BridgeMD
New treatment option for Small Cell Lung Cancer (SCLC)
Official title THE-0504 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT07646106
What this study is testing
What is THE-0504?
THE-0504 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer (sclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients will be enrolled in the study if they meet all the following criteria:
- written informed consent obtained;
- both gender adult (≥ 18 years) patients;
- diagnosis of solid tumor. Preferably, but non-limited, tumor types are the following: Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC)...
- measurable metastatic disease or locally advanced unresectable tumors;
You likely can't join if
- Patients will not be enrolled if they meet any of the following criteria:
- pregnant (as determined by a blood pregnancy test at the screening visit) or lactating women;
- male patients who are willing to father children during the trial or in the 12 months after the end of IMP administration;
- additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ...
- have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but...
- ECOG Performance Status \> 2;
See the full eligibility criteria
Who can join
- Patients will be enrolled in the study if they meet all the following criteria:
- written informed consent obtained;
- both gender adult (≥ 18 years) patients;
- diagnosis of solid tumor. Preferably, but non-limited, tumor types are the following: Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC), Pancreas Adenocarcinoma (PaAdCa), Gastric Cancer (GC) and Triple Negative...
- measurable metastatic disease or locally advanced unresectable tumors;
- have exhausted all EMA-approved treatment options;
- ECOG Performance Status graded as 0 or 1;
- patients able to understand the full nature and the purpose of the trial, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire trial...
- adequate liver function as assessed by following laboratory tests to be conducted within 28 days before the first dose of study treatment:
- Total bilirubin ≤ 1.5 × ULN (or ≤ 3 X ULN for patients with documented Gilbert-Meulengracht Syndrome, or for patients with hyperbilirubinemia considered due to liver metastasis).
- Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor);
- adequate kidney function as assessed by following laboratory test to be conducted within 28 days before the first dose of study treatment:
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m2 according to the CKD-EPI formula.
- adequate bone marrow function as defined as:
- Hgb ≥ 9 g/dL
- ANC ≥1.5x109/L
- PLT≥100.0 x109/L
- Female patients of childbearing potential and male patients who are sexually active with women of childbearing potential will have to mandatorily use an appropriate method of contraception, according to the definition...
What rules you out
- Patients will not be enrolled if they meet any of the following criteria:
- pregnant (as determined by a blood pregnancy test at the screening visit) or lactating women;
- male patients who are willing to father children during the trial or in the 12 months after the end of IMP administration;
- additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;
- have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enrol after agreement...
- ECOG Performance Status \> 2;
- had not tolerated previously administered Top1 inhibitor treatments;
- known active CNS metastatic disease (patients with CNS metastases that are treated with radiotherapy and are stable for at least 28 days before study treatment start could be considered eligible);
- serious concurrent illness;
- Hgb \< 9 g/dL;
- Transfusion dependent anemia with transfusion dependency of ≥3 months;
- Clinically significant iron metabolism disorders (e.g., sickle cell anemia) or use of iron chelators treatments;
- Iron overload, hereditary hemochromatosis and similar;
- Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment;
- Prolonged QTc interval;
- Multiple Sclerosis (MS) or other demyelinating disease, Eaton-Lambert syndrome, history of haemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
- Non-healing wound(s), except for ulcerative lesions caused by the underlying neoplasm;
- History of severe allergic or anaphylactic reactions to previous protein-based therapy;
- Currently receiving anticoagulation therapy with warfarin;
- Known history of HIV infection, unless all the following are applicable:
- receiving an approved, stable, effective combination antiretroviral therapy regimen for ≥ 3 months prior to the planned first study intervention;
- CD4 T-cell count \> 350 cells/μL
- CD4 T-cell nadir (lowest historical count) \> 350 cells/μL, and viral load confirmed as \< 50 copies/mL.
- HBV infection, unless on stable anti-viral therapy for \> 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable; and HCV infection, unless the participant has received...
- Known autoimmune disease, uncontrolled diabetes, vitiligo, or stable thyroid disease;
- Patients on chronic (more than 10 days) administration of systemic, high-dose corticosteroids (≥4 mg Dexamethasone or equivalent), not amenable for reduction or suspension;
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations;
- History of drugs and/or alcohol abuse;
- Patients considered to be unsuitable to participate, in the Investigator's opinion, for any other reason (e.g. consequences of previous medical and/or surgical procedures or other medical or ethical reasons);
- Planned relocation during the study, which would make impossible to attend the scheduled visits and follow-ups;
- Concomitant participation in other clinical trials or participation in the evaluation of any investigational drugs/products up to 4 weeks before this trial (in any case, enrolment procedure should start only after the...
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Lazio, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Lazio, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.