NCT07290088: PRL3-zumab

An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumor Patients

Recruiting now Phase 2/Phase 3 Last updated 14 April 2026

What this trial tests

Phase 2/Phase 3 trial testing PRL3-ZUMAB in Advanced Solid Cancers in 52 participants. Currently enrolling.

Timeline

9 January 2023

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	Intra-IMMUSG Pte Ltd
Phase	Phase 2/Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	9 January 2023
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	4 locations across Malaysia

Drugs / interventions tested

• PRL3-ZUMAB — full drug profile →

Conditions studied

• Advanced Solid Cancers — all drugs for Advanced Solid Cancers →

Sponsor

Intra-IMMUSG Pte Ltd — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Solid Cancers. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression free survival (PFS)
  Time frame: Time Frame: From the date of first dose of study drug until first documented disease progression or date of death from any cause, whichever comes first, assessed up to 12 months.
  PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria.
• Time to Progression (TTP)
  Time frame: From the date of first dose of study drug until first documented disease progression, assessed up to 12 months.
  TTP is defined as the time from the the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria which does not include deaths.

Sponsor's own description

This is a Multi-Center, Phase II/III, open-label, single dose level (6 mg/kg) basket trial of PRL3-zumab monotherapy in solid cancer patients.

The study will consist of a Screening Period (Day - 14 to Day -1) for completion of all screening assessments before the first administration of study treatment, a Treatment Period during which visits will occur every 2-week (PK T1/2 = 12 days ±2 days), once the decision to discontinue treatment for any reason, an End of Treatment (EOT) visit will be performed within 14 days ±4 days after last dose of study treatment. Safety Follow-up/EOS visit will be performed 28 days ±2 days after last dose of study treatment and survival follow-up call will be performed every month up to 6 months after EOS visit.

PRL3-zumab will be administered by intravenous (i.v.) infusion till patient meets discontinuation criteria (progressive disease, clinically or per iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4-weeks (2 infusions, 12 days±2 days apart). Patients will undergo safety assessment including laboratory tests prior to each infusion. Efficacy will be assessed by iRECIST at baseline and every 4 doses after study treatment. QoL assessments will be performed at Screening and every 4 doses ±7 days during treatment. A patient will be discontinued from study treatment if the patient progress clinically or per iRECIST criteria, or for intolerable toxicity, or if the patient withdraws consent. An EOT visit will be performed within14 days ±4 days after last study treatment dose.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.