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

NCT07269899 | Recruiting Phase 1

• 1 other identifier: Reboot-107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumor Cancer; Cancer

Keywords

Solid Tumor Cancer; Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy

  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

  From the first treatment to the end of the safety visit，an average of 1 year

• Pharmacokinetic characteristics(Cmax)

  Through study completion, an average of 1 year

• Pharmacokinetic characteristics(Tmax)

  Through study completion, an average of 1 year

• Pharmacokinetic characteristics(AUC0-t)

  Through study completion, an average of 1 year

Other Outcomes (2)

• Assess Biomarkers Relevant to the Study（T-Cell)

  Through study completion, an average of 1 year

• Assess Biomarkers Relevant to the Study（MDSC)

  Through study completion, an average of 1 year

Study Arms (2)

Experimental: Cohort A

EXPERIMENTAL

Experimental: Cohort A Intervention: Drug: WTX212A Monotherapy

Drug: WTX212A injection

Experimental: Cohort B

EXPERIMENTAL

Experimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy

Drug: WTX212A injection; Radiation: radiotherapy

Interventions

WTX212A injection DRUG

Erythrocyte-αPD-1 Antibody Conjugates

Also known as: Erythrocyte-αPD-1 Antibody Conjugates

Experimental: Cohort A; Experimental: Cohort B

radiotherapy RADIATION

Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy

Experimental: Cohort B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Westlake Therapeutics: collaborator

Study Sites (2)

Cancer Center of SUN YAT-senU

Guangzhou, Guangdong, 510000, China

RECRUITING

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• RuiHua Xu, PhD

  Cancer Center of SUN YAT-senU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RuiHua Xu, PhD

CONTACT

020-87343468; xurh@sysucc.org.cn

Huiyan Luo, PhD

CONTACT

86-20-87343804; Luohy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Number of Cohort : 2

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: December 8, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

CN (2)