Penile Squamous Cell CarcinomaPhase 2PERSEUSNCT07815197
Sacituzumab Tirumotecan as Second-Line Treatment for Penile Cancer
A Phase 2 study testing Sacituzumab Tirumotecan in people with Penile Squamous Cell Carcinoma and Metastatic Penile Squamous Cell Carcinoma, run by Latin American Cooperative Oncology Group at 11 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Squamous Cell Carcinoma, Metastatic Penile Squamous Cell Carcinoma
- What is being tested?
- Sacituzumab Tirumotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 11 sitesBrazil
- Study dates
- Jan 2027to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically confirmed diagnosis of penile squamous cell carcinoma.
- Metastatic or locally advanced disease not amenable to curative intent-therapy (e.g., surgery, radiotherapy, chemoradiotherapy) in the opinion of the investigator.
- Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology (lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions).
- Disease progression on first-line platinum-based chemotherapy for locally advanced/metastatic disease or disease progression within 12 months of (neo) adjuvant chemotherapy completion.
- Male participant at least 18 years of age at the time of providing informed consent.
- Male Participants (Reproductive Potential): If capable of producing sperm, agrees to refrain from donating sperm and use a penile/external condom when having intercourse with a partner of childbearing potential, plus partner use of an additional contraceptive method, during the intervention period and for at least 120 days after the last dose of study intervention.
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- The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
- Life expectancy of at least 12 weeks.
- Provide an archival tumor tissue sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from any site not previously irradiated; formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides (recommended 22-28 slides).
- Recovery from AEs due to previous anticancer therapies to Grade <=1 or baseline (except for alopecia and vitiligo); participants with endocrine-related AEs adequately treated with hormone replacement therapy are eligible.
- Adequate organ function defined by the laboratory values (specimens collected within 14 days before the start of study intervention):
- Absolute Neutrophil Count (ANC) >= 1,500/uL
- Platelets >= 100,000/uL
- Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L
- Measured or calculated Creatinine Clearance > 30 mL/min
- Total Bilirubin <= 1.5 x ULN OR direct bilirubin < ULN for participants with total bilirubin levels > 1.5 x ULN
- AST (SGOT) and ALT (SGPT) <= 2.5 x ULN (<= 5 x ULN for participants with liver metastases)
- Serum Albumin >= 3.0 g/dL
- INR or PT < 1.5 x ULN; aPTT < 1.5 x ULN (unless receiving anticoagulant therapy within therapeutic range)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Willing and able to comply with study procedures, laboratory tests, and other requirements of the study.
- HIV-infected participants are eligible if well-controlled on ART (CD4+ T-cell count >350 cells/mm3, confirmed HIV RNA <50 copies/mL for at least 12 weeks, no AIDS-defining opportunistic infections within past 12 months, and on a stable regimen for at least 4 weeks without strong CYP3A4 inducers/inhibitors).
- Participants with chronic Hepatitis B virus (HBsAg positive) are eligible if received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before enrollment.
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening and completed curative antiviral therapy at least 4 weeks before enrollment.
Who cannot join
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
- Uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months before first dose (NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, or QTcF >480 ms).
- Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
- Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.
- Received prior systemic anticancer therapy within 2 weeks before first dose of study intervention.
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- Received prior radiotherapy within 2 weeks before first dose, has radiation-related toxicities requiring corticosteroids, and/or has had radiation pneumonitis (palliative radiotherapy <= 2 weeks for non-CNS disease completed at least 7 days before first dose is permitted).
- Received a live or live-attenuated vaccine within 30 days before first dose of study intervention.
- Currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued (washout period required is 2 weeks).
- Currently enrolled on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy.
- Received an investigational agent or used an investigational device within 4 weeks before first dose of study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years (except adequately treated basal/squamous cell skin cancer, carcinoma in situ, or low-risk early-stage prostate cancer).
- History of CNS metastases and/or carcinomatous meningitis.
- Active infection requiring systemic therapy within 4 weeks prior to first dose of study treatment (except permitted treated HIV, HBV, HCV).
- Severe hypersensitivity (Grade >=3) to study intervention, any of its excipients, and/or to another biologic therapy.
- Major surgery or significant traumatic injury within 4 weeks before first dose, or anticipation of need for major surgery during treatment.
- History of (noninfectious) pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease.
