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

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）.

Conditions

• Advanced Solid Tumor

Interventions

DRUG

WJB001 Capsules+Paclitaxel/Paclitaxel-albumin

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

DRUG

WJB001 Capsules+carboplatin/Nedaplatin

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;

DRUG

WJB001 Capsules+Paclitaxel+carboplatin

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;

DRUG

WJB001 Capsules+Niraparib

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;

DRUG

WJB001 Capsules+Bevacizumab

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；

DRUG

WJB001 Capsules+JS207/JS001

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；

DRUG

WJB001 Capsules+Paclitaxel+carboplatin+JS207/Toripalimab

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;

Sponsors & Collaborators

• Wigen Biomedicine Technology (Shanghai) Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-10

Primary Completion

2029-06-30

Completion

2029-12-30

Countries

• China

Study Locations