Clinical Research Directory

Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy

This is a single-center, single-arm, open-label, Phase 2 clinical trial (the SCOPE study) evaluating the efficacy, safety, and tolerability of sacituzumab tirumotecan (SKB264) combined with toripalimab as a second-line, chemo-free treatment for patients with unresectable locally advanced or metastatic penile squamous cell carcinoma whose disease progressed on or who are intolerant to platinum-based chemotherapy. Penile squamous cell carcinoma (PSCC) is a rare and aggressive cancer with limited treatment options once disease progression occurs after initial platinum-based chemotherapy, and standard second-line approaches leave tumors shrinking or disappearing in only 10-15% of cases. Sacituzumab tirumotecan is an antibody-drug conjugate (ADC) designed to target TROP-2, a protein expressed on the surface of nearly all penile cancer cells. By binding to TROP-2, sacituzumab tirumotecan delivers a chemotherapy payload directly to the tumor cells. Toripalimab is an immunotherapy drug (a PD-1 inhibitor) that helps the body's immune system find and attack cancer cells, and combining an ADC with a PD-1 inhibitor may work better than either drug alone. All participants in this trial will receive both study drugs via intravenous (IV) infusion on Day 1 of each 2-week cycle, toripalimab first, followed by sacituzumab tirumotecan about 30 minutes later, for as long as the treatment is helping them and the side effects are tolerable. The main goal of this study is to determine the percentage of participants whose tumors shrink or disappear after receiving the combination (Objective Response Rate). The study will also measure how long the responses last (Duration of Response), how long participants live without their cancer getting worse (Progression-Free Survival), how long participants live overall (Overall Survival), the percentage of participants whose disease is controlled (Disease Control Rate), and the side effects of the combination.

DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma

The DEPECA-1 trial is the first systematic Phase II trial to evaluate response and survival to a combination of antibody-drug conjugate enfortumab vedotin plus the PD-L1 inhibitor avelumab in patients with locally advanced and metastatic penile squamous cell carcinoma (PeCa) in the 1st line setting.

Neoadjuvant Pucotenlimab and Becotatug Vedotin for Locally Advanced Penile Cancer

This is an open-label, multicenter, single-arm Phase 2 clinical trial evaluating neoadjuvant pucotenlimab (anti-PD-1 immunotherapy) combined with becotatug vedotin (EGFR-targeted antibody-drug conjugate, ADC) for adults with locally advanced penile squamous cell carcinoma. Eligible patients have high-risk disease defined as T4 primary tumor with any nodal status or any T stage with N2-N3 lymph node metastasis and no distant metastasis. All participants receive up to 4 cycles of combination neoadjuvant therapy every 3 weeks. After treatment completion, a multidisciplinary team will assess if consolidative surgery can be performed. Patients who undergo surgery will continue single-agent pucotenlimab adjuvant treatment for 17 additional cycles (approximately 1 year). The primary goal is to measure the pathological complete response (pCR) rate. Secondary goals include objective response rate (ORR), progression-free survival (PFS),overall survival (OS) and safty profiles. Blood and tumor tissue samples will be collected to explore biomarkers that may predict treatment response and drug resistance. A total of 29 male patients will be enrolled.