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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

July 10, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

December 30, 2029

Conditions
Advanced Solid Tumor
Interventions
DRUG

Paclitaxel/Paclitaxel-albumin

"WJB001 Capsules:120mg(or 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

Carboplatin/Nedaplatin

"WJB001 Capsules: 80mg(or 60mg,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

Paclitaxel+Carboplatin

"WJB001 Capsules: 40mg,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

Niraparib

"WJB001 Capsules: 120mg(or 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

Bevacizumab

"WJB001 Capsules: 120mg(or 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;"

Trial Locations (10)

100021

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

110000

RECRUITING

The First Affiliated Hospital of China Medical University, Shenyang

110001

ENROLLING_BY_INVITATION

Liaoning Cancer Hospital, Shenyang

310000

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

350000

RECRUITING

Fujian Cancer Hospital, Fuzhou

410000

RECRUITING

Hunan Cancer Hospital, Changsha

430023

RECRUITING

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

510000

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

RECRUITING

Sun Yat-sen Hospital, Sun Yat-sen University, Guangzhou

530000

RECRUITING

Tumor Hospital Affiliated to Guangxi Medical University, Nanning

All Listed Sponsors
lead

Wigen Biomedicine Technology (Shanghai) Co., Ltd.

INDUSTRY