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

NCT05976334 | Terminated Phase 1 Results

• 2 other identifiers: TAK-981-10042023-503449-79-00
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumors

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (5)

• Cumulative Percentage of Urinary Recovery

  Cumulative percentage of \[14C\]-radioactivity excreted in urine up to the last sampling interval.

  Up to 14 days post-dose

• Cumulative Percentage of Fecal Recovery

  Cumulative percentage of \[14C\]-radioactivity excreted in feces up to the last sampling interval.

  Up to 14 days post-dose

• Cumulative Percentage of Combined Recovery

  Cumulative percentage of \[14C\]-radioactivity excreted in urine, and feces up to the last sampling interval.

  Up to 14 days post-dose

• Percentage Of Recovered Total Radioactivity (TRA) In Urine

  Percentage of recovered TRA in urine for each interval over the entire period of collection were reported.

  Post-dose Day 1: 0-6 hours (hr), 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr, Day 12: 240-264 hr

• Percentage Of Recovered Total Radioactivity (TRA) In Feces

  Percentage of recovered TRA in feces for each interval over the entire period of collection were reported.

  Post-dose Day 1: 0-6 hours hr, 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72 hr, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr

Secondary Outcomes (16)

• Cmax: Maximum Observed Plasma Concentration for Subasumstat and TRA in Plasma and Whole Blood

  Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

• Tmax: Time of First Occurrence of Cmax for Subasumstat and TRA in Plasma and Whole Blood

  Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

• AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Subasumstat and TRA in Plasma and Whole Blood

  Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

• Terminal Disposition Phase Half-life (T1/2z) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data

  Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

• Clearance (CL) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data

  Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr

Study Arms (2)

Part A: [14C] Subasumstat

EXPERIMENTAL

Participants received a single dose of \[14C\] subasumstat 90 milligrams (mg), intravenous (IV) infusion on Day 1 in Part A of the study.

Drug: [14C] Subasumstat

Part B: Subasumstat

EXPERIMENTAL

Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.

Drug: Subasumstat

Interventions

[14C] Subasumstat DRUG

\[14C\] Subasumstat IV infusion.

Also known as: TAK-981

Part A: [14C] Subasumstat

Subasumstat DRUG

Subasumstat IV infusion.

Also known as: TAK-981

Part B: Subasumstat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants have histologically or cytologically confirmed advanced (locally regionally recurrent not amenable to curative therapy) or metastatic solid tumors with no standard therapeutic option with a proven clinical benefit, are intolerant or have refused them.
• Participants have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
• Participants demonstrate adequate organ function.
• Participants have recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela.

You may not qualify if:

• Participants received treatment with radioisotopes within 5 half-lives before the first dose of the study drug.
• Participants received radiolabelled substances, were exposed to radiation sources within 12 months of the first dose in this study, or is likely to receive radiation exposure or radioisotopes within 12 months of the first dose in this study such that participation in this study would increase their total exposure beyond the recommended safe levels.
• Participants received extended field radiotherapy ≤4 weeks before the start of treatment.
• Participants have uncontrolled brain metastasis. Participants with treated brain metastases are allowed provided they are radiologically stable, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days before first dose of study treatment.
• Participants had a second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the patient is not on active anticancer therapies.
• Major surgery ≤14 days from the first dose of study drug and not recovered fully from any complications from surgery.
• Baseline prolongation of the QT interval when corrected using Fridericia's formula (QTcF).
• Receiving or requires the continued use of medications that are known to be strong or moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4/5 and strong P-glycoprotein (Pgp) inhibitors.
• Has active noninfectious pneumonitis or interstitial lung disease that required steroids.
• History of allogeneic tissue or solid organ transplant.
• Participants have active bacterial infection requiring systemic therapy \<14 days before the start of treatment.
• Participants have an active HIV or any other relevant congenital or acquired immunodeficiency.
• Active hepatitis B, or hepatitis C infection.
• Any of the following uncontrolled heart diseases: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias \>Grade 2, pulmonary embolism or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Central Hospital of Northern Pest - Military Hospital

Budapest, 1062, Hungary

Location

Pharmaceutical Research Associates Magyarorszag

Budapest, 1077, Hungary

Location

Related Links

• To obtain more information on the study, click this link.

MeSH Terms

Interventions

TAK-981

Limitations and Caveats

The enrollment for the study was halted by the sponsor for business reasons.

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: November 14, 2023
• Primary Completion: June 21, 2024
• Study Completion: July 16, 2024
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2)