NCT05326035

A Study of WJ05129 in Advanced Malignant Solid Tumors

Terminated Phase 1, PHASE2 Last updated 2 October 2025

What this trial tests

Phase 1, PHASE2 trial testing WJ05129 in Locally Advanced or Metastatic Malignant Solid Tumors in 26 participants. Terminated before completion.

Timeline

19 April 2022

Primary endpoint
26 December 2023

26 December 2023

Quick facts

Lead sponsor	Suzhou Junjing BioSciences Co., Ltd.
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	19 April 2022
Primary completion	26 December 2023
Estimated completion	26 December 2023
Sites	1 location across China

Drugs / interventions tested

• WJ05129 — full drug profile →
• Paclitaxel injection — full drug profile →

Conditions studied

• Locally Advanced or Metastatic Malignant Solid Tumors — all drugs for Locally Advanced or Metastatic Malignant Solid Tumors →

Sponsor

Suzhou Junjing BioSciences Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Locally Advanced or Metastatic Malignant Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was an open, multicenter Phase I/II clinical study of WJ05129 in patients with locally advanced or metastatic malignant solid tumors in China, which was divided into three stages: Single-dose escalation,Combined dose extension and efficacy extension. The study included screening, treatment and follow-up periods. The starting dose of this dose-escalation study was set at 2.5 mg/day. Five dose levels were preset.A more flexible "BOIN" dose escalation method was adopted. The maximum tolerated dose observation period was the first treatment cycle of single administration and multiple consecutive administrations (a total of 2 days) + 21 days = 23 days; In this stage, the two dosage levels of the injectable WJ05129 (RP2D dosage and the lower dose before RP2D) will be selected as the escalating doses for the combined use of WJ05129. The "BOIN" design will be adopted for dose escalation. Paclitaxel 80mg/m2 will be intravenously infused on days 1, 8, and 15. A 28-day cycle will be used, with the first cycle being the DLT observation period.Efficacy expansion phase: It is preliminarily planned to expand three cohorts of Rb negative TNBC and SCLC andOther solid tumors（Such as gastric and esophageal adenomas, gynecological tumors, etc.）, and recruit about 20-40 people in each cohort.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A new wave of innovations within the DNA damage response.
   Li Q, Qian W, Zhang Y, Hu L, et al · · 2023 · cited 85× · PMID 37679326 · DOI 10.1038/s41392-023-01548-8