NCT06953323

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Wigen Biomedicine Technology (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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）.

Detailed description

The study is a multicenter,phase I/II clinical trial, divided into three parts: In the Dose Escalation phase(Phase Ia): BOIN design were used to search the Maximum tolerated dose (MTD), allowing to increase or decrease the dose of one or separate drugs in the combination for dosage exploration.Recruitment by Arm, estimate 5 7 cohort, with several dose levels planned for each cohort: In the Arm A/B/C combination therapy, chemotherapy (taxanes, platinum) is administered for a maximum of 6 cycles. After chemotherapy, WJB001 monotherapy is used to maintain treatment until the subject's disease progresses or withdrawl; In the Arm D combination therapy, the PARP inhibitor, such as Niraparib, is administered every 21 days in a cycle until the subject's disease progresses or withdrawl. In the Arm E combination therapy, as an example, Bevacizumab can be treated for a maximum of 22 cycles or unacceptable side effects occur (whichever occurs first), and then Bevacizumab treatment is terminated and maintained with WJB001 monotherapy until the subject's disease progression or withdrawal In the Arm F1 combination therapy, JS207 is treated for 2 years or with unacceptable side effects (whichever occurs first) before disease progression occurs, and then JS207 treatment is terminated. Arm F2/G2: JS001 Treat until unacceptable side effects occur (whichever occurs first) before disease progression occurs.Upon termination of JS207/JS001 treatment, maintenance therapy with WJB001 monotherapy will be administered at a dose of 160 mg or the current dose (as determined by the investigator), until disease progression or withdrawal. In the Arm G combination therapy, chemotherapy (paclitaxel, platinum) is administered for up to 6 cycles,WJB001+JS207/JS001 is maintained at the RP2D dose of the two drugs explored in Arm F or the current dose (determined by Investigator). In the Dose Expansion phase(Phase Ib): 1 to 2 dose levels for each group will be selected the sponsor and the SMC based on the previous data, to further evaluate the preliminary efficacy, safety, tolerability and pharmacokinetic characteristics of the combination therapy in the target population, and confirm the RP2D dose of different combination regimens. Efficacy Expansion Stage(Phase II): At the RP2D regimen determined in the Phase IB study, to explore the efficacy, safety, tolerability and pharmacokinetic characteristics of WJB001 combination therapy in the target population. And 2 to 3 cohorts is preliminarily planned for expansion and the "Simon Two-Stage" design is adopted.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
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;

Timeline

• Start date: 2025-07-10
• Primary completion: 2029-06-30
• Completion: 2029-12-30
• First posted: 2025-05-01
• Last updated: 2026-03-27

Locations

10 sites across 1 country: China