A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors
A Dose-escalation, Dose-expansion and Efficacy Extension Phase I/II Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of WJB001 Combination Therapy in Patients With Advanced Solid Tumors
1 other identifier
interventional
86
1 country
10
Brief Summary
This is a phase I/II study to preliminarily explore of the safety, tolerability, pharmacokinetics, and efficacy of WJB001 combination therapy, consisting of three stages: Dose escalation (Phase Ia), dose extension (Phase Ib), and efficacy extension (Phase II). The preliminary plan includes seven combination therapy regimens, namely Arm A: WJB001+taxanes (A1: WJB001+paclitaxel, A2: WJB001+albumin paclitaxel); Arm B: WJB001+platinum (B1: WJB001+carboplatin, B2: WJB001+nedaplatin); Arm C: WJB001+paclitaxel+carboplatin; Arm D: WJB001+PARP inhibitor; Arm E: WJB001+VEGF inhibitor; Arm F:WJB001+JS207/JS001（F1：WJB001+JS207，F2：WJB001+JS001）；Arm G：WJB001+JS207/JS001+paclitaxel+carboplatin（G1: WJB001+JS207 +paclitaxel+carboplatin；G2：WJB001+JS001+paclitaxel+carboplatin）.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2025
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2025
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedStudy Start
First participant enrolled
July 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2029
March 27, 2026
March 1, 2026
4 years
April 23, 2025
March 23, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Dose limited toxicity (DLT)
Incidence of Dose limited toxicity(DLT)
21day
Adverse event (AE)
Incidence and severity of adverse event (AE), Abnormal changes in laboratory and other tests of clinical significance
3 years
Serious adverse event (SAE)
Incidence and severity of Serious adverse event (SAE)
3 years
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD)
2 years
Recommended phase II dose (RP2D)
Recommended phase II dose (RP2D)
2 years
Objective response rate(ORR)
Objective response rate(ORR) evaluated by Investigator per RECIST v1.1 in Phase II
3 years
Secondary Outcomes (22)
Peak time(Tmax)
4 Months
Maximum plasma concentration (Cmax)
4 Months
(AUC 0-t)
4 Months
(AUC 0-∞)
4 Months
Apparent volume of distribution (Vd/F)
4 Months
- +17 more secondary outcomes
Other Outcomes (1)
Biomarkers
3 years
Study Arms (7)
WJB001 capsules with Taxanes
EXPERIMENTALIf needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Phase Ia: Participants with advanced solid tumor will receive WJB001 capsules at escalating dose levels after a maximum of 6 cycles of Paclitaxel/Paclitaxel-albumin. Phase Ib/II: Participants with High-grade serous ovarian cancer（HGSOC）,fallopian tube cancer,peritoneal cancer ,or Uterine Serous Carcinoma(USC) will receive WJB001 capsules at escalating dose levels after a maximum of 6 cycles of Paclitaxel/Paclitaxel-albumin Paclitaxel/Paclitaxel-albumin.
WJB001 capsules with Platinum
EXPERIMENTALIf needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Phase Ia: Participants with advanced solid tumor will receive WJB001 capsules at escalating dose levels after a maximum of 6 cycles of carboplatin/Nedaplatin. Phase Ib/II: Participants with High-grade serous ovarian cancer（HGSOC）,fallopian tube cancer,peritoneal cancer ,or Uterine Serous Carcinoma(USC) will receive WJB001 capsules at escalating dose levels after a maximum of 6 cycles of carboplatin/Nedaplatin.
WJB001 capsules with paclitaxel+carboplatin
EXPERIMENTALIf needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Phase Ia: Participants with advanced solid tumor will receive WJB001 capsules at escalating dose levels after a maximum of 6 cycles of Paclitaxel+carboplatin. Phase Ib/II: Participants with High-grade serous ovarian cancer（HGSOC）,fallopian tube cancer,peritoneal cancer ,or Uterine Serous Carcinoma(USC) will receive WJB001 capsules at escalating dose levels iafter a maximum of 6 cycles of Paclitaxel+carboplatin.
WJB001 capsules with PARPi
EXPERIMENTALIf needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Phase Ia: Participants with advanced solid tumor will receive WJB001 capsules at escalating dose levels in combination with PAPPi. Phase Ib/II: Participants with High-grade serous ovarian cancer,fallopian tube cancer（HGSOC）,peritoneal cancer ,or Uterine Serous Carcinoma(USC) will receive WJB001 capsules at escalating dose levels in combination with PAPPi.
