Clear cell papillary renal cell carcinoma Trials in Disease

Study Comparing Savolitinib and Durvalumab with Sunitinib and Durvalumab for Patients with Advanced Papillary Renal Cell Carcinoma

This trial is designed for patients with papillary renal cell carcinoma that has spread or cannot be removed by surgery. The study specifically focuses on cancer that is driven by changes in a gene called MET.

Main inclusion criteria:

• Confirmed diagnosis of papillary renal cell carcinoma that cannot be surgically removed and has spread locally or to other parts of the body
• The cancer must be confirmed as MET-driven through specialized laboratory testing
• No previous treatment for cancer that has spread
• Karnofsky Score of 70 or higher, indicating reasonable ability to perform daily activities
• At least one measurable area of cancer that has not been treated with radiation
• Adequate organ and bone marrow function
• Life expectancy of at least 12 weeks
• Tumor sample must be provided for analysis

Main exclusion criteria:

• Other types of cancer unrelated to the study
• Previous treatment with the same or similar medications being tested
• Severe or uncontrolled medical conditions
• Pregnancy or breastfeeding
• Known allergies to the study medications
• Certain heart conditions
• Active infections requiring treatment
• Recent participation in another clinical trial

Focus and goal: The trial compares the effectiveness of three different treatment approaches: savolitinib combined with durvalumab, sunitinib alone, or durvalumab alone. The main goal is to determine how long patients live without their cancer getting worse (progression-free survival). The study will also measure overall survival, response rates, and duration of response.

Investigational drugs:

• Savolitinib - A targeted therapy taken as tablets that blocks the MET receptor, a protein that helps cancer cells grow when overactive
• Durvalumab - An immunotherapy given as an infusion that helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein
• Sunitinib - An approved treatment given as capsules that blocks multiple proteins needed for cancer cell growth and blood vessel formation

Study of JK06 for Patients with Advanced or Metastatic Cancer

This trial is studying a new medication called JK06 for patients with various types of advanced cancer that cannot be surgically removed, including renal cell carcinoma among other cancer types.

Main inclusion criteria:

• At least 18 years old
• Willing to provide a fresh tumor biopsy before treatment
• Cancer that cannot be removed by surgery and has spread or is advanced
• Must have tried standard treatments or be unable to receive them
• Performance status of 0 or 1 (fully active or able to carry out light work)
• Life expectancy of at least 12 weeks
• Measurable disease on imaging tests
• Adequate laboratory test results for blood counts and organ function
• Willing to use effective contraception if applicable

Main exclusion criteria:

• Recent cancer treatment
• Pregnancy or breastfeeding
• Allergies to the study medication
• Unable to follow study procedures or attend visits
• Participating in another clinical trial simultaneously
• Certain heart conditions
• Uncontrolled infections or serious illnesses
• Recent or planned surgery during the study period

Focus and goal: This is a Phase 1/2 trial focused on determining the safety, tolerability, and optimal dose of JK06. The study has two phases: the first gradually increases the dose to find the right amount, and the second phase tests the selected dose in more patients. Treatment is given every three weeks through an intravenous infusion.

Investigational drug:

• JK06 - An antibody-drug conjugate that combines an antibody targeting the 5T4 protein on cancer cells with a drug that kills those cells. This approach aims to deliver treatment directly to cancer cells while minimizing damage to normal cells

Study of JK08, Pembrolizumab, and Lenvatinib for Patients with Advanced or Metastatic Cancer

This study is testing JK08, a new experimental treatment, either alone or in combination with pembrolizumab (Keytruda) and lenvatinib (Lenvima) for patients with various types of advanced cancer, including renal cell carcinoma.

Main inclusion criteria:

• At least 18 years old
• Willing to have tumor biopsies before and during treatment (with some exceptions)
• Cancer that cannot be removed by surgery or has spread
• Must have tried standard treatments without success or cannot receive them
• Performance status of 0 or 1 (fully active or able to carry out light work)
• Life expectancy of at least 12 weeks
• Measurable disease on CT or MRI scans
• Acceptable laboratory test results
• Effective contraception use if applicable
• Previous tumor sample must be provided

Main exclusion criteria: The exclusion criteria are similar to other trials and include pregnancy, breastfeeding, certain health conditions, inability to follow study procedures, recent participation in other trials, known allergies, heart conditions, uncontrolled infections, and recent or planned surgery.

Focus and goal: This Phase 1/2 trial aims to determine the safety, tolerability, and optimal dose of JK08. The study will test JK08 alone and in combination with other medications. JK08 is given as a weekly injection under the skin, while pembrolizumab is given as an infusion and lenvatinib as oral capsules, depending on the specific treatment combination.

Investigational drugs:

• JK08 - An IL-15 antibody fusion protein that targets CTLA-4, designed to stimulate the immune system to fight cancer cells
• Pembrolizumab (Keytruda) - An established immunotherapy that may be used in combination with JK08
• Lenvatinib (Lenvima) - A receptor tyrosine kinase inhibitor that blocks proteins promoting cancer cell growth, may be used in combination therapy

Summary

Currently, three clinical trials are actively recruiting patients with clear cell papillary renal cell carcinoma or related advanced kidney cancers. These studies are concentrated primarily in European countries, with Spain and Belgium offering the most trial options, hosting all three studies, while other countries participate in specific trials.

The trials represent different therapeutic approaches. The first study focuses specifically on MET-driven papillary renal cell carcinoma, comparing targeted therapy with immunotherapy combinations. The other two trials are broader studies that include renal cell carcinoma among multiple cancer types, testing novel antibody-based treatments (JK06 and JK08) that are in early-phase investigation.

All three trials require patients to have advanced or metastatic cancer that cannot be surgically removed, adequate organ function, and reasonable overall health status. The studies involve regular monitoring, imaging tests, and some require tumor biopsies. Patients interested in participating should discuss these options with their healthcare team to determine eligibility and suitability for their specific situation.