What side effects are associated with this type of intervention?

Common treatments for solid tumors that target specific pathways or receptors, such as immunotherapies and targeted therapies, often have distinct side effects. For example, treatments like nivolumab and ipilimumab can cause immune-related adverse events, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Other targeted therapies may lead to hypertension, hypothyroidism, diarrhea, and fatigue. Hematologic toxicities such as neutropenia and anemia are also common. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several FDA-approved drugs target specific pathways or receptors in the treatment of solid tumors. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors targeting PD-1, approved for various solid tumors including melanoma, non-small cell lung cancer, and renal cell carcinoma. Atezolizumab (Tecentriq) targets PD-L1 and is approved for urothelial carcinoma and non-small cell lung cancer. Additionally, combination therapies like pembrolizumab with lenvatinib (Lenvima) have been approved for advanced endometrial cancer, demonstrating the efficacy of targeting multiple pathways. These approvals highlight the trend towards using targeted immunotherapies in the treatment of solid tumors.

What other types of research exist?

Promising novel alternatives to PRS-344/S095012 for solid tumor patients include: <ol> <li>Pembrolizumab (Keytruda) - an anti-PD-1 therapy showing efficacy in various solid tumors.</li> <li></li> </ol> Atezolizumab (Tecentriq) - an anti-PD-L1 therapy used in combination with other agents for enhanced efficacy. 3. Regorafenib - a multitargeted kinase inhibitor with activity in several solid tumors. 4. Enfortumab Vedotin - an antibody-drug conjugate targeting Nectin-4, showing promise in urothelial carcinoma and other solid tumors. 5. Lutetium-177-PSMA-617 - a radioligand therapy for prostate cancer, potentially applicable to other solid tumors. These therapies represent advanced and targeted approaches in the treatment of solid tumors.

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Monoclonal Antibodies

PRS-344/S095012 for Advanced Cancer

Phase 1 & 2

Waitlist Available

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

Must not have

Patients who have received 4-1BB agonists in the past

Patients who had a major surgery within 4 weeks prior to first administration of IMP.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, PRS-344/S095012, in patients with advanced or metastatic solid tumors. It aims to find the safest and most effective dose.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with 4-1BB agonists.

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I had major surgery less than 4 weeks ago.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety Measurements

Secondary study objectives

Detection of anti-drug antibodies (ADA) against PRS-344/S095012

Disease Control (DC)

Duration of Response (DoR)

+8 more

Awards & 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: PRS-344/S095012Experimental Treatment1 Intervention

PRS-344/S095012

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors often involve targeted therapies and immunotherapies. Targeted therapies, such as those inhibiting epidermal growth factor receptor (EGFR) or vascular endothelial growth factor (VEGF), work by blocking specific molecules involved in tumor growth and angiogenesis. Immunotherapies, including immune checkpoint inhibitors like anti-PD-1 or anti-PD-L1 antibodies, enhance the body's immune response against cancer cells. The investigational agent PRS-344/S095012, a bispecific antibody-anticalin fusion, likely combines these approaches by targeting PD-L1 and 4-1BB, aiming to both inhibit tumor immune evasion and stimulate an anti-tumor immune response. These mechanisms are crucial for solid tumor patients as they offer more precise and potentially effective treatment options with the goal of improving outcomes and reducing side effects compared to traditional chemotherapy.