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Monoclonal Antibodies
PRL3-zumab for Solid Tumors
Phase 2
Waitlist Available
Research Sponsored by Intra-IMMUSG Pte Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and during first dose of c1, pre dose c1d15, c2d1, c2d15, c3d1, and pre dose and during the second dose of c3, pre-dose c4d1, c5d1, c6d1 and at end of treatment (up to approximately 6 months). duration of 1 cycle is 4 weeks. c = cycle, d = day.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests PRL3-zumab, a medicine given alone through an IV, in patients with tumors that can't be removed by surgery or have spread. The treatment involves regular infusions to help manage the cancer.
Who is the study for?
This trial is for patients with solid tumors that can't be surgically removed or have spread, who've had at least one but no more than three treatments for metastatic disease. They should be relatively active (ECOG score ≤2), expect to live more than six months, and not currently on immunosuppressants or have had recent cancer treatment.
What is being tested?
The study tests PRL3-zumab as a single therapy in people with advanced solid tumors. It's an open-label Phase 2 trial, meaning both researchers and participants know what treatment is being given, and it involves just one dose level of the drug.
What are the potential side effects?
While specific side effects are not listed here, monoclonal antibodies like PRL3-zumab could potentially cause allergic reactions, fatigue, nausea, diarrhea, blood count changes and increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose and during first dose of c1, pre dose c1d15, c2d1, c2d15, c3d1, and pre dose and during the second dose of c3, pre-dose c4d1, c5d1, c6d1 and at end of treatment (up to approximately 6 months). duration of 1 cycle is 4 weeks. c = cycle, d = day.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and during first dose of c1, pre dose c1d15, c2d1, c2d15, c3d1, and pre dose and during the second dose of c3, pre-dose c4d1, c5d1, c6d1 and at end of treatment (up to approximately 6 months). duration of 1 cycle is 4 weeks. c = cycle, d = day.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit rate (CBR)
Duration of response
Objective response rate (ORR)
+2 moreSecondary study objectives
Area under the concentration time curve from pre-dose (AUCinf)
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PRL3-zumabExperimental Treatment1 Intervention
All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.
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Who is running the clinical trial?
ParexelIndustry Sponsor
311 Previous Clinical Trials
101,500 Total Patients Enrolled
Intra-IMMUSG Pte LtdLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a very bad allergic reaction to another type of medication called monoclonal antibody.You are expected to live for at least 6 more months.You have cancer that has spread to your brain and it is causing symptoms or hasn't been treated yet.You have received radiation therapy within the past 4 weeks before starting the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: PRL3-zumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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