A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors

Sponsor
Wigen Biomedicine Technology (Shanghai) Co., Ltd.
Study ID
NCT06953323
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • WJB001 Capsules+Paclitaxel/Paclitaxel-albumin — DRUG
    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+carboplatin/Nedaplatin — DRUG
    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+Paclitaxel+carboplatin — DRUG
    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+Niraparib — DRUG
    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+Bevacizumab — DRUG
    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+JS207/JS001 — DRUG
    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+Paclitaxel+carboplatin+JS207/Toripalimab — DRUG
    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;

Study Details

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）.

Key Dates

Start date
Jul 10, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
86 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: WJB001 capsules with Taxanes
    If 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.
  • Experimental: WJB001 capsules with Platinum
    If 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.
  • Experimental: WJB001 capsules with paclitaxel+carboplatin
    If 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.
  • Experimental: WJB001 capsules with PARPi
    If 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.
  • Experimental: WJB001 capsules with VEGFi
    If 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.
  • Experimental: WJB001 capsules with Anti-PD-1 and VEGF bispecific antibodies/ Anti-PD-1 antibodies
    If 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.
  • Experimental: WJB001 capsules with paclitaxel and carboplatin, together with Anti-PD-1 and VEGF bispecific antibo
    If 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 .

Primary Outcome Measure

Dose limited toxicity (DLT) [ Time Frame: 21day ]

Central Contacts

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