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Study of PRS-344/S095012 and obinutuzumab combination for patients with solid tumors - First human trial to evaluate safety and effectiveness

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates a new treatment approach for patients with solid tumors. The research focuses on testing two medications: PRS-344/S095012 and Gazyvaro (also known as obinutuzumab). These medications are given through intravenous administration, which means they are delivered directly into the bloodstream through a vein.

The study aims to evaluate how safe and effective these medications are for treating various types of solid tumors, including cervical cancer and cutaneous squamous cell carcinoma (a type of skin cancer). The research is divided into two phases. The first phase determines the safest and most appropriate dose of the medication, while the second phase examines how well the treatment works in fighting the cancer.

During the study, participants receive the study medications through regular infusions. The treatment continues until either the disease progresses or the patient experiences unacceptable side effects. Throughout the study, doctors monitor patients' health through various medical examinations and tests to evaluate how well the treatment is working and to check for any side effects. The study also looks at how the medications move through the body and whether patients develop antibodies against the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical evaluation

    Your medical condition will be assessed to confirm the presence of solid tumors that can be measured.

    Laboratory tests will be performed to check organ function and screen for various viruses including CMV, EBV, hepatitis B, and hepatitis C.

    Your performance status will be evaluated using the ECOG scale (a measure of your ability to perform daily activities).

  2. Step 2

    Treatment preparation

    A tumor biopsy will be collected before starting treatment.

    Your doctor will review your previous treatments and confirm disease progression.

  3. Step 3

    Treatment administration

    You will receive two medications through intravenous infusion:

    - PRS-344/S095012 (400mg/16ml concentrate solution)

    - Gazyvaro (1,000 mg concentrate solution)

    The treatment will continue as long as it provides benefit and is well-tolerated.

  4. Step 4

    Monitoring during treatment

    Regular assessments will include:

    - Blood tests to check organ function

    - Heart monitoring (ECG)

    - Vital signs measurements

    - Imaging scans to measure tumor response

    Side effects will be monitored throughout the treatment period.

  5. Step 5

    Follow-up period

    After completing treatment, you will be monitored for:

    - Response to treatment

    - Disease progression

    - Long-term side effects

    Female patients must use birth control for 120 days after the last dose or 18 months after the last Gazyvaro infusion, whichever is longer.

    Male patients must use birth control for 4 months after the last dose or 6 months after the last Gazyvaro infusion, whichever is longer.

Who can join the trial?

13 criteria

  • Must be at least 18 years old when signing the consent form
  • Must test negative for HTLV-1 (a type of virus) if coming from certain regions where this virus is common
  • Must have an advanced or spreading solid tumor that cannot be surgically removed, and standard treatments are either not available, not working, or cannot be tolerated
  • Must have tumors that can be measured by imaging scans
  • Must be able to provide tumor tissue samples for testing, either from previous procedures or through new biopsies
  • Must have at least 3 months of expected survival time
  • Must show that previous cancer treatments were not effective
  • Must have good physical function, scoring 0 or 1 on the ECOG scale (a measure of daily living abilities)
  • Must have good overall health status, scoring 0 or 1 on the Royal Marsden Prognosis score (measures certain blood test results)
  • Must have adequate organ function shown by specific blood test results
  • Female participants must use effective birth control during the study and for 120 days after treatment ends
  • Male participants must use condoms during the study and for at least 4 months after treatment ends
  • Must test negative for several viruses including CMV, EBV, Hepatitis B, and Hepatitis C

Who cannot join the trial?

13 criteria

  • Prior organ transplant or currently receiving immunosuppressive therapy
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Uncontrolled high blood pressure or heart disease
  • Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • Known infection with HIV, active hepatitis B, or hepatitis C
  • Other active cancers requiring treatment (except for certain skin cancers or in situ cervical cancer)
  • Major surgery within 4 weeks before starting the study treatment
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to biological treatments
  • Participation in another clinical trial within 4 weeks before this study
  • Significant liver or kidney function problems
  • Any condition that, in the investigator's opinion, would compromise the patient's safety or study participation
  • Unable to understand or provide informed consent
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Investigated drugs

PRS-344/S095012 is an investigational drug being studied in patients with solid tumors. It is a novel treatment that is being tested for the first time in humans (first-in-human study). This medication is being evaluated to understand how safe it is and how well patients tolerate it when given alone. The researchers are studying different doses of this drug to find the most appropriate dose that can be used for future treatments.

What is already known about the treatment

PRS-344/S095012 - This investigational medication is currently undergoing Phase 1/2 clinical trials for the treatment of solid tumors. It is administered as a single-agent therapy, with the primary focus on establishing its safety profile, optimal dosing, and potential anti-tumor activity. The clinical trial aims to determine both the maximum tolerated dose and the recommended Phase 2 dose through a multicenter, open-label study approach. While the exact molecular mechanism of action is not specified in the source data, this experimental drug is being evaluated for its therapeutic efficacy against various types of solid tumors, with treatment response being assessed according to RECIST v1.1 criteria.

Investigated diseases

Solid Tumors - A condition where abnormal masses of tissue (tumors) form in various parts of the body, excluding blood cancers. These growths develop when cells divide uncontrollably and form a lump or mass of tissue that can occur in organs, bones, muscles, or other body tissues. Solid tumors can be benign (non-cancerous) or malignant (cancerous), with malignant tumors having the ability to grow and potentially spread to other parts of the body. The growth pattern and characteristics vary depending on the location and type of cells involved. These tumors can develop in any age group and may affect various body systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-510046-25-00Protocol codeCL1-95012-001Estimated enrolment277 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

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