NCT07384416

Single-Arm Trial of QL1706, Lenvatinib, and Nab-Paclitaxel for Advanced Refractory Penile Cancer

QL1706 Combined With Lenvatinib and Nab-Paclitaxel in the Treatment of Recurrent or Refractory Advanced Penile Cancer: a Single Arm, Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to evaluate the combination of QL1706, Lenvatinib, and Nab-Paclitaxel for the treatment of recurrent or refractory advanced penile cancer and to assess the safety of this regimen. The main questions it aims to answer are: * Can the combination of QL1706, Lenvatinib, and Nab-Paclitaxel shrink tumors or prolong the time to disease progression in participants with advanced penile cancer? * What side effects do participants experience while taking this three-drug combination? Researchers will compare the tumor response in participants receiving this treatment with historical data from standard therapies to determine whether the new combination is more effective for this type of cancer. This is a single-arm study, meaning all participants will receive the same investigational combination. Participants will: * Receive intravenous infusions of QL1706 and Nab-Paclitaxel every 21 days, along with daily oral Lenvatinib capsules. * Continue treatment cycles until disease progression, unacceptable side effects occur, or they choose to withdraw from the study. * Attend regular clinic visits for imaging scans (such as CT scans), physical examinations, and blood tests to monitor treatment response and safety. * Have their tumors measured by scans at scheduled intervals to evaluate treatment efficacy.

Conditions

• Penile Cancer

Interventions

Type	Name	Description
DRUG	QL1706 + Lenvatinib + Nab-Paclitaxel	Lenvatinib: 8 mg once daily (for body weight \<60 kg) or 12 mg once daily (for body weight ≥60 kg). QL1706: 5 mg/kg, administered by intravenous infusion (iv) on Day 1 of each cycle. Nab-Paclitaxel: 260 mg/m², administered by intravenous infusion (iv) on Day 1 of each cycle. Treatment Cycle: Each cycle is 21 days. The combination therapy will be administered for 4 cycles. Maintenance Therapy: QL1706 treatment will continue for up to 1 year. Lenvatinib will be taken orally until disease progression.

Timeline

• Start date: 2026-02-10
• Primary completion: 2029-02-01
• Completion: 2031-01-31
• First posted: 2026-02-03
• Last updated: 2026-02-04