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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2027-08-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Solid Tumor Cancer Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Number of Cohort : 2

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No Masking

Study Groups

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Experimental: Cohort A

Experimental: Cohort A Intervention: Drug: WTX212A Monotherapy

Group Type EXPERIMENTAL

WTX212A injection

Intervention Type DRUG

Erythrocyte-αPD-1 Antibody Conjugates

Experimental: Cohort B

Experimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy

Group Type EXPERIMENTAL

WTX212A injection

Intervention Type DRUG

Erythrocyte-αPD-1 Antibody Conjugates

radiotherapy

Intervention Type RADIATION

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

Interventions

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WTX212A injection

Erythrocyte-αPD-1 Antibody Conjugates

Intervention Type DRUG

radiotherapy

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

Intervention Type RADIATION

Other Intervention Names

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Erythrocyte-αPD-1 Antibody Conjugates

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No