A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-12

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors

NCT04118114

Gastric Cancer Hepatocellular Carcinoma Advanced Solid Tumor

RECRUITING PHASE2

Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients

NCT07290088

Advanced Solid Cancers

RECRUITING PHASE2/PHASE3

A Phase II Clinical Study of Treprilimab in the Treatment of Recurrent Nasopharyngeal Carcinoma After Re-irradiation

NCT04534855

Nasopharyngeal Carcinoma

UNKNOWN PHASE2

GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors

NCT06265025

Head and Neck Cancer Malignant Melanoma Colorectal Cancer +3 more

RECRUITING PHASE1/PHASE2

A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors

NCT04996121

Locally Advanced or Metastatic Solid Tumors Locally Advanced or Metastatic Non-small Cell Lung Cancer

RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV) infusion till patient meets any of the discontinuation criteria (progressive disease, clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PRL3-zumab

All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.

Group Type EXPERIMENTAL

PRL3-zumab

Intervention Type BIOLOGICAL

Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRL3-zumab

Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with unresectable or metastatic solid tumors willing to provide signed informed consent.
* Histopathological diagnosis and metastatic status cancer at study entry.
* Must have received at least 1 prior line of systemic therapy for metastatic disease but no more than 3 prior lines of treatment for metastatic disease.
* Life expectancy of more than 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score or less than 2.
* Adequate organ and hematological function.
* Measurable disease by RECIST v1.1 and iRECIST.

Exclusion Criteria

* Patient has known untreated or symptomatic central nervous system metastasis.
* Patient is receiving systemic glucocorticoids or other immunosuppressive treatments for autoimmune disease or any other medical condition.
* Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody.
* Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment.
* Patient has undergone radiotherapy ≤ 4 weeks prior to starting study treatment.
* Patient has received \> 3 lines of prior systemic chemotherapy for metastatic disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No