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RecruitingLast updated: 2 February 2024

CL1-95012: This phase I/II study is trying to determine the best dose level and safety of a new treatment drug (PRS-344/S095012) in people with advanced or metastatic solid cancersA First in Human Phase 1-2 Open-Label, Multicenter, Dose Escalation and Expansion Study of PRS-344/S095012 in Patients With Solid Tumors

Clinical summary


This study consists of two parts, a dose escalation part (phase I) and n expansion part (phase II). The expansion part will be initiated once the optimal biological dose (OBD) has been determined in phase I. PRS-344/S095012 will be administered as monotherapy.


This trial is treating patients with advanced or metastatic solid cancer


Multi-Cancer Multi-Cancer





Trial Acronym


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Trial Identifiers

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Trial sponsor

Pieris Pharmaceuticals, Inc.

Scientific Title

A First in Human Phase 1-2 Open-Label, Multicenter, Dose Escalation and Expansion Study of PRS-344/S095012 in Patients With Solid Tumors



  1. Age ≥18 years on the day the consent is signed.
  2. Patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
  3. Patient should have a documented disease progression on prior therapy before entry into this study.
  4. Patients must have at least one measurable target lesion as per RECIST 1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
  7. Adequate organ function as assessed by laboratory tests within 72 hours prior to the start of treatment.
  8. A female patient must use a highly effective method of birth control during study treatment and until 120 days after last dose of study treatment.


  1. Patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. Low dose of steroid <10 mg/day prednisone or equivalent) is allowed.
  2. Patients who have received prior:

    1. Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
    2. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.
    3. Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter.
  3. Patients who have received 4-1BB agonists in the past.
  4. Patients who had a major surgery within 4 weeks prior to first administration of IMP.


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.


  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

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Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.


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