Solid TumorPhase 1NCT05100251
Clinical Trial of WBC100 on Advanced Solid Tumor
A Phase 1 study testing WBC100 QOD, WBC100 QD and WBC100 BID in people with Solid Tumor, run by Zhejiang University at 1 site in China.
Trial summary
This is a phase I clinical study of WBC100 in patients with advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- WBC100 QOD, WBC100 QD and WBC100 BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2021to 6 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Sign informed consent, able to follow protocol requirements；
- Aged 18 to 75 years, male or female
- （1）Dose escalation stage: Histopathology or cytology proven patients with advanced solid tumor with positive C-myc expression who have developed progressive disease or intolerability after at least one line of standard systemic therapies.（2）Dose expansion stage: Histopathology or cytology proven patients with advanced solid tumor of a selected cancer type with positive C-myc expression who have developed progressive disease or intolerability after at least one line of standard systemic therapies. Positive C-myc refers to more than 1% tumor cells are detected 1+ by immunohistochemistry (IHC) in histologic section.
- ECOG Performance Status score: 0 to 2 points
- Expected survival is > 3 months
- Adequate hematologic and organ functions (without persistent supportive treatment)
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- Absolute Neutrophil Count > 1.5 × 109/L, Platelet count ≥ 75 × 109/L, Hemoglobin > 8.5 g/dL
- INR and PT ≤ 2 × ULN
- ALB > 3.0 g/dL, Bilirubin level ≤ 2 × ULN, AST and ALT ≤ 2 × ULN or < 5 × ULN in the presence of liver metastases
- Calculated creatinine clearance (e.g. Cockcroft-Gault) ≥ 60 ml/min or serum creatinine ≤ 1.5 × ULN
- Left ventricular ejection fraction (LVEF) ≥ 50%. Heart rate (HR) ≥ 60 bpm. QT intervals, male ≤ 450 ms, female ≤ 470 ms
- According to RECIST 1.1, patients have at least one evaluable target lesion(only for dose expansion stage)
- Female patients of child-bearing potential or male subjects whose spouses are women of childbearing potential must agree to use a reliable method of contraception (IUD, oral contraceptive, condom) throughout the treatment period and for 3 months after discontinuation of WBC100. Female patients of child-bearing age must undergo a serum pregnancy test before the initiation of the study and the result must be negative.
Who cannot join
- Allergic to WBC100 or its excipients or with allergic constitution
- Major surgery, active ulcer or unhealing wound occurred within 4 weeks before first dose
- Taken drugs in other clinical trials within 4 weeks or still in the safety follow-up period
- Subjects have Spinal compression, brain metastases and meningeal metastases (subjects who is asymptomatic, stable or with no need for steroid for at least 4 weeks before first dose are allowed)
- Subjects have history of cardiac insufficiency (NYHA III-IV) or uncontrolled congestive heart failure (NYHA II-IV) within 6 months before consent
- Subjects have risk factors of QT intervals prolongation or arrhythmia, such as Idiopathic Q-T interval prolongation syndrome or history of drug induced arrhythmia
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- Subject have any condition within 6 months before consent: unstable angina pectoris requiring surgical intervention, uncontrolled hypertension (systolic pressure ≥ 140 mmHg, diastolic pressure ≥ 90 mmHg), myocardial infarction, stroke (lacunar infarction is allowed), Coronary/peripheral artery bypass surgery, pulmonary embolism
- Infection of HIV, active infection of HBV (HBV DNA > 1000 IU/ml) active infection of HC (HCV-RNA ≥ upper limits of normal)
- History of severe infection within 28 days before enrolled, including uncontrolled infection requiring systemic treatment of bacteria, virus and fungus
- The side effects caused by the previous treatment of the subjects did not return to grade ≤1 according to CTCAE 5.0 with exception of tolerable events determined by investigator such as hair loss and grade 2 Peripheral neuropathy
- Subjects with uncontrolled nausea or vomiting, chronic gastrointestinal diseases, unable to swallow pills, enterostomy, uncontrolled diarrhea or any intestinal surgery that cause insufficient absorption of WBC100
- Subjects taking any strong CYP inducers or inhibitors or Chinese medicine within 7 days prior to the first dose of study drug
- History of malignancy in the last 2 years with the exception of patients with prior history of in situ breast cancer, in situ cervical cancer, basal or squamous cell skin cancer who have already been cured
- Subjects who have antitumor therapy within 28 days prior to first dose of WBC100, such as monoclonal antibody, chemotherapy, radiotherapy and Chinese medicine
- Subjects have mental disorders or history of drug abuse that may limit subjects' participation in this trial
- Unable to tolerate intravenous blood collection
- According to the investigators' evaluation, patients are unable or unwilling to comply with the requirements of the study protocol
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: An Open, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WBC100 in Patients With Advanced Solid Tumor
This is a phase I clinical study of WBC100 in patients with advanced solid tumor.
