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Advanced Solid TumorsPhase 1/2NCT05773820

A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors

A Phase 1/2 study testing WJB001 in people with Advanced Solid Tumors, run by Wigen Biomedicine Technology (Shanghai) Co., Ltd. at 11 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase I/II study to evaluate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJB001 capsules in patients with advanced solid tumors, including dose escalation phase, dose expansion phase and cohort expansion phase.The study includes… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
WJB001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
11 sitesChina
Study dates
5 May 2023to 31 Jul 2028
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years or older at the time of informed consent；
  • Patient with advanced malignant solid tumors clearly diagnosed pathologically and/or cytologically, who have failed to receive standard treatment, or who currently no have standard treatment, or who are intolerant to standard treatment;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score ≤1;
  • Life expectancy ≥ 12 weeks;
  • Adequate hematologic and organ function；
  • All acute toxic effects from previous antineoplastic therapy or surgery ；
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  • Fertile women must confirm a negative blood pregnancy test within 7 days prior to the first administration of study drug;and they required to use adequate and effective contraceptive measures throughout the treatment period and within 3 months after the end of treatment;Fertile women in this protocol were defined as sexually mature women: 1) not undergoing hysterectomy or bilateral oophorectomy; 2) 24 months without a continuous period of spontaneous menopause (i.e., having had a period at any time in the previous 24 consecutive months; Amenorrhea after cancer treatment does not exclude fertility). Male participants with a sexual partner who was a woman of reproductive age had to agree to use an effective contraceptive method while using the study drug and for 3 months after the last dose； Specific inclusion criteria：
  • At least one measurable tumor lesion that meets the definition of RECIST v1.1, with no history of biopsy two weeks before screening(applicable to all stages);
  • Subjects with CCNE1 overexpression confirmed by central laboratory (applicable to the dose expansion stage and efficacy expansion stage);
  • For subjects with advanced uterine serous carcinoma, ≤2 lines of therapy for recurrence are allowed after first-line treatment; For subjects with advanced high-grade serous ovarian, fallopian tube, or peritoneal cancer,≤2 lines of therapy after platinum resistance are allowed(applicable to the dose expansion stage and efficacy expansion stage)；