WJB001 capsules with VEGFi
EXPERIMENTALIf needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Phase Ia: Participants with advanced solid tumor will receive WJB001 capsules at escalating dose levels in combination with VEGFi. Phase Ib/II: Participants with High-grade serous ovarian cancer（HGSOC）,fallopian tube cancer,peritoneal cancer ,or Uterine Serous Carcinoma(USC) will receive WJB001 capsules at escalating dose levels in combination with VEGFi.
WJB001 capsules with Anti-PD-1 and VEGF bispecific antibodies/ Anti-PD-1 antibodies
EXPERIMENTALIf needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Phase Ia: Participants with advanced solid tumor will receive WJB001 capsules at escalating dose levels in combination with Anti-PD-1 and VEGF bispecific antibodies/ Anti-PD-1 antibodies . Phase Ib/II: Participants with High-grade serous ovarian cancer（HGSOC）,fallopian tube cancer,peritoneal cancer ,or Uterine Serous Carcinoma(USC) will receive WJB001 capsules at escalating dose levels in combination with Anti-PD-1 and VEGF bispecific antibodies/ Anti-PD-1 antibodies.
WJB001 capsules with paclitaxel and carboplatin, together with Anti-PD-1 and VEGF bispecific antibo
EXPERIMENTALIf needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Phase Ia:Participants with advanced solid tumor will receive WJB001 capsules in combination with paclitaxel and carboplatin, together with Anti-PD-1 and VEGF bispecific antibodies/ Anti-PD-1 antibodies . Phase Ib and II:Participants with High-grade serous ovarian cancer,fallopian tube cancer,peritoneal cancer ,or Uterine Serous Carcinoma will receive WJB001 capsules in combination with paclitaxel and carboplatin, together with Anti-PD-1 and VEGF bispecific antibodies/ Anti-PD-1 antibodies .
Interventions
WJB001 Capsules:120mg(or 160mg,80mg,40mg,or 100mg,60mg),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies (e.g., days 1-4, 8-11, 15-18),Every 21 days; Paclitaxel:80 mg/m2(or 60 mg/m2 ,50 mg/m2), Day 1, day 8, day 15, intravenous infusion, 21 days 1 cycle, up to 6 cycles; Paclitaxel-albumin:260mg/m2(220mg/m2,180mg/m2),On day 1, intravenous infusion, 21 days 1 cycle, up to 6 cycles
WJB001 Capsules:80mg(or160mg, 120mg,40mg,or 100mg,60mg),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies (e.g., days 1-4, 8-11, 15-18),Every 21 days; Carboplatin:AUC 5 mg/ml\*min(or 4mg/ml\*min,3mg/ml\*min), Day 1, day 8, day 15, intravenous infusion, 21 days 1 cycle, up to 6 cycles; Nedaplatin:100mg(80mg/m2 ,60mg/m2), Day 1, intravenous infusion, 21 days 1 cycle, up to 6 cycles;
WJB001 Capsules:40mg(or 160mg, 120 mg,80mg,60mg,or 100mg,60mg),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies (e.g., days 1-4, 8-11, 15-18),Every 21 days; Paclitaxel:60 mg/m2, Day 1, day 8, day 15, intravenous infusion, 21 days 1 cycle, up to 6 cycles; Carboplatin:AUC 2mg/ml\*min, Day 1, day 8, day 15, intravenous infusion, 21 days 1 cycle, up to 6 cycles;
WJB001 Capsules:120mg(or 160mg,80mg,40mg,or 100mg,60mg),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies (e.g., days 1-4, 8-11, 15-18),Every 21 days; Niraparib:Niraparib:300mg(or 200mg,100mg),Oral,QD,Every 21 days;
WJB001 Capsules:120mg(or 160mg,80mg,40mg,or 100mg,60mg),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies (e.g., days 1-4, 8-11, 15-18),Every 21 days; Bevacizumab:15mg/kg(or 7.5mg/kg),intravenous infusion, 21 days 1 cycle, up to 22 cycles or unacceptable side effects；
WJB001 Capsules:120mg/160mg ( (or referring to previously conducted cohorts or other clinical studies ),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies (e.g., days 1-4, 8-11, 15-18),Every 21 days; JS207:10mg/kg(or lower dosage),intravenous infusion, 21 days 1 cycle, up to 2 years or unacceptable side effects； Toripalimab:240 mg,intravenous infusion,21 days 1 cycle, up to desease progression or unacceptable side effects；
WJB001 Capsules:40mg (or referring to previously conducted cohorts or other clinical studies ),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies (e.g., days 1-4, 8-11, 15-18),Every 21 days; JS207:10mg/kg(or lower dosage),intravenous infusion, 21 days 1 cycle, up to 2 years or unacceptable side effects Toripalimab:240 mg,intravenous infusion,21 days 1 cycle, up to desease progression or unacceptable side effects Paclitaxel:60 mg/m2, Day 1, day 8, day 15, intravenous infusion, 21 days 1 cycle, up to 6 cycles; Carboplatin:AUC 2mg/ml\*min, Day 1, day 8, day 15, intravenous infusion, 21 days 1 cycle, up to 6 cycles;
Eligibility Criteria
You may qualify if:
- Participants voluntarily participate in this study with full informed consent and sign an informed consent form（ICF）.
