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Small Cell Lung Cancer (SCLC)Phase 1NCT07646106

THE-0504 in Patients With Solid Tumors

A Phase 1 study testing THE-0504 in people with Small Cell Lung Cancer (SCLC) and Colorectal Carcinoma (CRC), run by Thena Biotech S.r.l. at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
THE-0504
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
13 Nov 2024to 1 May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • 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 Breast Cancer (TNBrCa);
  • measurable metastatic disease or locally advanced unresectable tumors;
  • have exhausted all EMA-approved treatment options;
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  • 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 (ability to attend all the planned trial visits according to the time limits included) based on Investigator's judgement;
  • 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 of Note 3 of ICH M3 Guideline, for the entire duration of the trial and for a minimum of 12 months after last administration of the IMP.

Who cannot join

  • 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 between the Investigator and Sponsor;
  • ECOG Performance Status > 2;
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  • 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 curative treatment and viral load was confirmed as undetectable;
  • 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 complete washout of the drugs/products under investigation**); or previous participation in the same trial or planned to receive other investigational products during the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pierpaolo Ceci, PhD contact

+39 0773822658

pierpaolo.ceci@thenabiotech.com

Gennaro Daniele, PhD contact

+39 0630157300

gennaro.daniele@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

    Gennaro Daniele, PhD, +39 0630157300, gennaro.daniele@policlinicogemelli.it

    Recruiting

Other trials in Italy

About this study

Official title: NANOFER-THE-0504: A Trial to Assess the Safety and Tolerability of an Investigational Drug THE-0504 for Patients With Solid Tumors

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.

Read the detailed description

The primary aim of the Phase 1 study is to define the Recommended Phase 2 dose and the Maximum Tolerated Dose of THE-0504, as well as to assess the safety and tolerability of escalating doses of THE-0504 administered intravenously to patients with different types of solid tumors. The study will also provide first data in humans concerning safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of THE-0504. For the first-in-human study, a model based on a classic 3+3 design following a modified Fibonacci sequence for dose escalation will be implemented. THE-0504 will be administered IV on day 1 and day 8 of a 21-day cycle. At the end of 21 days from the first treatment of the first patient, the treatment of the second patient of the first Cohort will begin (according to the dose-escalation schedule of the specific Cohort). Intra-patient dose escalation will be permitted to minimize the chance of sub-optimal dosing. The results of the Phase 1 study will drive the future clinical development of THE-0504 in Phase 2 and Phase 3 studies.

Being tested
THE-0504
Keywords
THE-0504, Solid tumors, Cancer, Single-centre, Thena Biotech, Italy, Phase 1, Europe
Medical subject headings
Small Cell Lung Carcinoma, Colorectal Neoplasms, Stomach Neoplasms, Triple Negative Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THE-0504Drug

    THE-0504 will be administered intravenously according to the treatment regimen specified in the protocol.

Study groups in NCT07646106
Study groupRoleWhat they receive
Treatment armExperimentalNot described
Receives: Drug: THE-0504

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Maximum Tolerated Dose (MTD)

    Measured: From enrollment to completion of Cycle 1 (each cycle is 21 days)

  2. Assessment of Recommended Phase 2 Dose (RP2D)

    Measured: During dose escalation, at the end of cycle 1 (each cycle is 21 days)

Secondary outcomes (8)

  1. Pharmacokinetic assessments of the IMP

    Measured: Pre-dose and up to 96 hours (30 minutes, 3 hours, 24 hours, 48 hours and 96 hours) post-dose of the first 3 Cycles (63 days)

  2. Uprising / incidence of anti-THE-05 antibodies (ADA)

    Measured: From baseline through Cycle 4 (84 days)

  3. Objective Response Rate (ORR) according to RECIST 1.1

    Measured: From baseline until disease progression, death, withdrawal or initiation of subsequent anticancer therapy (assessed up to 36 months)

  4. Progression-Free Survival (PFS)

    Measured: From enrollment until disease progression or death from any cause (assessed up to 36 months)

  5. Overall Survival (OS)

    Measured: From first IMP administration until death from any cause (assessed up to 36 months)

  6. Rate of patients with Complete Response (CR) or Partial Response (PR) according to RECIST 1.1

    Measured: From baseline until disease progression, death, withdrawal or initiation of subsequent anticancer therapy (assessed up to 36 months)

  7. Assessment of safety profile of the product THE-0504

    Measured: From first IMP administration through 90 days after last IMP administration

  8. ECOG Performance Status changes from baseline

    Measured: From baseline through 90 days after last IMP administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start13 Nov 2024
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07646106
Sponsor's protocol ID
THE-0504-001
Other IDs
2023-503787-17-00, 2023
Status last verified
Jun 2026
First submitted
3 Jun 2026
Last updated
12 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To the present date, only the sharing of the summary of the clinical results after 30 months from the study completion can be guaranteed. Complete data from individual participants cannot be shared in scientific publications until intellectual property of the Investigational Medicinal Product is granted in all countries currently under evaluation.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing THE-0504 in people with Small Cell Lung Cancer (SCLC) and Colorectal Carcinoma (CRC), run by Thena Biotech S.r.l. at 1 site in Italy.

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 18 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pierpaolo Ceci, PhD (+39 0773822658, pierpaolo.ceci@thenabiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Maximum Tolerated Dose (MTD) (time frame: From enrollment to completion of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07646106.

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 12 Jun 2026.

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