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

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: Recruiting
• Conditions: Cancer; Solid Tumor Cancer
• Intervention / Treatment: Drug: WTX212A injection; Radiation: radiotherapy

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: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ruihua Xu, PhD; Phone Number: 020-87343468; Email: xurh@sysucc.org.cn
• Study Contact Backup: Name: Huiyan Luo, PhD; Phone Number: 86-20-87343804; Email: Luohy@sysucc.org.cn

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: Ruihua Xu, PhD; Phone Number: 020-87343468; Email: xurh@sysucc.org.cn
      • Sub-Investigator: Huiyan Luo, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy	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	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

Outcome Measure	Measure Description	Time Frame
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).	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	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)	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)	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)	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)	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)	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)	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)	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

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 1 year
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	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Westlake Therapeutics
• Investigators: Principal Investigator: RuiHua Xu, PhD, Cancer Center of SUN YAT-senU

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Solid Tumor Cancer
• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Radiotherapy
• Other Study ID 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