Who cannot join

  • General condition 1) Pregnant or lactating women; 2) Any known allergies to or contraindications to components of the study drug; 3) History of substance abuse; 4) History of alcohol abuse or consumption of more than 28 units of alcohol per week (1 unit =285 ml beer or 25 ml spirits (40%v/v) or 100 ml wine).
  • Previous or current treatment:
  • 1) Previous or current treatment with Wee1 inhibitors; 2) Received cytotoxic chemotherapy drugs,anti-tumor traditional Chinese medicine orother anti-tumor therapies (such as small molecule targeted therapy, etc.)within 4 weeks prior to the first administration of study drug;Or received the investigational drug, macromolecular drug with anti-tumor effect (e.g., monoclonal antibody, antibody-drug conjugate, or bispecific antibody, etc.) within 28 days prior to the first administration of study drug; Or need to continue receiving these medications during the study; 3) The use of a medium or strong inhibitor or inducer of CYP3A or other product (e.g., grapefruit juice) or P-gp inhibitor or inducer was discontinued less than the time before the first dose of WJB001 was administered 5 half-lives of the drug or 14 days, whichever is shorter; 4) Patients with a known organ transplant or stem cell transplant; Major surgery or major trauma (excluding needle biopsy for sample collection) within 4 weeks prior to the first administration of study drug; 5) Radiation therapy was administered within 21 days prior to the first administration of study drug; (except the radiation was delivered to ≤5% of bone marrow volume).3. Past medical history, present medical history and abnormal laboratory indicators:
  • 3. Abnormal laboratory indicators:
  • Having active GI abnormalities including, but not limited to, inability to take oral medication, need for intravenous nutritional support, peptic ulcer, chronic diarrhea (e.g., Crohn's disease, irritable bowel syndrome), or vomiting or other factors that the investigator believes may significantly affect drug absorption, metabolism, or excretion;
  • History of severe ocular disease (except permanent blindness due to disease) that has not recovered to grade 1 or less;
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  • Patients with active brain metastases (except if they had CNS metastases confined to the supratentorial or cerebellar region, had been adequately treated (surgery or radiotherapy), had maintained radiological stability for at least 4 weeks, and did not require corticosteroids for symptom control);
  • Patients with current cancer meningitis or spinal cord compression;
  • Severe or poorly controlled hypertension, including previous history of hypertensive crisis or hypertensive encephalopathy; Adjustment of antihypertensive medication due to poor blood pressure control within 2 weeks before the first dose;Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during the screening period;
  • Patients with clinically significant bleeding symptoms or obvious bleeding tendency within 4 weeks before the first dose, such as gastrointestinal bleeding, gastric ulcer bleeding, obvious gross hematuria, or angiitis;
  • Patients with active HBV and HCV infection: if HBsAg is positive or/and anti-HBc is positive, blood HBV DNA should be tested to confirm that it is above the limit of quantitative detection; If anti-HCV is positive, it is necessary to detect HCV RNA to confirm that the HCV virus copy number exceeds the quantitative detection limit；
  • Known history of human immunodeficiency virus infection or seropositivity for HIV;
  • History of syphilis (both treponema pallidum specific and non-specific antibodies were positive)；
  • History of other primary solid tumor (except a cured solid tumor that has been inactive for ≥5 years before screening and has a very low risk of recurrence）; Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease recurrence; Adequately treated carcinoma in situ with no evidence of disease recurrence, such as carcinoma in situ of the cervix);
  • history of severe or what the investigators considered clinically significant cardiac disease affected the safety assessment；
  • Severe active infectious diseases or other diseases that seriously affect the safety of the first medication occurred during the screening period;
  • There are other factors that the investigator considers may affect the results of the study and interfere with the patient's participation in the study;
  • TP53 showed wild-type phenotype (wild type of TP53 detected by genetic testing or p53 protein expression detected negative by immunohistochemistry);

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

  • Fuxin People's Hospital (Fuxin Women and Children's Medical Center)

    Fuxin, Liaoning, 123000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • Henan Cancer Hospital

    Henan, Zhenzhou, 450000

  • Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530000

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430023

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, 710061

Other trials in China

About this study

Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of WJB001 Capsules in Dose Escalation, Dose Expansion, and Efficacy Expansion in Patients With Advanced Solid Tumors

This is a phase I/II study to evaluate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJB001 capsules in patients with advanced solid tumors, including dose escalation phase, dose expansion phase and cohort expansion phase.The study includes screening, treatment and follow-up periods.

In the Dose Escalation phase:Accelerated titration (the first two dose groups) and "BOIN" combination (the subsequent dose group) were used for dose escalation.

Read more

In the Dose Expansion phase:Based on the previous data, 1 to 2 doses were selected to further evaluate the initial efficacy, safety, tolerability and pharmacokinetic characteristics to confirm RP2D.

In the Efficacy Expansion phase:The preliminary plan of Efficacy expansion phase uses the Simon two-stage optimal method to expand 2 to 3 cohorts.

Being tested
WJB001

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WJB001Drug

    WJB001 Capsules:160mg(or othe dosages),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies,Every 21 days

Study groups in NCT05773820
Study groupRoleWhat they receive
WJB001 capsulesExperimentalDose Escalation: Accelerated titration (the first two dose groups) and "BOIN" combination (the subsequent dose group) were used for dose escalation. Dose Expansion: Based on the previous data, 1 to 2 doses were selected to further evaluate the initial efficacy, safety, tolerability and pharmacokinetic characteristics to confirm RP2D. Cohort Expansion: The preliminary plan of cohort expansion phase uses the Simon two-stage optimal method to expand 2 to 3 cohorts.
Receives: Drug: WJB001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1.Dose limited toxicity (DLT)

    incidence of Dose limited toxicity(DLT);

    Measured: 21d

  2. 2.Adverse event (AE)

    incidence and severity of adverse event (AE), Abnormal changes in laboratory and other tests of clinical significance;

