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

NCT06953323 ↗

Phase 1/2 Recruiting 86 enrolled Wigen Biomedicine Technology (Shanghai) Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

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）.

Timeline

Start
2025-07-10
Primary completion
2029-06-30
Completion
2029-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Carboplatin Small molecule 2 unknown Intravenous
Subject Carboplatin Small molecule 3 unknown Intravenous
Subject Carboplatin Small molecule 4 unknown Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject JS207 Monoclonal antibody 10 mg/kg Intravenous
Subject Nedaplatin Small molecule 60 mg/m2 Intravenous
Subject Nedaplatin Small molecule 80 mg/m2 Intravenous
Subject Nedaplatin Small molecule 100 mg Intravenous
Subject Niraparib Small molecule 100 mg Oral
Subject Niraparib Small molecule 200 mg Oral
Subject Niraparib Small molecule 300 mg Oral
Subject Paclitaxel Small molecule 50 mg/m2 Intravenous
Subject Paclitaxel Small molecule 60 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 180 mg/m2 Intravenous
Subject Paclitaxel Small molecule 220 mg/m2 Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Subject WJB001 Unknown 40 mg Oral
Subject WJB001 Unknown 60 mg Oral
Subject WJB001 Unknown 80 mg Oral
Subject WJB001 Unknown 100 mg Oral
Subject WJB001 Unknown 120 mg Oral
Subject WJB001 Unknown 160 mg Oral

Indications

neoplasm