumulation ratio of TAS3681

Escalation Phase: Area under the concentration-time curve of TAS3681

Escalation Phase: Maximum concentration of TAS3681 in plasma

+12 more

Other outcome measures

Change from baseline in Circulating Tumor Cell (CTC) number in blood

Number of patients with AR-v7 positivity in circulating tumor cells

Severity and impact of pain on daily function using Brief Pain Inventory - Short Form (BPI-SF).

Trial Design

1Treatment groups

Experimental Treatment

Group I: TAS3681Experimental Treatment1 Intervention

All participants will receive TAS3681 in 28-day cycles. The Escalation phase includes participants who have progressed after abiraterone, enzalutamide and chemotherapy. Eleven dose escalation cohorts are planned, one of which includes a preliminary assessment of food effect. The MTD/recommended dose for further development will be used for participants in the Expansion Phase. The Expansion Phase will enroll participants who have progressed after abiraterone or enzalutamide with chemotherapy consisting of no more than 2 prior taxane-based therapies (Group A) or without any chemotherapy (Group B). Participants receive TAS3681 until discontinuation criteria are met.

0 / 5Eligibility criteria met