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.
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;
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;
Single group
THE-0504
DrugTHE-0504 will be administered intravenously according to the treatment regimen specified in the protocol.
Assessment of Maximum Tolerated Dose (MTD)
Assessment of Recommended Phase 2 Dose (RP2D)
Pharmacokinetic assessments of the IMP
Uprising / incidence of anti-THE-05 antibodies (ADA)
Objective Response Rate (ORR) according to RECIST 1.1
Progression-Free Survival (PFS)
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