Solid TumorsPhase 1NCT05976334
An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors
A Phase 1 study testing [14C] Subasumstat and Subasumstat in people with Solid Tumors, run by Takeda at 2 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- [14C] Subasumstat and Subasumstat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesHungary
- Study dates
- 14 Nov 2023to 16 Jul 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Central Hospital of Northern Pest - Military Hospital
Budapest, 1062
Pharmaceutical Research Associates Magyarorszag
Budapest, 1077
About this study
Official title: A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]Subasumstat in Patients With Advanced or Metastatic Solid Tumors
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.
Read the detailed 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.
- Conditions
- Solid Tumors
- Being tested
- [14C] Subasumstat, Subasumstat
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] SubasumstatDrug
Also called TAK-981
[14C] Subasumstat IV infusion.
SubasumstatDrug
Also called TAK-981
Subasumstat IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Subasumstat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Percentage of Urinary Recovery
Cumulative percentage of [14C]-radioactivity excreted in urine up to the last sampling interval.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Volume of Distribution at Steady-state (Vss) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data
Measured: 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
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data
Measured: 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
Cumulative Amount of Unchanged Subasumstat Excreted Into the Urine (Aeurine)
Cumulative amount of unchanged subasumstat was determined as percentage (%) of dose of subasumstat.
Measured: Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14
Renal Clearance (CLR) for Subasumstat in Urine
Measured: Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
Measured: Up to approximately 8 months
Number of Participants With One or More Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Measured: Up to approximately 8 months
Number of Participants With Abnormal Electrocardiogram Findings
Abnormal laboratory values are those outside of normal range as assessed by the investigator.
Measured: Up to approximately 8 months
Number of Participants With Abnormal Laboratory Values
Laboratory findings will include serum chemistry, hematology and urinalysis. Abnormal laboratory values are those outside of normal range as assessed by the investigator.
Measured: Up to approximately 8 months
Relative Percentage of Circulatory Metabolites in Plasma
Measured: 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 and Day 8: 168 hr
Relative Percentage Excretory Metabolites in Urine
Measured: 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 and Day 8: 168 hr
Relative Percentage of Excretory Metabolites in Feces
M1, M9 and M10 reported as categories were the names for the metabolites.
Measured: 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 and Day 8: 168 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start14 Nov 2023
- Primary completion21 Jun 2024
- Study completion16 Jul 2024
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976334
- Sponsor's protocol ID
- TAK-981-1004
- Other IDs
- 2023-503449-79-00, 2023
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2023
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]Subasumstat in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05976334
- Acronym / sponsor ID
- TAK-981-1004
- Conditions
- Solid Tumors
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 3 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Posted 6 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: [14C] Subasumstat | Experimental | Drug: [14C] SubasumstatParticipants received a single dose of [14C] subasumstat 90 milligrams (mg), intravenous (IV) infusion on Day 1 in Part A of the study. |
| Part B: Subasumstat | Experimental | Drug: SubasumstatParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C] SubasumstatAlso: TAK-981[14C] Subasumstat IV infusion. | Drug | Part A: [14C] Subasumstat |
| SubasumstatAlso: TAK-981Subasumstat IV infusion. | Drug | Part B: Subasumstat |
Primary outcome
Cumulative Percentage of Urinary Recovery
Time frame: Up to 14 days post-dose
Cumulative percentage of [14C]-radioactivity excreted in urine up to the last sampling interval.
Cumulative Percentage of Fecal Recovery
Time frame: Up to 14 days post-dose
Cumulative percentage of [14C]-radioactivity excreted in feces up to the last sampling interval.
Cumulative Percentage of Combined Recovery
Time frame: Up to 14 days post-dose
Cumulative percentage of [14C]-radioactivity excreted in urine, and feces up to the last sampling interval.
Percentage Of Recovered Total Radioactivity (TRA) In Urine
Time frame: 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 TRA in urine for each interval over the entire period of collection were reported.
Percentage Of Recovered Total Radioactivity (TRA) In Feces
Time frame: 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
Percentage of recovered TRA in feces for each interval over the entire period of collection were reported.
16 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for Subasumstat and TRA in Plasma and Whole Blood
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Volume of Distribution at Steady-state (Vss) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data
Time frame: 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
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data
Time frame: 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
Cumulative Amount of Unchanged Subasumstat Excreted Into the Urine (Aeurine)
Time frame: Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14
Renal Clearance (CLR) for Subasumstat in Urine
Time frame: Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 8 months
Number of Participants With One or More Serious Adverse Events (SAEs)
Time frame: Up to approximately 8 months
Number of Participants With Abnormal Electrocardiogram Findings
Time frame: Up to approximately 8 months
Number of Participants With Abnormal Laboratory Values
Time frame: Up to approximately 8 months
Relative Percentage of Circulatory Metabolites in Plasma
Time frame: 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 and Day 8: 168 hr
Relative Percentage Excretory Metabolites in Urine
Time frame: 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 and Day 8: 168 hr
Relative Percentage of Excretory Metabolites in Feces
Time frame: 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 and Day 8: 168 hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).
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Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C] Subasumstat and Subasumstat in people with Solid Tumors, run by Takeda at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Percentage of Urinary Recovery (time frame: Up to 14 days post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.