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Monoclonal Antibodies

PRS-344/S095012 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Servier Bio-Innovation LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient with no available archived material must have one or more tumor lesions amenable to biopsy

Age ≥18 years on the day the consent is signed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion up to 24 months

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating patients with advanced solid tumors.

Who is the study for?

Adults (≥18 years) with advanced or metastatic solid tumors that standard treatments can't help anymore are eligible for this trial. They must have at least one measurable tumor, be in good physical condition (ECOG 0-1), and women must use effective birth control. Patients who've had major surgery recently, unstable brain metastases, or recent other cancer therapies may not qualify.Check my eligibility

What is being tested?

The study is testing PRS-344/S095012, a new drug designed to treat various solid tumors. It's an early-stage trial to see how safe the drug is and what doses are tolerable when given to people whose cancers haven't responded to standard treatments.See study design

What are the potential side effects?

As this is a first-in-human study of PRS-344/S095012, specific side effects aren't yet known but could include typical reactions related to immune-based cancer therapies such as fatigue, infusion reactions, organ inflammation, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can have a biopsy because I don't have previous tissue samples.

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I am 18 years old or older.

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My condition worsened after my last treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is advanced, cannot be surgically removed, and standard treatments don't work or can't be used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anti-tumor activity

Safety Measurements

Safety measurements

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRS-344/S095012Experimental Treatment1 Intervention

PRS-344/S095012

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Institut de Recherches Internationales ServierOTHER

86 Previous Clinical Trials

67,006 Total Patients Enrolled

Servier Bio-Innovation LLCLead Sponsor

6 Previous Clinical Trials

527 Total Patients Enrolled

Pieris Pharmaceuticals, Inc.Lead Sponsor

3 Previous Clinical Trials

206 Total Patients Enrolled

Media Library

PRS-344/S095012 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05159388 — Phase 1 & 2

Solid Tumors Research Study Groups: PRS-344/S095012

Solid Tumors Clinical Trial 2023: PRS-344/S095012 Highlights & Side Effects. Trial Name: NCT05159388 — Phase 1 & 2

PRS-344/S095012 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159388 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this clinical experiment?

"According to the clinical trials registry, this medical study is open for enrolment. It was first published on September 8th 2021 and recently updated in June of 2022."

Answered by AI

What is the cumulative amount of participants within this research investigation?

"Affirmative. According to clinicaltrials.gov, the experiment that was initially advertised on September 8th 2021 is still actively seeking participants. 2 different medical centres are looking for 130 people in total to take part in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

2021. "A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05159388.