Advanced Solid TumorPhase 1TT-CSP-001NCT06403436
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors
A Phase 1 study testing TT125-802 in people with Advanced Solid Tumor and Adult Solid Tumor, run by TOLREMO therapeutics AG at 7 sites in 3 countries.
Trial summary
The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Adult Solid Tumor, Adult Disease
- What is being tested?
- TT125-802
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 7 Nov 2023to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Males and nonpregnant and non-breastfeeding females, aged ≥ 18 years of age at the time of signing the informed consent.
- Subjects with advanced solid tumors resistant or refractory to standard treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Measurable disease per RECIST 1.1 criteria.
- Adequate hematological function defined by absolute neutrophil count, ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 9 g/dL, and without growth factor treatment or blood transfusion within 2 weeks before the study intervention start.
- Adequate hepatic function defined by total bilirubin level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) level ≤ 3 × ULN, and an alanine aminotransferase (ALT) level ≤ 3 × ULN.
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- Adequate renal function defined by creatinine clearance > 60 mL/min according to the Cockcroft-Gault equation or creatinine levels <1.5 mg/dl.
- Adequate coagulation laboratory assessments, as follows: Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), or international normalized ratio (INR) < 1.5 or within target range if on prophylactic anticoagulation therapy.
- Life expectancy of > 3 months, in the opinion of the Investigator.
- Willing to adhere to contraception, egg and sperm donation, the fasting requirement, and other criteria as described in lifestyle restrictions
- Capable of giving signed informed consent.
Who cannot join
- Clinically significant (i.e., active) uncontrolled intercurrent illness.
- Presence of brain metastases unless clinically stable.
- History or presence of malignancies unless curatively treated with no evidence of disease ≥ 2 years.
- Subjects with known human immunodeficiency virus and/or active viral hepatitis (B and/or C), and subjects on viral hepatitis B therapy are excluded. However, subjects with hepatitis C treated with curative therapy are not considered actively infected.
- Subject received a live vaccine within 30 days prior to the first dose of the study treatment administration.
- Serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease, and/or other situation that may preclude adequate absorption of oral medications.
- Subjects that have received a strong CYP3A4 inhibitor within 7 days prior to the first dose of TT125-802 or a strong CYP3A4 inducer within 14 days prior to the first dose of TT125-802.
- Hypersensitivity to the active substance or to any of the excipients of TT125-802.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Spain3 sites
NEXT Oncology Barcelona
Barcelona, 08023
Vall d'Hebron Institute of Oncology
Barcelona, 08035
NEXT Oncology Madrid
Madrid, 28223
United States2 sites
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203
Switzerland2 sites
Ente Ospedaliero Cantonale
Bellinzona, 6500
Centre Hospitalier Universitaire Vaudois
Lausanne, 1890
About this study
Official title: A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors
The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors.
Read the detailed description
The purpose of this Phase 1, First-in-Human, Open-label Study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TT125-802 as single agent in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Adult Solid Tumor, Adult Disease, Cancer, NSCLC, EGFR
- Being tested
- TT125-802
- Keywords
- TOLREMO, Drug resistance, TT125-802, Small molecule, Bromodomain inhibitor, NSCLC
- Medical subject headings
- Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT125-802Drug
TT125-802 administered orally
| Study group | Role | What they receive |
|---|---|---|
| TT125-802 single agent | Experimental | Not described Receives: Drug: TT125-802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: Day 1 to approximately 16 weeks
Frequency of dose interruptions and dose reductions
Measured: Day 1 to approximately 16 weeks
Incidence of dose-limiting toxicities (DLTs)
Measured: Day 1 to Day 21
Recommended Dose(s) for Expansion
Measured: Day 1 to Day 21
Secondary outcomes (4)
Plasma concentration of TT125-802 in blood
Measured: Day 1 to approximately 16 weeks
Objective response rate (ORR) assessed by RECIST v1.1
Measured: Day 1 to approximately 16 weeks
Duration of response (DOR) according to RECIST v1.1
Measured: Day 1 to approximately 16 weeks
Progression-free survival (PFS) according to RECIST v1.1
Measured: Day 1 to approximately 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start7 Nov 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- TOLREMO therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403436
- Sponsor's protocol ID
- TT-CSP-001
- Acronym
- TT-CSP-001
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06403436
- Acronym / sponsor ID
- TT-CSP-001 / TT-CSP-001
- Conditions
- Advanced Solid Tumor, Adult Solid Tumor, Adult Disease, Cancer, NSCLC, EGFR
- Keywords
- TOLREMO, Drug resistance, TT125-802, Small molecule, Bromodomain inhibitor, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- TOLREMO therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors.
Detailed description
The purpose of this Phase 1, First-in-Human, Open-label Study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TT125-802 as single agent in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TT125-802 single agent | Experimental | Drug: TT125-802 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and nonpregnant and non-breastfeeding females, aged ≥ 18 years of age at the time of signing the informed consent.
- Subjects with advanced solid tumors resistant or refractory to standard treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Measurable disease per RECIST 1.1 criteria.
- Adequate hematological function defined by absolute neutrophil count, ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 9 g/dL, and without growth factor treatment or blood transfusion within 2 weeks before the study intervention start.
Key exclusion criteria (8 listed)
- Clinically significant (i.e., active) uncontrolled intercurrent illness.
- Presence of brain metastases unless clinically stable.
- History or presence of malignancies unless curatively treated with no evidence of disease ≥ 2 years.
- Subjects with known human immunodeficiency virus and/or active viral hepatitis (B and/or C), and subjects on viral hepatitis B therapy are excluded. However, subjects with hepatitis C treated with curative therapy are not considered actively infected.
- Subject received a live vaccine within 30 days prior to the first dose of the study treatment administration.
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 |
|---|---|---|
| TT125-802TT125-802 administered orally | Drug | TT125-802 single agent |
Primary outcome
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day 1 to approximately 16 weeks
Frequency of dose interruptions and dose reductions
Time frame: Day 1 to approximately 16 weeks
Incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 21
Recommended Dose(s) for Expansion
Time frame: Day 1 to Day 21
4 secondary outcomes
Plasma concentration of TT125-802 in blood
Time frame: Day 1 to approximately 16 weeks
Objective response rate (ORR) assessed by RECIST v1.1
Time frame: Day 1 to approximately 16 weeks
Duration of response (DOR) according to RECIST v1.1
Time frame: Day 1 to approximately 16 weeks
Progression-free survival (PFS) according to RECIST v1.1
Time frame: Day 1 to approximately 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TT125-802 in people with Advanced Solid Tumor and Adult Solid Tumor, run by TOLREMO therapeutics AG at 7 sites in 3 countries.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, United States, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) (time frame: Day 1 to approximately 16 weeks). The study lists 4 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 7 Jul 2026.