This is a single-arm, Phase 2 clinical trial (PERSEUS TRIAL / LACOG 1924) evaluating the efficacy, safety, and tolerability of sacituzumab tirumotecan (sac-TMT; MK-2870) as a second-line treatment for patients with advanced or metastatic penile cancer. Penile squamous cell carcinoma (PSCC) is a rare and aggressive cancer with limited treatment options once disease progression occurs after initial platinum-based chemotherapy. Sacituzumab tirumotecan is an antibody-drug conjugate (ADC) designed to target TROP-2, a protein frequently expressed at high levels on penile cancer cells. By binding to TROP-2, sac-TMT delivers a anti-cancer payload directly to the tumor cells. All participants in this trial will receive sacituzumab tirumotecan administered via intravenous (IV) infusion every 2 weeks. The main goal of this study is to determine the percentage of patients whose tumors shrink or disappear after receiving sacituzumab tirumotecan (Objective Response Rate).
Penile squamous cell carcinoma (PSCC) represents a significant unmet medical need, particularly in low- and middle-income regions where the incidence is higher. For patients with disease recurrence or metastasis following first-line platinum-based chemotherapy, standard second-line therapeutic options offer poor response rates and a dismal median overall survival of 4 to 5 months. Recent findings show that over 80% of PSCC cases express high levels of TROP-2, making it a key therapeutic target. Sacituzumab tirumotecan (sac-TMT; MK-2870) is a novel antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 monoclonal antibody linked to a topoisomerase I inhibitor payload (KL610023). Study Design \& Intervention: This is an open-label, multicenter, single-arm Phase 2 trial enrolling 37 adult patients with advanced/metastatic PSCC who experienced disease progression on or after first-line platinum-based chemotherapy. Participants receive sacituzumab tirumotecan at a dose of 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of every 28-day cycle for up to 8 cycles, or until disease progression, unacceptable toxicity, or consent withdrawal. Primary Endpoint: Objective Response Rate (ORR), defined as the proportion of participants achieving a confirmed Complete Response (CR) or Partial Response (PR) assessed by the investigator using RECIST v1.1 criteria. Secondary Endpoints:Independent Central Review Objective Response Rate (ORR-ICR) Disease Control Rate (DCR) and Clinical Benefit Rate (CBR at 24 weeks) Duration of Response (DoR) Progression-Free Survival (PFS) and Overall Survival (OS) Safety and toxicity profile (evaluated via CTCAE v5.0) Treatment compliance and post-progression therapies Exploratory Research: Assessment of baseline tumor TROP-2 expression, HPV16 status, ctDNA dynamics, and molecular mechanisms of acquired resistance. Statistical Design: The trial utilizes Simon's two-stage Minimax design (18 participants accrued in Stage 1, expanding to 33 total evaluable participants if $\\ge5$ responses are observed). Accounting for a 10% drop-out rate, a total of 37 participants will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Sacituzumab tirumotecan is an ADC consisting of 3 major components: 1) a humanized antihuman TROP2 mAb of IgG1 class; 2) an ADC-coupling linker with a methyl sulfonyl moiety as the leaving group; and 3) a cytotoxic drug in the class of topoisomerase 1 inhibitors, KL610023. The drug-antibody ratio of sacTMT is 7.4. Sacituzumab tirumotecan is designed to enhance the binding between the antibody and linker, which can prolong the half-life of ADC molecules in serum.
Instituto D'Or de Pesquisa e Ensino Ceará
Fortaleza, Ceará, Brazil
ICC - Instituto do Câncer do Ceará
Fortaleza, Ceará, Brazil
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)
Salvador, Estado de Bahia, Brazil
Hospital Sírio-Libanês DF
Brasília, Federal District, Brazil
IEPAM - Instituto de Ensino e Pesquisa da Amazônia
Belém, Pará, Brazil
ISEP - Instituto Santa Joana de Ensino e Pesquisa (Rede Américas)
Recife, Pernambuco, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
ISCMPA - Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Futtura Oncologia - Hub de Pesquisa Clínica
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor de Barretos
Barretos, São Paulo, Brazil
...and 1 more locations
Objective Response Rate (ORR) by Investigator Assessment
Percentage of participants who achieve a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 8 cycles (each cycle is 28 days)
Objective Response Rate by Independent Central Review (ORR-ICR)
Percentage of participants who achieve a confirmed CR or PR as assessed by Independent Central Review using RECIST v1.1.
Time frame: Up to 8 cycles (each cycle is 28 days)
Disease Control Rate (DCR)
Percentage of participants who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by the investigator using RECIST v1.1
Time frame: Up to 8 cycles (each cycle is 28 days)
Clinical Benefit Rate (CBR)
Percentage of participants who achieve CR, PR, or SD lasting for at least 24 weeks from enrollment, as assessed by the investigator using RECIST v1.1.
Time frame: At 24 weeks
Duration of Response (DoR)
Time from the first documented evidence of confirmed response (CR or PR) until disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time from the date of enrollment until the first documented disease progression (per RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to 36 months
Overall Survival (OS)
Time from the date of enrollment to the date of death due to any cause.
Time frame: Up to 36 months
Incidence and Severity of Adverse Events (Safety and Toxicity)
Rate of overall treatment-emergent adverse events (TEAEs) and Grade 3 or higher adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Time frame: From baseline up to 30 days after the last dose of study intervention.
Treatment Compliance
Number and percentage of participants whose treatment was reduced, delayed, or permanently discontinued, categorized by reason (e.g., tumor progression, adverse events, or withdrawal of consent).
Time frame: Up to 8 cycles (each cycle is 28 days)
Post-Progression Therapies
Descriptive summary of subsequent anti-cancer therapies administered after disease progression on sacituzumab tirumotecan.
Time frame: Up to 36 months
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