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Recruiting NCT07269899

A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors

Phase I Interventional Solid Tumor Cancer Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WTX212A injection, radiotherapy.
Who it may be relevant to
Registry conditions: Solid Tumor Cancer, Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Study Evaluating the Preliminary Efficacy and Safety of WTX212A Injection as Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors

Overview

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.

Detailed description

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. The study is divided into two phases: an initial exploratory phase and an expansion phase. The study includes two cohorts: Cohort A (WTX212A monotherapy) and Cohort B (WTX212A in combination with radiotherapy)

Interventions

  • Drug WTX212A injection
    Erythrocyte-αPD-1 Antibody Conjugates
  • Radiation radiotherapy
    Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy

Primary outcome measures

  • Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy [Time frame: From enrollment to the end of treatment，an average of 1 year]
  • Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy [Time frame: From enrollment to the end of treatment，an average of 1 year]
Secondary outcome measures (9)
  • Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy [Time frame: Every 6 weeks until the end of the last treatment ，an average of 1 year]
  • Safety 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 year]
  • Pharmacokinetic characteristics(Cmax) [Time frame: Through study completion, an average of 1 year]
  • Pharmacokinetic characteristics(Tmax) [Time frame: Through study completion, an average of 1 year]
  • Pharmacokinetic characteristics(AUC0-t) [Time frame: Through study completion, an average of 1 year]
  • Pharmacokinetic characteristics(t1/2) [Time frame: Through study completion, an average of 1 year]
  • Pharmacokinetic characteristics(CL) [Time frame: Through study completion, an average of 1 year]
  • Number of Anti-drug antibody (ADA) [Time frame: Through study completion, an average of 1 year]
  • Percentage of Anti-drug antibody (ADA) [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Cancer Center of SUN YAT-senU — Guangzhou
  • Cancer center of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07269899 · Reboot-107

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