An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors

Last updated: August 2, 2024
Sponsor: Takeda
Overall Status: Terminated

Phase

1

Condition

Neoplasms

Solid Tumors

Treatment

[14C] Subasumstat

Subasumstat

Clinical Study ID

NCT05976334
TAK-981-1004
2023-503449-79
  • Ages > 18
  • All Genders

Study Summary

The main aim of this study is to assess how the human body of adults with advanced or metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following a single 1 hour infusion of subasumstat.

The study consists of two parts. In Part A, participants will receive a single infusion of C14 radiolabeled subasumstat. In Part B, participants will receive subasumstat treatment for up to 1 year.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Participants have histologically or cytologically confirmed advanced (locallyregionally recurrent not amenable to curative therapy) or metastatic solid tumorswith no standard therapeutic option with a proven clinical benefit, are intolerantor have refused them.

  2. Participants have a performance status of 0 or 1 on the Eastern Cooperative OncologyGroup Performance Scale.

  3. Participants demonstrate adequate organ function.

  4. Participants have recovered to Grade 1 or baseline from all toxicity associated withprevious therapy or have the toxicity established as sequela.

Exclusion

Key Exclusion Criteria:

  1. Participants received treatment with radioisotopes within 5 half-lives before thefirst dose of the study drug.

  2. Participants received radiolabelled substances, were exposed to radiation sourceswithin 12 months of the first dose in this study, or is likely to receive radiationexposure or radioisotopes within 12 months of the first dose in this study such thatparticipation in this study would increase their total exposure beyond therecommended safe levels.

  3. Participants received extended field radiotherapy ≤4 weeks before the start oftreatment.

  4. Participants have uncontrolled brain metastasis. Participants with treated brainmetastases are allowed provided they are radiologically stable, without evidence ofprogression for at least 4 weeks by repeat imaging, clinically stable, and withoutrequirement of steroid treatment for at least 14 days before first dose of studytreatment.

  5. Participants had a second malignancy within the previous 3 years, except treatedbasal cell or localized squamous skin carcinomas, prostate cancer, cervicalcarcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, orother malignancy for which the patient is not on active anticancer therapies.

  6. Major surgery ≤14 days from the first dose of study drug and not recovered fullyfrom any complications from surgery.

  7. Baseline prolongation of the QT interval when corrected using Fridericia's formula (QTcF).

  8. Receiving or requires the continued use of medications that are known to be strongor moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4/5 and strongP-glycoprotein (Pgp) inhibitors.

  9. Has active noninfectious pneumonitis or interstitial lung disease that requiredsteroids.

  10. History of allogeneic tissue or solid organ transplant.

  11. Participants have active bacterial infection requiring systemic therapy <14 daysbefore the start of treatment.

  12. Participants have an active HIV or any other relevant congenital or acquiredimmunodeficiency.

  13. Active hepatitis B, or hepatitis C infection.

  14. Any of the following uncontrolled heart diseases: congestive heart failure New YorkHeart Association Grade III or IV, unstable angina, myocardial infarction, unstablesymptomatic ischemic heart disease, uncontrolled hypertension despite appropriatemedical therapy, ongoing symptomatic cardiac arrhythmias >Grade 2, pulmonaryembolism or symptomatic cerebrovascular events, or any other serious cardiaccondition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrialfibrillation on stable anticoagulant therapy is allowed.

Study Design

Total Participants: 3
Treatment Group(s): 2
Primary Treatment: [14C] Subasumstat
Phase: 1
Study Start date:
November 14, 2023
Estimated Completion Date:
July 16, 2024

Study Description

The drug being tested in this study is called [14C]subasumstat. [14C]Subasumstat is being tested to assess mass balance and absorption, distribution, metabolism, excretion (ADME) of people who have advanced or metastatic solid tumors.

The study will enroll approximately 10 patients. Participants will be enrolled to receive a single dose of [14C]subasumstat:

  • [14C]Subasumstat 90 mg

Participants will be administered with a single dose of [14C]subasumstat 90 mg as a 1-hour intravenous (IV) infusion on Day 1 of Part A. All participants will be monitored for up to 14 days postdose. Participants will then have an option to enter Part B of the study to receive non-radiolabelled subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21-day cycle for 3 cycles up to maximum treatment duration of 1 year.

This multi-center trial will be conducted in Hungary. The overall study duration is 12 months for Part A and 24 months for Part B.

Connect with a study center

  • Central Hospital of Northern Pest - Military Hospital

    Budapest, 1062
    Hungary

    Site Not Available

  • Pharmaceutical Research Associates Magyarorszag

    Budapest, 1077
    Hungary

    Site Not Available

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