Read the detailed description
This is a phase I open-label, dose escalation study to evaluate the safety, pharmacokinetics, and preliminary efficacy of WBC100, a drug targeting c-myc, in subjects who have been diagnosed with c-myc positive advanced solid tumor and refractory or intolerant to current standard systemic treatment.
- Conditions
- Solid Tumor
- Being tested
- WBC100 QOD, WBC100 QD, WBC100 BID
- Keywords
- C-myc, Solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBC100 QODDrug
The first stage: single dose escalation according to classic "3+3" dose escalation method. 9 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 0.5 mg QOD. The second dose group is 1mg QOD. The third dose group is 1.5 mg QOD. The fourth dose group is 2.0 mg QOD. The fifth dose group is 2.5 mg QOD. The sixth dose group is 3.0 mg QOD. The seven dose group is 3.5 mg QOD. The 8th dose group is 4.0 mg QOD. The 9th dose group is 4.5 mg QOD. In each dose group, patients take WBC100 once on cycle 0. After a washout period of 2 days, patents start subsequent 4 weeks cycles until progression disease or intolerable toxicity. In each cycle, patient was on WBC100 every for 2 weeks and off for 1 week.
The second stage: One dose levels was chosen according to data from the first stage. 16 c-myc-positive patients with pancreatic cancer was enrolled
WBC100 QDDrug
Single dose escalation according to classic "3+3" dose escalation method. 5 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 1.0 mg QD. The second dose group is 1.5 mg QD. The third dose group is 2.0 mg QD. The fourth dose group is 2.5 mg QD. The fifth dose group is 3.0 mg QD. In each dose group, the patient was on WBC100 until progression disease or intolerable toxicity. Patient was on WBC100 every for for 3 consecutive weeks (with QD dosing for the first 5 days of each week followed by a 2-day rest), followed by a 1-week rest period, with a 4 weeks as one cycle.
WBC100 BIDDrug
Single dose escalation according to classic "3+3" dose escalation method. 4 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 0.5 mg QD. The second dose group is 1mg QD. The third dose group is 1.5 mg QD. The fourth dose group is 2.0 mg QD. The fifth dose group is 2.5 mg QD. The sixth dose group is 3.0 mg QD. In each dose group, the patient was on WBC100 until progression disease or intolerable toxicity. Patient was on WBC100 every for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Once every other day (QOD) | Experimental | (1) Once every other day (QOD): after a single-dose administration (C0) and 2-day washout period, subjects will start receiving multiple doses, for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle Receives: Drug: WBC100 QOD |
| Twice daily (BID) | Experimental | (2) Twice daily (BID): dosing for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle; Receives: Drug: WBC100 BID |
| Once daily (QD) | Experimental | Once daily (QD): dosing 3 consecutive weeks (with QD dosing for the first 5 days of each week followed by a 2-day rest), followed by a 1-week rest period, with a 4 weeks as one cycle Receives: Drug: WBC100 QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Event and Severe Adverse Event
AEs and SAEs will be assessed by CTCAE v5.0
Measured: 2 years
Dose limited toxicity（DLT）
safety
Measured: 28 days
Maximum Tolerated Dose（MTD）
The highest dose level at which < 2 of 6 subjects experienced a dose limiting toxicity during the first 28 days of the treatment period
Measured: 28 days
Secondary outcomes (24)
Cmax
Peak plasma concentration after one dose
Measured: 28 days
Tmax
Time to peak plasma concentration after one dose
Measured: 28 days
AUC0-t
Area under the plasma concentration versus time curve after one dose and multiple dose；time range from 0 to last point when plasma concentration is detectable
Measured: 28 days
AUC0-inf
Area under the plasma concentration versus time curve；time range from 0 to infinity
Measured: 28 days
T1/2
half-life period
Measured: 28 days
λz
elimination rate constant
Measured: 28 days
CL/F
apparent clearance
Measured: 28 days
Vz/F
apparent volume of distribution
Measured: 28 days
Cmax, ss
Steady peak plasma concentration after multiple dose
Measured: 28 days
Cmin, ss
Steady minimal plasma concentration after multiple dose
Measured: 28 days
Cavg