    Measured: 3 years

  3. 3.Serious adverse event (SAE)

    incidence and severity of Serious adverse event (SAE);

    Measured: 3 years

  4. 4.Maximum tolerated dose (MTD)

    Maximum tolerated dose (MTD)

    Measured: 2 years

  5. 5.Recommended phase II dose (RP2D)

    Recommended phase II dose (RP2D)

    Measured: 2 years

  6. 6.Objective response rate(ORR)

    Efficacy endpoints: Objective response rate(ORR) per RECIST v1.1

    Measured: 3 years

Secondary outcomes (19)

  1. 7. Peak time(Tmax)

    Pharmacokinetic (PK) parameter : Peak time(Tmax) after a single dose;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  2. 8.Maximum plasma concentration (Cmax)

    Pharmacokinetic (PK) parameter : Maximum plasma concentration (Cmax) after a single dose;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  3. 9. (AUC 0-t)

    Pharmacokinetic (PK) parameter : Area under blood concentration - time curve(AUC 0-t) after a single dose;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  4. 10. (AUC 0-∞)

    Pharmacokinetic (PK) parameter : Area under blood concentration - time curve(AUC 0-∞) after a single dose;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  5. 11.Apparent volume of distribution (Vd/F)

    Pharmacokinetic (PK) parameter : Apparent volume of distribution (Vd/F) after a single dose;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  6. 12.Clearance rate (CL/F)

    Pharmacokinetic (PK) parameter : Clearance rate (CL/F) after a single dose;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  7. 13. Elimination half-life time ( t1/2)

    Pharmacokinetic (PK) parameter : Elimination half-life time ( t1/2)

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  8. 14.Steady state peak concentration(Cmax,ss)

    Pharmacokinetic (PK) parameter : Steady state peak concentration(Cmax,ss) after repeated administration;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  9. 15.Steady state valley concentration(Cmin,ss)

    Pharmacokinetic (PK) parameter : Steady state valley concentration(Cmin,ss) after repeated administration;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  10. 16.Average steady-state plasma concentration(Cav,ss)

    Pharmacokinetic (PK) parameter : Average steady-state plasma concentration(Cav,ss) after repeated administration;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  11. 17. Steady state peak time(Tmax,ss)

    Pharmacokinetic (PK) parameter : Steady state peak time(Tmax,ss) after repeated administration;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  12. 18.Steady state Area under blood concentration - time curve(AUC0-t,ss)

    Pharmacokinetic (PK) parameter : Steady state Area under blood concentration - time curve(AUC0-t,ss) after repeated administration;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  13. 19.Accumulation Index ( RAC)

    Pharmacokinetic (PK) parameter :Accumulation Index ( RAC) after repeated administration;

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  14. 20.Fluctuation coefficient (FD)

    Pharmacokinetic (PK) parameter : Fluctuation coefficient (FD)

    Measured: Prior to dose on day 1,5,8,12 and at 0.5,1,1.5, 2,3, 4, 6,8,10 and 24 hours post dose on day 1 and day 12 of Cycle 1

  15. 21.Duration of response (DOR)

    Efficacy endpoints: Duration of response (DOR) per RECIST v1.1

    Measured: 3 years

  16. 22.Disease control rate (DCR)

    Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1

    Measured: 3 years

  17. 23.Progression-free survival (PFS)

    Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1

    Measured: 2 years

  18. 24. Overall survival (OS)

    Efficacy endpoints: Overall survival (OS) per RECIST v1.1

    Measured: 3 years

  19. Objective response rate(ORR)

    Efficacy endpoints: Objective response rate(ORR) evaluated by Investigator per RECIST v1.1 in Phase I

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start5 May 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Sequential
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773820
Sponsor's protocol ID
WJB001-001-I
Status last verified
Nov 2026
First submitted
16 Feb 2023
Last updated
3 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing WJB001 in people with Advanced Solid Tumors, run by Wigen Biomedicine Technology (Shanghai) Co., Ltd. at 11 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 10 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

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?

1.Dose limited toxicity (DLT) (time frame: 21d). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05773820.

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 3 Nov 2026.

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