TT125-802 for Cancer

(TT-CSP-001 Trial)

Recruiting at 9 trial locations

Overseen By Silvio Costanzo, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: TOLREMO therapeutics AG

Must not be taking: Strong CYP3A4 inhibitors, inducers

Disqualifiers: Uncontrolled illness, Brain metastases, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, TT125-802 (experimental treatment), to determine its safety and effectiveness for individuals with advanced solid tumors unresponsive to standard treatments. The focus is on understanding the drug's effects on cancer and its potential benefits. The trial seeks participants whose solid tumors have not responded to current treatments. Those with cancer unresponsive to usual care may find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

Do I need to stop my current medications to join the trial?

The trial does not clearly state if you need to stop your current medications. However, you cannot have taken a strong CYP3A4 inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before starting the trial medication.

Is there any evidence suggesting that TT125-802 is likely to be safe for humans?

Research has shown that TT125-802 was safe in earlier studies. In trials with patients who have advanced solid tumors, the treatment was well-tolerated, with no cases of thrombocytopenia, a condition of low platelet count that can cause bruising or bleeding. This suggests that TT125-802 might be safer than some other cancer treatments that cause this side effect.

TT125-802 has also been tested in patients with certain types of lung cancer and other solid tumors. These studies found that the treatment not only showed signs of fighting the cancer but also maintained a good safety record. Overall, the evidence so far suggests that TT125-802 is generally well-tolerated. However, each person considering joining the trial should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TT125-802 for cancer treatment because it offers a novel approach targeting specific cancer pathways that current treatments might not address. Unlike traditional chemotherapy, which can attack both healthy and cancerous cells, TT125-802 aims to selectively target cancer cells, potentially reducing side effects and increasing effectiveness. Additionally, its unique mechanism of action could make it effective against cancers that have become resistant to existing therapies.

What evidence suggests that TT125-802 might be an effective treatment for cancer?

Research has shown that TT125-802, the investigational treatment in this trial, may help shrink tumors in patients with advanced solid tumors. In previous studies, TT125-802 demonstrated early signs of effectiveness, particularly in individuals with drug-resistant non-small cell lung cancer (NSCLC), where it led to tumor shrinkage in 5 out of 7 patients. The drug is well-tolerated, allowing patients to take it without severe side effects. Additionally, TT125-802 has shown promise against certain mutations, such as KRAS G12C and EGFR, which are common in resistant cancer types. This suggests TT125-802 might effectively treat difficult-to-treat cancers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that haven't responded to standard treatments. Participants must have measurable disease, be in good physical condition (ECOG 0 or 1), and have normal organ function. They should agree to lifestyle restrictions including contraception and fasting as needed.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer can be measured by scans.

My blood clotting tests are within the normal range.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TT125-802 as a single agent to assess safety, tolerability, pharmacokinetics, and efficacy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TT125-802

Trial Overview The study is testing TT125-802's safety and effectiveness as a single agent therapy for various types of advanced solid tumors, including those with specific mutations like EGFR and KRAS, squamous cell carcinoma, thalassemia-related cancers, non-small cell lung cancer, etc.

How Is the Trial Designed?

Group I: TT125-802 single agent Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

TOLREMO therapeutics AG

Lead Sponsor

Trials

1

Recruited

50+

Citations

1. tolremo.com tolremo.com/press-releases/2025/20/8/tolremo-therapeutics-completes-first-in-human-dose-escalation-for-tt125-802-and-presents-solid-tumor-monotherapy-results-at-esmo-2025

TOLREMO therapeutics Completes First In Human Dose ... In the now completed dose escalation part of the study, 34 heavily pre-treated solid tumor patients received TT125-802 across 5 dose escalation ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15105

TT125-802, a highly selective, well-tolerated bromodomain ... The safety, tolerability, PK/PD, and preliminary anti-tumor activity of TT125-802 is currently being investigated in a FIH study (NCT06403436).

3. onclive.com onclive.com/view/tt125-802-demonstrates-potential-in-advanced-nsclc-and-solid-tumors

TT125-802 Demonstrates Potential in Advanced NSCLC ... TT125-802 demonstrates early clinical activity and favorable safety in advanced solid tumors, including KRAS G12C– and EGFR-mutant NSCLC. Most ...

4. cancernetwork.com cancernetwork.com/view/fda-grants-2-fast-track-designations-to-tt125-802-in-egfr-kras-g12c-nsclc

FDA Grants 2 Fast Track Designations to TT125-802 in ... TT125-802 monotherapy yielded multiple responses, shrinking tumors in 5 of 7 patients with drug-resistant NSCLC; patients with KRAS G12C and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06403436

NCT06403436 | A Study Evaluating the Safety, Tolerability ... 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.

6. tolremo.com tolremo.com/press-releases/2025/8/28/tolremo-therapeutics-receives-two-fda-fast-track-designations-for-tt125-802-in-pretreated-advanced-or-metastatic-nsclc-with-either-an-egfr-or-a-kras-g12c-mutation

TOLREMO therapeutics Receives Two FDA Fast Track ... TT125-802 is a small molecule CBP/p300 bromodomain inhibitor that shows clinical activity as single agent in solid tumors, ...