THE-0504 in Patients With Solid Tumors

NCT07646106 | Recruiting Phase 1

• 2 other identifiers: THE-0504-0012023-503787-17-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer (SCLC); Colorectal Carcinoma (CRC); Gastric Cancer (GC); Triple -Negative Breast Cancer; Pancreas Adenocarcinoma

Keywords

THE-0504; Solid tumors; Cancer; Single-centre; Thena Biotech; Italy; Phase 1; Europe

Outcome Measures

Primary Outcomes (2)

• Assessment of Maximum Tolerated Dose (MTD)

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

• Assessment of Recommended Phase 2 Dose (RP2D)

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

Secondary Outcomes (8)

• Pharmacokinetic assessments of the IMP

  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)

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

  From baseline through Cycle 4 (84 days)

• Objective Response Rate (ORR) according to RECIST 1.1

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

• Progression-Free Survival (PFS)

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

• Overall Survival (OS)

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

Study Arms (1)

Treatment arm

EXPERIMENTAL

Drug: THE-0504

Interventions

THE-0504 DRUG

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

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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), 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;
• 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

You may not qualify 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 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;
• 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;

Sponsors & Collaborators

• Thena Biotech S.r.l.: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Colorectal Neoplasms; Stomach Neoplasms; Triple Negative Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gennaro Daniele

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierpaolo Ceci, PhD

CONTACT

+39 0773822658; pierpaolo.ceci@thenabiotech.com

Gennaro Daniele, PhD

CONTACT

+39 0630157300; gennaro.daniele@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 12, 2026
• Study Start: November 13, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)