Sacituzumab Tirumotecan as Second-Line Treatment for Penile Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorLatin American Cooperative Oncology Group
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab Tirumotecan
DrugSacituzumab 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.
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: Sacituzumab TirumotecanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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 weeks4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Latin American Cooperative Oncology Group
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov
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