Steady averagel plasma concentration after multiple dose
Measured: 28 days
Tmax, ss
Time to steady peak plasma concentration after multiple dose
Measured: 28 days
CLss/F
steady apparent clearance
Measured: 28 days
Vss/F
steady apparent volume of distribution
Measured: 28 days
ARCmax
Peak concerntration cumulative coefficient
Measured: 28 days
ARAUC
AUC cumulative coefficient
Measured: 28 days
DF
degree of fluctuation
Measured: 28 days
CA19-9
Change of CA19-9
Measured: 28 days
CA125
Change of CA125
Measured: 28 days
Serum ferritin
change of serum ferritin
Measured: 28 days
Progression-free survival (PFS)
The period from the day when the subject receives the first study treatment to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first
Measured: 2 years
Duration of response (DOR)
The period from the first evaluation of complete response ( CR) or partial response (PR) to the first evaluation of progressive disease (PD)or death of any cause
Measured: 2 years
Objective response rate (ORR)
The number of cases in which tumor size is reduced to partial response (PR) or complete response (CR) / the total number of evaluable cases (%). In the event of partial response( PR) or complete response (CR), the subjects should confirm it no less than 4 weeks after the first evaluation
Measured: 2 years
change of tumor size
The major axis change of target lesion relative to baseline
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start17 Dec 2021
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Why it stopped: sponsor's decision to change development strategy (the QOD cohort was completed).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Weben Pharma Co., Ltd
- Responsible party
- Principal investigator, TingBo Liang, First Affiliated Hospital of Zhejiang University
- Investigators
- Tingbo Liang, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100251
- Sponsor's protocol ID
- WB001
- Status last verified
- Feb 2026
- First submitted
- 4 Oct 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WBC100 in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05100251
- Acronym / sponsor ID
- WB001
- Conditions
- Solid Tumor
- Keywords
- C-myc, Solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor's decision to change development strategy (the QOD cohort was completed).
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Weben Pharma Co., Ltd
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 29 Oct 2021 (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 phase I clinical study of WBC100 in patients with advanced solid tumor.
Detailed description
This is a phase I open-label, dose escalation study to evaluate the safety, pharmacokinetics, and preliminary efficacy of WBC100, a drug targeting c-myc, in subjects who have been diagnosed with c-myc positive advanced solid tumor and refractory or intolerant to current standard systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Once every other day (QOD) | Experimental | Drug: WBC100 QOD(1) Once every other day (QOD): after a single-dose administration (C0) and 2-day washout period, subjects will start receiving multiple doses, for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle |
| Twice daily (BID) | Experimental | Drug: WBC100 BID(2) Twice daily (BID): dosing for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle; |
| Once daily (QD) | Experimental | Drug: WBC100 QDOnce daily (QD): dosing 3 consecutive weeks (with QD dosing for the first 5 days of each week followed by a 2-day rest), followed by a 1-week rest period, with a 4 weeks as one cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sign informed consent, able to follow protocol requirements；
- Aged 18 to 75 years, male or female
- （1）Dose escalation stage: Histopathology or cytology proven patients with advanced solid tumor with positive C-myc expression who have developed progressive disease or intolerability after at least one line of standard systemic therapies.（2）Dose expansion stage: Histopathology or cytology proven patients with advanced solid tumor of a selected cancer type with positive C-myc expression who have developed progressive disease or intolerability after at least one line of standard systemic therapies. Positive C-myc refers to more than 1% tumor cells are detected 1+ by immunohistochemistry (IHC) in histologic section.