- Age ≥ 18 years old, No gender limitation,witih BMI (Body Mass Index) ≥ 18.5.
- Patients diagnosed with Advanced solid tumors confirmed by pathology and/or cytology, must meet the following criteria:
- For the detection of biomarkers such as CCNE1,tumor tissue samples must be provided from the patient
- CCNE1 overexpression confirmed by central laboratory immunohistochemistry (IHC) in tumor tissue
- Have failed or are intolerant to standard treatments or have no available standard treatments options(Applicable to Dose escalation phase)
- For patients with platinum-sensitive or platinum-resistant recurrent advanced high-grade serous ovarian cancer(HGSOC), fallopian tube cancer, or peritoneal cancer, as well as advanced uterine serous carcinoma (USC)
- There is at least one Target lesion that meets the definition of RECIST v1.1 criteria, and the selected target lesion has not received biopsy in the past two weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival time ≥12 week.
- Having Adequate hematologic and organ function, the following laboratory tests should be conducted within 7 days prior to the first administration of the investigational drug (No blood transfusion, without receiving hematopoietic stimulating factors or human albumin preparations within 14 days prior to the examination):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
- Hemoglobin\>90 g/L
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN)(for patients with liver metastases ，AST and ALT≤ 5.0× ULN)
- Total bilirubin (TBIL) ≤ 1.5 × ULN(for patients enrolled in Arm A，Arm C and Arm G , TBIL≤ 1.2.5× ULN；patients with Gilbert's Syndrome，TBIL≤3×ULN and Direct bilirubin≤ 1.5 × ULN)
- +3 more criteria
You may not qualify if:
- General condition.
- Pregnant or lactating women
- Any known allergies to or contraindications to components of the study drug
- History of substance abuse
- 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:
- Previous or current treatment with Wee1 inhibitors,as well as CDK2, PKMYT1, PARG, and ATR inhibitors
- Having received cytotoxic chemotherapy drugs, traditional Chinese medicine treatment indicated for anti-tumor purposes, or other anti-tumor drugs (such as small-molecule targeted therapy, etc.) within 14 days before the first administration of the study treatment; or having received investigational drugs, macromolecular drugs with anti-tumor effects (such as monoclonal antibodies, antibody-drug conjugates, or bispecific antibodies, etc.) within 28 days before the first administration of the study treatment; or requiring continued treatment with these drugs during the study period
- Currently using moderate or strong CYP3A inhibitors or inducers, or other products (such as grapefruit juice), or P-gp inhibitors or inducers, and the drug discontinuation time is less than 5 half-lives of the drug or 14 days (whichever is shorter) before the first administration of WJB001
- Known with having a organ transplant or stem cell transplant; Having major surgery or severe trauma (excluding needle biopsy for sample collection) within 4 weeks prior to the first administration of study drug;Minor surgery within 7 days before the first dose, excluding the placement of vascular infusion devices;
- Radiation therapy was administered within 21 days prior to the first administration of study drug, except for cases where radiation therapy is less than or equal to 5% of bone marrow volume, and regardless of when radiation therapy was received, the patients can be included in the study;Any local treatment for cancer such as thoracoabdominal perfusion therapy was received within 14 days before the first administration
- Poorly controlled pleural effusion, ascites, or pericardial effusion (poor control is defined as requiring puncture and drainage during the screening period or having undergone drainage within 3 months before the first dose of medication)
- Patients with a history of drug-related adverse events leading to permanent discontinuation during previous treatment with anti-PD-(L)1 antibodies or analogs or other therapies targeting the same pathway; (applicable only to Arm F and/or Arm G)
- Patients with a history of drug-related adverse events leading to permanent discontinuation during previous treatment with anti-VEGF monoclonal antibodies or analogs or other therapies targeting the same pathway; (applicable only to Arm E, F, and/or Arm G)
- Having received any live vaccine or live-attenuated vaccine within 28 days prior to the first dose, or anticipated to require such vaccination during the study period
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530000, China
Sun Yat-sen Hospital, Sun Yat-sen University
Guangzhou, Gunagdong, 510000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430023, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2025
First Posted
May 1, 2025
Study Start
July 10, 2025
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
December 30, 2029
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share