Testing KK2260 in patients with advanced or metastatic solid tumors

A Phase 1, Uncontrolled, Open-label, Non-randomized, Dose-escalation Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors, Followed by an Uncontrolled, Non-randomized Study and an Uncontrolled, Randomized Study in Patients With Esophageal Squamous Cell Carcinoma or Head and Neck Squamous Cell Carcinoma

This study is testing a new drug called KK2260 to see if it is safe and effective for people with advanced or metastatic solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 189 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kyowa Kirin Co., Ltd. (Industry-sponsored)
• Locations: 13 sites (Nagoya, Aichi-ken and 12 other locations)
• Trial ID: NCT06248411 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors. The study is divided into two parts: Part 1a focuses on determining the maximum tolerated dose (MTD) of KK2260, while Parts 1b and 2 will assess various dosing regimens and their efficacy based on cancer type. Patients will be monitored for safety and treatment response throughout the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors who are refractory to or intolerant of standard treatments.

Not a fit: Patients with early-stage tumors or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced or metastatic solid tumors who have limited alternatives.

How similar studies have performed: Other studies involving novel treatments for advanced solid tumors have shown promise, but the specific approach with KK2260 is novel.

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.

Where this trial is running

Nagoya, Aichi-ken and 12 other locations

• Aichi Cancer Center Hospital — Nagoya, Aichi-ken, Japan (Recruiting)
• National Cancer Center Hospital East — Kashiwa, Chiba, Japan (Recruiting)
• Hiroshima University Hospital — Hiroshima, Hiroshima, Japan (Not_yet_recruiting)
• Kobe University Hospital — Kobe, Hyōgo, Japan (Recruiting)
• Kanagawa Cancer Center — Yokohama, Kanagawa, Japan (Recruiting)
• Kumamoto University Hospital — Kumamoto, Kumamoto, Japan (Not_yet_recruiting)
• Tohoku University Hospital — Sendai, Miyagi, Japan (Not_yet_recruiting)
• Saitama Cancer Center — Shinden, Saitama, Japan (Recruiting)
• Shizuoka Cancer Center — Nagaizumi-cho, Shizuoka, Japan (Recruiting)
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (Recruiting)
• The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (Recruiting)
• Kyushu Cancer Center — Fukuoka, Japan (Recruiting)
• Osaka International Cancer Institute — Osaka, Japan (Recruiting)

Study contacts

• Study coordinator: Kyowa Kirin Co., Ltd.

Conditions Advanced or Metastatic Solid Tumors