- ECOG Performance Status score: 0 to 2 points
- Expected survival is > 3 months
Key exclusion criteria (17 listed)
- Allergic to WBC100 or its excipients or with allergic constitution
- Major surgery, active ulcer or unhealing wound occurred within 4 weeks before first dose
- Taken drugs in other clinical trials within 4 weeks or still in the safety follow-up period
- Subjects have Spinal compression, brain metastases and meningeal metastases (subjects who is asymptomatic, stable or with no need for steroid for at least 4 weeks before first dose are allowed)
- Subjects have history of cardiac insufficiency (NYHA III-IV) or uncontrolled congestive heart failure (NYHA II-IV) within 6 months before consent
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 |
|---|---|---|
| WBC100 QODThe first stage: single dose escalation according to classic "3+3" dose escalation method. 9 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 0.5 mg QOD. The second dose group is 1mg QOD. The third dose group is 1.5 mg QOD. The fourth dose group is 2.0 mg QOD. The fifth dose group is 2.5 mg QOD. The sixth dose group is 3.0 mg QOD. The seven dose group is 3.5 mg QOD. The 8th dose group is 4.0 mg QOD. The 9th dose group is 4.5 mg QOD. In each dose group, patients take WBC100 once on cycle 0. After a washout period of 2 days, patents start subsequent 4 weeks cycles until progression disease or intolerable toxicity. In each cycle, patient was on WBC100 every for 2 weeks and off for 1 week. The second stage: One dose levels was chosen according to data from the first stage. 16 c-myc-positive patients with pancreatic cancer was enrolled | Drug | Once every other day (QOD) |
| WBC100 QDSingle dose escalation according to classic "3+3" dose escalation method. 5 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 1.0 mg QD. The second dose group is 1.5 mg QD. The third dose group is 2.0 mg QD. The fourth dose group is 2.5 mg QD. The fifth dose group is 3.0 mg QD. In each dose group, the patient was on WBC100 until progression disease or intolerable toxicity. Patient was on WBC100 every for for 3 consecutive weeks (with QD dosing for the first 5 days of each week followed by a 2-day rest), followed by a 1-week rest period, with a 4 weeks as one cycle. | Drug | Once daily (QD) |
| WBC100 BIDSingle dose escalation according to classic "3+3" dose escalation method. 4 increasing dose levels were set up, with 3 to 6 cases per dose. The first dose group is 0.5 mg QD. The second dose group is 1mg QD. The third dose group is 1.5 mg QD. The fourth dose group is 2.0 mg QD. The fifth dose group is 2.5 mg QD. The sixth dose group is 3.0 mg QD. In each dose group, the patient was on WBC100 until progression disease or intolerable toxicity. Patient was on WBC100 every for 2 consecutive weeks, followed by a 1-week rest period, with 3 weeks as one treatment cycle. | Drug | Twice daily (BID) |
Primary outcome
Frequency of Adverse Event and Severe Adverse Event
Time frame: 2 years
AEs and SAEs will be assessed by CTCAE v5.0
Dose limited toxicity（DLT）
Time frame: 28 days
safety
Maximum Tolerated Dose（MTD）
Time frame: 28 days
The highest dose level at which < 2 of 6 subjects experienced a dose limiting toxicity during the first 28 days of the treatment period
24 secondary outcomes
Cmax
Time frame: 28 days
Tmax
Time frame: 28 days
AUC0-t
Time frame: 28 days
AUC0-inf
Time frame: 28 days
T1/2
Time frame: 28 days
λz
Time frame: 28 days
CL/F
Time frame: 28 days
Vz/F
Time frame: 28 days
Cmax, ss
Time frame: 28 days
Cmin, ss
Time frame: 28 days
Cavg
Time frame: 28 days
Tmax, ss
Time frame: 28 days
CLss/F
Time frame: 28 days
Vss/F
Time frame: 28 days
ARCmax
Time frame: 28 days
ARAUC
Time frame: 28 days
DF
Time frame: 28 days
CA19-9
Time frame: 28 days
CA125
Time frame: 28 days
Serum ferritin
Time frame: 28 days
Progression-free survival (PFS)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
change of tumor size
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: sponsor's decision to change development strategy (the QOD cohort was completed).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tingbo Liang principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WBC100 QOD, WBC100 QD and WBC100 BID in people with Solid Tumor, run by Zhejiang University at 1 site 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 13 inclusion and 17 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: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: sponsor's decision to change development strategy (the QOD cohort was completed).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Event and Severe Adverse Event (time frame: 2 years). The study lists 3 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 17 Feb 2026.