Solid Tumor CancerPhase 1Reboot-107NCT07269899
A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors
A Phase 1 study testing WTX212A injection and radiotherapy in people with Solid Tumor Cancer and Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor Cancer, Cancer
- What is being tested?
- WTX212A injection and radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 25 Nov 2025to 30 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Cancer Center of SUN YAT-senU
Guangzhou, Guangdong, 510000
Ruihua Xu, PhD, 020-87343468, xurh@sysucc.org.cn
Ruihua Xu, PhD
- Recruiting
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: 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.
Read the 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)
- Conditions
- Solid Tumor Cancer, Cancer
- Being tested
- WTX212A injection, radiotherapy
- Keywords
- Solid Tumor Cancer, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WTX212A injectionDrug
Also called Erythrocyte-αPD-1 Antibody Conjugates
Erythrocyte-αPD-1 Antibody Conjugates
radiotherapyRadiation
Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort A | Experimental | Experimental: Cohort A Intervention: Drug: WTX212A Monotherapy Receives: Drug: WTX212A injection |
| Experimental: Cohort B | Experimental | Experimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy Receives: Drug: WTX212A injection; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
Objective Response Rate (ORR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
Measured: 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
Measured: 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
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start25 Nov 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Number of Cohort : 2
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake Therapeutics
- Responsible party
- Principal investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
- Investigators
- RuiHua Xu, PhD, Principal investigator, Cancer Center of SUN YAT-senU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269899
- Sponsor's protocol ID
- Reboot-107
- Acronym
- Reboot-107
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07269899
- Acronym / sponsor ID
- Reboot-107 / Reboot-107
- Conditions
- Solid Tumor Cancer, Cancer
- Keywords
- Solid Tumor Cancer, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Westlake Therapeutics
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Number of Cohort : 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort A | Experimental | Drug: WTX212A injectionExperimental: Cohort A Intervention: Drug: WTX212A Monotherapy |
| Experimental: Cohort B | Experimental | Drug: WTX212A injection, Radiation: radiotherapyExperimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WTX212A injectionAlso: Erythrocyte-αPD-1 Antibody ConjugatesErythrocyte-αPD-1 Antibody Conjugates | Drug | Experimental: Cohort A, Experimental: Cohort B |
| radiotherapyRadiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy | Radiation | Experimental: Cohort B |
Primary outcome
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
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
9 secondary outcomes
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
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
Pharmacokinetic characteristics(Cmax)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic characteristics(Tmax)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic characteristics(AUC0-t)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic characteristics(t1/2)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic characteristics(CL)
Time frame: Through study completion, an average of 1 year
Number of Anti-drug antibody (ADA)
Time frame: Through study completion, an average of 1 year
Percentage of Anti-drug antibody (ADA)
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
RuiHua Xu, PhD principal investigator
Cancer Center of SUN YAT-senU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WTX212A injection and radiotherapy in people with Solid Tumor Cancer and Cancer, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RuiHua Xu, PhD (020-87343468, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy (time frame: From enrollment to the end of treatment，an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.