A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors (Reboot-107)

November 25, 2025 updated by: Rui-hua Xu, MD, PhD, Sun Yat-sen University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Cancer center of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Cancer Center of SUN YAT-senU
        • Principal Investigator:
          • Ruihua Xu, PhD
        • Contact:
        • Sub-Investigator:
          • Huiyan Luo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily signed informed consent, understanding of the study, and willingness and ability to complete all study procedures.
  2. Male or female, aged 18 to 75 years (inclusive).
  3. Patients with histologically and/or cytologically confirmed advanced malignant tumors.

Exclusion Criteria:

  1. 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).
  2. Uncontrollable pleural effusion, peritoneal effusion, or pericardial effusion requiring puncture and drainage, or recurrence requiring re-drainage after puncture and drainage.
  3. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung function impairment.
  4. Previous IO drug treatment with adverse events related to the drug that required permanent discontinuation of IO treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Cohort A
Experimental: Cohort A Intervention: Drug: WTX212A Monotherapy
Drug: WTX212A injection
Erythrocyte-αPD-1 Antibody Conjugates
Other Names:
  • Erythrocyte-αPD-1 Antibody Conjugates
Experimental: Experimental: Cohort B
Experimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy
Drug: WTX212A injection
Erythrocyte-αPD-1 Antibody Conjugates
Other Names:
  • Erythrocyte-αPD-1 Antibody Conjugates
Radiation: radiotherapy
Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
Time Frame: From enrollment to the end of treatment，an average of 1 year
Objective Response Rate (ORR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
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
Disease Control Rate (DCR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
From enrollment to the end of treatment，an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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).
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
Incidence of adverse events (AEs), treatment-related AEs, and serious adverse events (SAEs) of WTX212A monotherapy or WTX212A in combination with radiotherapy.
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 parameters of peripheral blood in subjects after administration, including but not limited to Cmax
Through study completion, an average of 1 year
Pharmacokinetic characteristics(Tmax)
Time Frame: Through study completion, an average of 1 year
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Tmax
Through study completion, an average of 1 year
Pharmacokinetic characteristics(AUC0-t)
Time Frame: Through study completion, an average of 1 year
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to AUC0-t
Through study completion, an average of 1 year
Pharmacokinetic characteristics(t1/2)
Time Frame: Through study completion, an average of 1 year
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to t1/2
Through study completion, an average of 1 year
Pharmacokinetic characteristics(CL)
Time Frame: Through study completion, an average of 1 year
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to CL
Through study completion, an average of 1 year
Number of Anti-drug antibody (ADA)
Time Frame: Through study completion, an average of 1 year
Describe the number of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA.
Through study completion, an average of 1 year
Percentage of Anti-drug antibody (ADA)
Time Frame: Through study completion, an average of 1 year
Describe the percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA.
Through study completion, an average of 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess Biomarkers Relevant to the Study（T-Cell)
Time Frame: Through study completion, an average of 1 year
Assess the percentages of immune cell subsets (T-Cell ) before and after treatment for advanced malignant tumors, changes in immunophenotyping and other meaningful Biomarkers
Through study completion, an average of 1 year
Assess Biomarkers Relevant to the Study（MDSC)
Time Frame: Through study completion, an average of 1 year
Assess the percentages of MDSC before and after treatment for advanced malignant tumors, changes in immunophenotyping and other meaningful Biomarkers
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Westlake Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: RuiHua Xu, PhD, Cancer Center of SUN YAT-senU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Reboot-107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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