A Phase I clinical study of KK2260 in patients with advanced or metastatic solid tumors

JRCT ID: jRCT2031230372

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced or metastatic solid tumors, esophageal cancer, head and neck squamous cell carcinoma
• Date of first enrollment: 01/11/2023
• Target sample size: 139
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

<Part 1>
KK2260 will be administered at each dose level, intravenous infusion

<Part 2>
Multiple dose regimens of KK2260, not to exceed the MTD determined based on the results of Part 1, will be administered intravenous infusion.

Outcome(s)

Primary Outcome

<Part 1>
- Dose-limiting toxicity
- Adverse Events
- Laboratory Test Values
- Vital signs
- Electrocardiogram
- ECOG PS

<Part 2>
- Adverse events
- Laboratory values
- Vital signs
- Electrocardiogram
- ECOG PS

Secondary Outcome

<Part 1>
- Serum concentration levels of KK2260
- Pharmacokinetic
- Anti-drug antibody

<Part 2>
- Efficacy
- Serum Concentration levels of KK2260
- pharmacokinetic
- Anti-drug antibody

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

<Common Inclusion Criteria to Part 1 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 1>
1) Patients with pathologically diagnosed advanced or metastatic solid tumors.

<Additional Inclusion Criteria for Part 2a>
1) Patients with pathologically diagnosed with advanced or metastatic esophageal cancer.

<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.

Exclude criteria

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 degrees or higher at the time of registration.
9) Patients who test positive for HBV antigen or antibody, HCV antibody, or HIV antibody in a baseline test.

Related Information

• Primary Sponsor: Takase Riho