A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer

Taiho Pharma

Status and phase: Terminated; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: TAS0612

Study type: Interventional

Funder types: Industry

Identifiers

NCT04586270

TAS0612-101

2020-002304-39 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Dose Escalation:

Have histologically confirmed, locally advanced, and unresectable cancer, or metastatic cancer and have progressed on or were intolerant to standard treatments or refused standard of care (SOC).

Dose Expansion:

Have documented histologically or cytologically confirmed adenocarcinoma of the prostate with documented PTEN loss or loss of function mutation, who have metastatic castration-resistant disease and have:

• Disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3)/modified RECIST 1.1 after the most recent regimen.
• Received androgen receptor directed therapy previously with or without chemotherapy consisting of no more than 2 prior taxane-based regimens.
• Been receiving androgen deprivation therapy with serum testosterone <50 ng/dL (<2.0 nM). Note: previously documented PTEN loss or loss of function mutation from archived tissue sample testing or cfDNA sample testing is acceptable if done in a CLIA certified lab or a locally certified lab.

Have an ECOG score of 0 or 1 Dose Escalation (Part 1): Have no measurable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Dose Expansion (Part 2): Have measurable or no measurable disease per PCWG3/modified RECIST 1.1

• No more than 30 patients with no measurable disease will be enrolled in Dose Expansion (Part 2).

Exclusion criteria

• Participating in medical research not compatible with this study
• Have not discontinued or recovered from previous treatments for cancer
• Have a significant cardiac condition
• Have untreated brain metastases
• Have a primary brain tumor
• Have a serious concomitant disorder
• Unable to swallow or digest pills
• Poorly controlled diabetes
• Concomitant medications or substances that are strong inhibitors/inducers of CYP3A.Study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

TAS0612 Escalation

Experimental group

Description:

TAS0612 administered orally

Treatment:

Drug: TAS0612

TAS0612 Expansion

Experimental group

Description:

TAS0612 administered orally

Treatment:

Drug: TAS0612