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A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors

NCT05773820 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-04-01

No results posted yet for this study

Summary

This is a phase I/II study to evaluate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJB001 capsules in patients with advanced solid tumors, including dose escalation phase, dose expansion phase and cohort expansion phase.The study includes screening, treatment and follow-up periods.

In the Dose Escalation phase:Accelerated titration (the first two dose groups) and "BOIN" combination (the subsequent dose group) were used for dose escalation.

In the Dose Expansion phase:Based on the previous data, 1 to 2 doses were selected to further evaluate the initial efficacy, safety, tolerability and pharmacokinetic characteristics to confirm RP2D.

In the Efficacy Expansion phase:The preliminary plan of Efficacy expansion phase uses the Simon two-stage optimal method to expand 2 to 3 cohorts.

Conditions

Interventions

DRUG

WJB001

WJB001 Capsules:160mg(or othe dosages),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies,Every 21 days

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

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

    lead INDUSTRY

Principal Investigators

  • Lingying Wu, Professor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2026-08-08
Completion
2027-05-23

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05773820 on ClinicalTrials.gov