A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors

Launched by KYOWA KIRIN CO., LTD. · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KK2260 for patients with advanced or metastatic solid tumors, which are cancers that have spread from where they started. The trial has two parts: the first part focuses on finding the highest dose of KK2260 that patients can tolerate while checking how safe it is. The second part compares the safety of different doses of KK2260 in patients with various types of cancer.

To participate, you need to be at least 18 years old, have cancer that hasn’t responded to standard treatments, or for which no standard treatment exists. You should also be able to provide a tumor sample for testing and meet certain health criteria. If you decide to join, you’ll receive KK2260 and will be monitored closely for any side effects. It’s important to know that this is an early-stage study, meaning researchers are still learning how well this treatment works and how safe it is for people with cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \<Common Inclusion Criteria for Part 1a, Part 1b, and Part 2
• • 1. Patients who have given informed written consent.
• • 2. Male or female subjects ≥18 years of age, at time of signing informed consent.
• • 3. Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment.
• • 4. Patients with measurable disease according to RECIST version 1.1
• • 5. Patients who have had the certaion periods between the date of completion of prior therapy and the date of enrollment
• • 6. Subjects who agree to have a tumor biopsy as part of the baseline examination. Patients who have difficulty in performing a tumour biopsy and have agreed to submit a previously collected stored specimen.
• • 7. Patients with an ECOG PS of 0 or 1 at baseline.
• • 8. Patients with haematopoietic, hepatic, renal, cardiac and respiratory functions that meet certain criteria in a baseline test.
• • \<Additional Inclusion Criteria for Part 1a
• • 1) Patients with pathologically diagnosed advanced or metastatic solid tumors.
• • \<Additional Inclusion Criteria for Part 1b
• • 1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer, or advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses.
• • 2. Patients with pathologically diagnosed squamous cell carcinoma.
• • 3. Patients who agree to undergo tumor biopsy after administration.
• • \<Additional Inclusion Criteria for Part 2a
• • 1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer.
• • 2. Patients with pathologically diagnosed squamous cell carcinoma.
• • 3. Patients who agree to undergo tumor biopsy after administration.
• • \<Additional Inclusion Criteria for Part 2b
• • 1. Patients with advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses.
• • 2. Patients with pathologically diagnosed squamous cell carcinoma.
• • 3. Patients who agree to undergo tumor biopsy after administration.
• Exclusion Criteria:
• • \<Common Exclusion Criteria to Part 1 and Part 2\>
• • 1. Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.
• • 2. Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.
• • 3. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.
• • 4. Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.
• • 5. Patients who have not recovered to Grade 1 or below from adverse events caused by previously administered anticancer therapy.
• • 6. Patients with active interstitial lung disease or a history of active interstitial lung disease.
• • 7. Patients with infectious diseases requiring systemic treatment.
• • 8. Patients with a fever of 38.0°C or higher at the time of registration.
• • 9. Patients who test positive for Hepatitis B virus antigen or antibody, Hepatitis C virus antibody, or HIV antibody in a baseline test.