- Any condition, therapy, laboratory abnormality, or circumstances that might confound study results or interfere with compliance in the opinion of the investigator.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Brazil11 sites
Hospital de Amor de Barretos
Barretos, São Paulo, 14784-400
Pedro Gabriel França Santos, +551733216637, pedro.santos@hospitaldeamor.com.br
Daniel D'Almeida Preto
IEPAM - Instituto de Ensino e Pesquisa da Amazônia
Belém, Pará, 66093-020
Adriana Lameira, +5591981444631, adylameira@gmail.com
Manuel Caitano Dias Ferreira Maia
Hospital Sírio-Libanês DF
Brasília, Federal District, 70200-730
Cristiany de Jesus da Silva de Lima, +5561999932784, cristiany.jslima@hsl.org.br
Fernando Sabino Marques Monteiro
Instituto D'Or de Pesquisa e Ensino Ceará
Fortaleza, Ceará, 60135-237
Monique Maciel Carvalho, +558586865028, monique.macielc@rededor.com.br
Karine Martins da Trindade
ICC - Instituto do Câncer do Ceará
Fortaleza, Ceará, 60430-230
Flavio da Silveria Bitencourt, +5585999547790, flaviosbitencourt@gmail.com
João Paulo Holanda Soares
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
Ana Paula Ferreira Costa, +558440095595, anapaula.costa@liga.org.br
Andrea Juliana Pereira de Santana Gomes
ISCMPA - Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Gustavo Monteiro Escott, +555132148107, gustavo.escott@santacasa.org.br
André Poisl Fay
Futtura Oncologia - Hub de Pesquisa Clínica
Porto Alegre, Rio Grande do Sul, Rio Grande do Sul
Rachel Molina, +55 51 996577731, rachel.molina@futturaoncologia.com
Luísa Rabeno Fasolo
ISEP - Instituto Santa Joana de Ensino e Pesquisa (Rede Américas)
Recife, Pernambuco, 52011-000
Maria Helena Tomaz Ferreira Costa, +5581992994515, mhelenacosta.pc@outlook.com
Andréa Lopes Ponte de Andréa Lopes Ponte de
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)
Salvador, Estado de Bahia, 40050-410
Nivana Borges do Sacramento, +557122038476, nivana.sacramento@santacasaba.org.br
Carolina Alves Costa Silva
BP - A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, 01323-030
Camila de Lollo, +551135056693, camila.lollo@bp.org.br
Rodrigo Coutinho Mariano
About this study
Official title: A Single-arm Phase II Trial of Sacituzumab Tirumotecan (Sac-TMT; MK-2870) as Second-line Treatment for Advanced/Metastatic Penile Squamous Cell Carcinoma: PERSEUS TRIAL (LACOG 1924)
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).
Read the detailed description
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.
- Being tested
- Sacituzumab Tirumotecan
- Keywords
- advanced/metastatic penile squamous cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab TirumotecanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Tirumotecan | Experimental | Participants receive sacituzumab tirumotecan (sac-TMT; MK-2870) at a dose of 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 8 cycles, or until disease progression, unacceptable toxicity, or consent withdrawal, whichever comes first. Receives: Drug: Sacituzumab Tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 cycles (each cycle is 28 days)
Secondary outcomes (9)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 36 months
Overall Survival (OS)
Time from the date of enrollment to the date of death due to any cause.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm, multicenter Phase II trial evaluating sacituzumab tirumotecan (sac-TMT; MK-2870) in participants with advanced/metastatic penile squamous cell carcinoma whose disease progressed on or following platinum-based chemotherapy. All enrolled participants are assigned to receive the single study intervention.
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Fernando Cotait Maluf, Principal investigator, Hospital Beneficência Portuguesa de São Paulo and Hospital Israelita Albert EinsteinKarine Martins da Trindade, Principal investigator, Instituto D'Or de Pesquisa e Ensino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815197
- Sponsor's protocol ID
- LACOG 1924
- Acronym
- PERSEUS
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase II Trial of Sacituzumab Tirumotecan (Sac-TMT; MK-2870) as Second-line Treatment for Advanced/Metastatic Penile Squamous Cell Carcinoma: PERSEUS TRIAL (LACOG 1924)
- ClinicalTrials.gov ID
- NCT07815197
- Acronym / sponsor ID
- PERSEUS / LACOG 1924
- Keywords
- advanced/metastatic penile squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm, multicenter Phase II trial evaluating sacituzumab tirumotecan (sac-TMT; MK-2870) in participants with advanced/metastatic penile squamous cell carcinoma whose disease progressed on or following platinum-based chemotherapy. All enrolled participants are assigned to receive the single study intervention.
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Tirumotecan | Experimental | Drug: Sacituzumab TirumotecanParticipants receive sacituzumab tirumotecan (sac-TMT; MK-2870) at a dose of 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 8 cycles, or until disease progression, unacceptable toxicity, or consent withdrawal, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically- or cytologically confirmed diagnosis of penile squamous cell carcinoma.
- Metastatic or locally advanced disease not amenable to curative intent-therapy (e.g., surgery, radiotherapy, chemoradiotherapy) in the opinion of the investigator.
- Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology (lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions).
- Disease progression on first-line platinum-based chemotherapy for locally advanced/metastatic disease or disease progression within 12 months of (neo) adjuvant chemotherapy completion.
- Male participant at least 18 years of age at the time of providing informed consent.
Key exclusion criteria (18 listed)
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
- Uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months before first dose (NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, or QTcF >480 ms).
- Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
- Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab TirumotecanSacituzumab 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. | Drug | Sacituzumab Tirumotecan |
Primary outcome
Objective Response Rate (ORR) by Investigator Assessment
Time frame: Up to 8 cycles (each cycle is 28 days)
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.
9 secondary outcomes
Objective Response Rate by Independent Central Review (ORR-ICR)
Time frame: Up to 8 cycles (each cycle is 28 days)
Disease Control Rate (DCR)
Time frame: Up to 8 cycles (each cycle is 28 days)
Clinical Benefit Rate (CBR)
Time frame: At 24 weeks
Duration of Response (DoR)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Incidence and Severity of Adverse Events (Safety and Toxicity)
Time frame: From baseline up to 30 days after the last dose of study intervention.
Treatment Compliance
Time frame: Up to 8 cycles (each cycle is 28 days)
Post-Progression Therapies
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando Cotait Maluf principal investigator
Hospital Beneficência Portuguesa de São Paulo and Hospital Israelita Albert Einstein
Karine Martins da Trindade principal investigator
Instituto D'Or de Pesquisa e Ensino
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan in people with Penile Squamous Cell Carcinoma and Metastatic Penile Squamous Cell Carcinoma, run by Latin American Cooperative Oncology Group at 11 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+55 (51) 3384.5334, lacog1924@lacog.group), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by Investigator Assessment (time frame: Up to 8 cycles (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.