Clinical trial · Interventional
A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors
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
NCT07269899CI-TRIAL-00098589Reboot-107recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumor Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
| WTX212A injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Cohort A
- description
- Experimental: Cohort A Intervention: Drug: WTX212A Monotherapy
- interventionNames
- Drug: WTX212A injection
- type
- EXPERIMENTAL
- label
- Experimental: Cohort B
- description
- Experimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy
- interventionNames
- Drug: WTX212A injection
- Radiation: radiotherapy
Primary outcomes (2)
- measure
- Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.