A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients with Advanced Malignant Tumors

Launched by ZHEJIANG UNIVERSITY · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called WTX212A for patients with advanced solid tumors that cannot be surgically removed or have spread to other parts of the body. The study aims to find out if WTX212A is safe and effective for people who have already tried other treatments without success. It is being conducted at multiple locations and is currently looking for participants aged 18 to 75 who have been diagnosed with these types of tumors. To join, participants must be in reasonably good health and able to commit to following the study's procedures.

Participants can expect to receive WTX212A through injections and will be monitored closely throughout the trial to track any side effects and assess how well the treatment is working. Women who can become pregnant will need to take a pregnancy test before starting the treatment, and all participants will need to agree to use effective birth control during the study and for three months afterward. It's important to know that people with serious medical conditions or certain histories may not be eligible for this trial, as the researchers want to ensure everyone's safety while testing this new treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Must signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures; 2. Aged 18 to 75 years old (including threshold); 3. Histopathology diagnosed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment; 4. ECOG≤1； 5. Expected life ≥ 3 months； 6. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; 7. Women of childbearing age must have a negative pregnancy testing results within ≤ 7 days before the first trial drug administration.
• Exclusion Criteria:
• • - 1. Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases, 2. Pleural and ascitic fluids with clinical symptoms and the need for repeated drainage; 3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia; 4. History of adverse events related to the use of IO drugs that require permanent cessation of IO treatment; 5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
• • 6. Symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment; 7. Hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; 8. Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;