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A study of PRS-344/S095012 (PD-L1x4-1BB bispecific antibody) in patients with solid tumors
EU CTIS ID: 2023-510046-25-00
What this study is testing
Phase 1: - To evaluate the safety and tolerability profile of single-agent PRS-344/S095012 - To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended phase 2 dose (RP2D) of PRS-344/S095012 Phase 2: To evaluate the potential anti-tumor activity and efficacy of PRS-344/S095012, as per central assessment according to RECIST v1.1 criteria based on appropriate clinical standards for the specified tumor type
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years on the day the consent is signed.
- Negative test results for human T-lymphotropic virus 1 (HTLV 1). HTLV testing is only required for participants from countries in which HTLV 1 infection is endemic (Japan, countries in the Caribbean basin,South America, Central America, sub-Saharan Africa, and Melanesia).
- Dose Escalation: Patients with a histological diagnosis of an unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
- Dose Escalation: Patients must have measurable disease per RECIST 1.1 as assessed by the local site investigator/imaging. Lesions situated in a previously irradiated area are considered measurable only if progression has been demonstrated in such lesions.
- Dose Escalation:Patients with no available archived material must have one or more tumor lesions amenable to biopsy
- Dose Expansion: Patients with histologically diagnosed Arm 1 and 2: recurrent, persistent, and/or metastatic cervical cancer. Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma. Arm 3: locally advanced or metastatic cutaneous squamous cell carcinoma.
You likely can't join if
- 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: a. Chemotherapy, small molecule inhibitors, monoclonal antibodies, antibody-drug conjugates, and/or other similar investigational agent: at least 3 weeks or 5 half-lives prior to first IMP administration, whichever is shorter. b. Radioimmunoconjugates or other similar experimental therapies at least 6 weeks or 5 half-lives prior to first IMP administration, whichever is shorter.
- Patients who have received a 4-1BB agonist in the past.
- Patients who had a major surgery within 4 weeks prior to first administration of IMP.
- Patients who have received either systemic corticosteroids (> 10 mg per day or equivalent) or other immunosuppressive medications during the 2 months prior to the first dose of the study drug. Higher single doses of corticosteroids given as premedication against infusion-related reactions are allowed. Treatment with local steroids (inhaled, intranasal, injected are allowed.
- Patients with an active infection with a viral, bacterial, or fungal pathogen requiring systemic treatment within seven days before first IMP administration.
See the full eligibility criteria
Who can join
- Age ≥18 years on the day the consent is signed.
- Negative test results for human T-lymphotropic virus 1 (HTLV 1). HTLV testing is only required for participants from countries in which HTLV 1 infection is endemic (Japan, countries in the Caribbean basin,South America, Central America, sub-Saharan Africa, and Melanesia).
- Dose Escalation: Patients with a histological diagnosis of an unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
- Dose Escalation: Patients must have measurable disease per RECIST 1.1 as assessed by the local site investigator/imaging. Lesions situated in a previously irradiated area are considered measurable only if progression has been demonstrated in such lesions.
- Dose Escalation:Patients with no available archived material must have one or more tumor lesions amenable to biopsy
- Dose Expansion: Patients with histologically diagnosed Arm 1 and 2: recurrent, persistent, and/or metastatic cervical cancer. Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma. Arm 3: locally advanced or metastatic cutaneous squamous cell carcinoma.
- Dose Expansion: Patients must have received : Arm 1 (cervical , CPI-naïve): at least 1 prior line of platinum-based combination therapy. Patients must not have received any prior treatment with an immune checkpoint inhibitor (anti-PD-1, PD-L1 or anti-CTLA-4 [cytotoxic T lymphocyte-associated protein 4]) and do not have access to an approved immune checkpoint inhibitor. Surgery, radiation therapy, and additional chemotherapy must not be considered appropriate alternative treatment options for these patients. Arm 2 (cervical cancer, CPI-relapsed/refractory): at least 1 prior line of systemic therapy with an immune checkpoint inhibitor as monotherapy or in combination with chemotherapy and/or any other systemic therapies. Surgery, radiation therapy, and additional chemotherapy must not be considered appropriate lternative treatment options for these patients. Arm 3 (CSCC, CPI-relapsed/refractory): at least 1 prior line of systemic therapy with an immune checkpoint inhibitor as monotherapy or in combination with chemotherapy and/or any other systemic therapies. Surgery, radiation therapy, and additional chemotherapy must not be considered appropriate alternative treatment options for these patients.
- Dose Expansion: Biopsy requirements Arms 1 and 2 (cervical cancer): fresh baseline biopsies are mandatory, on-treatment biopsies are optional. Arm 3 (skin cancer): fresh baseline biopsies are mandatory, on-treatment biopsies are mandatory unless medically contra-indicated.
- Dose Expansion: Patients must have at least one measurable target lesion as per RECIST 1.1 and/or World Health Organization (WHO) criteria for only externally visible skin tumors confirmed by central review. Lesions situated in a previously irradiated area are considered measurable only if progression has been demonstrated in such lesions
- Patient must have a life expectancy of at least 3 months.
- Patient should have a documented disease progression on prior therapy before entry into this study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis).
- Adequate organ function as assessed by laboratory tests within 7 days prior to pretreatment with obinutuzumab: -Lymphocyte count ≥ 800/μ -Gamma-globulin level > 6g/L (by serum protein electrophoresis) or IgG level > 4g/L (by measurement of quantitative immunoglobulins)
- A female patient must use a highly effective method of birth control during study treatment and until, for 120 days after the last dose of the study treatment. PRS-344/S095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest.
- A male patient with childbearing potential partners must use a condom during the study and for at least 4 months after the last dose of the study treatment, or 6 months after the last Obinutuzumab infusion, whichever comes the latest. Sperm donation will not be allowed during the study and for 4 months after the last dose of study treatment, or 6 months after the last obinutuzumab infusion, whichever comes the latest.
- Test should be negative for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) infection, according to local standards: - Negative CMV DNA testing in serum or plasma by a sensitive quantitative molecular method. - Absence of immunoglobulin (Ig)M antibodies against EBV-VCA (Viral Capside Antigen) - Negative serologic testing for hepatitis B surface antigen (HbsAg) or a negative result by a sensitive quantitative molecular method for HBVDNA in serum or plasma -Negative HCV RNA testing in serum or plasma by a sensitive quantitative molecular method.
What rules you out
- 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: a. Chemotherapy, small molecule inhibitors, monoclonal antibodies, antibody-drug conjugates, and/or other similar investigational agent: at least 3 weeks or 5 half-lives prior to first IMP administration, whichever is shorter. b. Radioimmunoconjugates or other similar experimental therapies at least 6 weeks or 5 half-lives prior to first IMP administration, whichever is shorter.
- Patients who have received a 4-1BB agonist in the past.
- Patients who had a major surgery within 4 weeks prior to first administration of IMP.
- Patients who have received either systemic corticosteroids (> 10 mg per day or equivalent) or other immunosuppressive medications during the 2 months prior to the first dose of the study drug. Higher single doses of corticosteroids given as premedication against infusion-related reactions are allowed. Treatment with local steroids (inhaled, intranasal, injected are allowed.
- Patients with an active infection with a viral, bacterial, or fungal pathogen requiring systemic treatment within seven days before first IMP administration.
- Patients with a history of an opportunistic infection within a year prior to first IMP administration
- History of progressive multifocal leukoencephalopathy.
- Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Australia
- United States
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Australia; United States; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.