NCT06248411 A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
| NCT ID | NCT06248411 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kyowa Kirin Co., Ltd. |
| Condition | Advanced or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 189 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2029-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 189 participants in total. It began in 2023-11-01 with a primary completion date of 2029-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer type). In Part 1b and Part 2, at least two dosing regimens and two dosing regimens by cancer type, respectively, will be selected, and the safety, tolerability, and efficacy of each regimen will be evaluated.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06248411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06248411 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06248411 currently recruiting?
Yes, NCT06248411 is actively recruiting participants. Contact the research team at clinical.info.jp@kyowakirin.com for enrollment information.
Where is the NCT06248411 trial being conducted?
This trial is being conducted at Nagoya, Japan, Kashiwa, Japan, Matsuyama, Japan, Hiroshima, Japan and 10 additional locations.
Who is sponsoring the NCT06248411 clinical trial?
NCT06248411 is sponsored by Kyowa Kirin Co., Ltd.. The trial plans to enroll 189 participants.