Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
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.
Conditions
This trial is treating people with advanced or metastatic solid cancer
Eligibility
Inclusion
- Age ≥18 years on the day the consent is signed.
- 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.
- Patient should have a documented disease progression on prior therapy before entry into this study.
- Patients must have at least one measurable target lesion as per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
- Adequate organ function as assessed by laboratory tests within 72 hours prior to the start of treatment.
- 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.
Exclusion
- 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.
-
Patients who have received prior:
- Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
- Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.
- Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter.
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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
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