A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
This is a single-arm, open-label, investigator-initiated clinical study (IIT) designed to evaluate the preliminary efficacy, safety, tolerability, immunogenicity, and pharmacokinetic (PK) characteristics of WTX212A Injection in patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily signed informed consent, understanding of the study, and willingness and ability to complete all study procedures.
Male or female, aged 18 to 75 years (inclusive).
Patients with histologically and/or cytologically confirmed advanced malignant tumors.
Disqualifiers
Suffering from other serious internal diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, liver cirrhosis, active bleeding, etc., those with uncontrollable or severe cardiovascular diseases, such as NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction, etc., within 6 months before the first dose, difficult to control hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg).
Uncontrollable pleural effusion, peritoneal effusion, or pericardial effusion requiring puncture and drainage, or recurrence requiring re-drainage after puncture and drainage.
History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung function impairment.
Previous IO drug treatment with adverse events related to the drug that required permanent discontinuation of IO treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
WTX212A injection
DrugErythrocyte-αPD-1 Antibody Conjugates
radiotherapy
RadiationRadiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Experimental: Cohort AExperimental treatment 1 intervention
Group B: Experimental: Cohort BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
Objective Response Rate (ORR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
Time frame
From enrollment to the end of treatment，an average of 1 year2
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
Disease Control Rate (DCR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
Time frame
From enrollment to the end of treatment，an average of 1 yearSecondary outcomes
1
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
Progression-Free Survival (PFS).etc of WTX212A monotherapy or WTX212A in combination with radiotherapy, as evaluated using the Evaluation Criteria in Solid Tumors (Version 1.1).
Time frame
Every 6 weeks until the end of the last treatment ，an average of 1 year2
Safety of WTX212A monotherapy or WTX212A in combination with radiotherapy
Incidence of adverse events (AEs), treatment-related AEs, and serious adverse events (SAEs) of WTX212A monotherapy or WTX212A in combination with radiotherapy.
Time frame
From the first treatment to the end of the safety visit，an average of 1 year3
Pharmacokinetic characteristics(Cmax)
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Cmax
Time frame
Through study completion, an average of 1 year4
Pharmacokinetic characteristics(Tmax)
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Tmax
Time frame
Through study completion, an average of 1 yearOther outcomes
1
Assess Biomarkers Relevant to the Study（T-Cell)
Assess the percentages of immune cell subsets (T-Cell ) before and after treatment for advanced malignant tumors, changes in immunophenotyping and other meaningful Biomarkers
Time frame
Through study completion, an average of 1 year2
Assess Biomarkers Relevant to the Study（MDSC)
Assess the percentages of MDSC before and after treatment for advanced malignant tumors, changes in immunophenotyping and other meaningful Biomarkers
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
Westlake Therapeutics
Collaborator
Source ClinicalTrials.gov