Health TrialsbyHealthPanel

WSK-IM02 in Advanced Solid Tumors With Malignant Effusions (Phase I)

ConditionsAdvanced Solid TumorsMalignant Pleural EffusionsMalignant Ascites
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWestVac Biopharma Co., Ltd.

About this trial

This is a prospective, single-center, interventional, phase I, dose-escalation, single-arm study designed to evaluate the safety, tolerability, and preliminary efficacy of intrapleural/intraperitoneal infusion of WSK-IM02 in patients with advanced solid tumors complicated by malignant pleural or peritoneal effusions who have failed standard of care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years and ≤75 years.

Voluntarily sign informed consent form.

Patients with histologically or cytologically confirmed advanced solid tumors.

Histologically or cytologically confirmed malignant pleural/peritoneal effusion requiring drainage; or, in the absence of histologic/cytologic evidence, pleural effusion with clear imaging evidence of malignant pleural/peritoneal lesions on chest/abdominal CT and diagnosed as malignant pleural/peritoneal tumor in clinical practice.

Disqualifiers

Participation in any other interventional clinical trial within 4 weeks prior to the first dose of study drug.

Received local intracavitary therapy for pleural/peritoneal effusion (excluding diagnostic or symptom-relieving puncture/drainage) within 2 weeks prior to the first dose of study drug.

Received extra-thoracic/extra-abdominal radiotherapy within 2 weeks prior to the first dose of study drug, or received radical radiotherapy to pleural/peritoneal or pulmonary/abdominal lesions within 8 weeks prior to enrollment (palliative radiotherapy to chest/abdomen is permitted).

Underwent major thoracic or abdominal surgery within 4 weeks prior to the first dose of study drug and not fully recovered, or planned to undergo elective major surgery during the study period.

Trial design

Design model

Single group

Treatments tested in this trial

  • WSK-IM02

    Biological/Vaccine

    WSK-IM02 is an injectable pMVA-1 lipid complex

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: intrapleural/intraperitoneal infusion of WSK-IM02Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

adverse events (AE)

Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.

Time frame
up to 28 days

Secondary outcomes

1

Objective response rate (ORR)

ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)

Time frame
up to 12 months
2

Progression-free survival (PFS)

PFS is defined as the time from the administration of the first dose to first disease.

Time frame
up to 12 months
3

Overall survival (OS)

OS is defined as the time from the administration of the first dose to death.

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

WestVac Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: