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

Official title

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

Overview

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.

Interventions

• Drug KK2260
  KK2260 will be administered intravenously at several dose levels, and after determining MTD, multiple dose regimens will be evaluated in multiple cancer types to target.
• Drug KK2260
  KK2260 will be administered intravenously at several dose levels, and after determining MTD, multiple dose regimens will be evaluated in multiple cancer types to target.

Primary outcome measures

• Dose-limiting toxicity (Only in Part 1a) [Time frame: During the first cycle (1 Cycle = 28 days)]
• Adverse Events [Time frame: Through study completion, an average of 1 year]
• Changes in Laboratory Testing Values (Red blood cell count) [Time frame: Every week through study completion, an average of 1 year]
• Changes in Laboratory Testing Values (Hemoglobin concentration) [Time frame: Every week through study completion, an average of 1 year]
• Changes in Laboratory Testing Values (Hematocrit) [Time frame: Every week through study completion, an average of 1 year]
• Changes in Laboratory Testing Values (Reticulocyte) [Time frame: Every week through study completion, an average of 1 year]
• Changes in Laboratory Testing Values (Mean corpuscular volume) [Time frame: Every week through study completion, an average of 1 year]
• Changes in Laboratory Testing Values (Mean corpuscular hemoglobin) [Time frame: Every week through study completion, an average of 1 year]
• Changes in Laboratory Testing Values (Mean corpuscular hemoglobin concentration) [Time frame: Every week through study completion, an average of 1 year]
• Changes in Laboratory Testing Values (White blood cell count) [Time frame: Every week through study completion, an average of 1 year]

Secondary outcome measures (10)

• Serum concentration levels of KK2260 [Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)]
• Maximum Plasma Concentration (Cmax) [Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)]
• Area Under the blood concentration-time Curve (AUC) [Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)]
• Anti-drug antibody [Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)]
• Overall Response Rate (in Part 1b/2) [Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)]
• Disease Control Rate (in Part 1b/2) [Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)]
• Duration of Response (in Part 1b/2) [Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)]
• Progression-Free Survival (in Part 1b/2) [Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)]
• Overall Survival (in Part 1b/2) [Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)]
• Time to Response (in Part 1b/2) [Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)]

Eligibility criteria

Inclusion criteria

<Common Inclusion Criteria for Part 1a, Part 1b, and Part 2

• Patients who have given informed written consent.
• Male or female subjects ≥18 years of age, at time of signing informed consent.
• Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment.
• Patients with measurable disease according to RECIST version 1.1
• Patients who have had the certaion periods between the date of completion of prior therapy and the date of enrollment
• 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.
• Patients with an ECOG PS of 0 or 1 at baseline.
• 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

• 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.
• Patients with pathologically diagnosed squamous cell carcinoma.
• Patients who agree to undergo tumor biopsy after administration.

<Additional Inclusion Criteria for Part 2a

• Patients with pathologically diagnosed with advanced or metastatic esophageal cancer.
• Patients with pathologically diagnosed squamous cell carcinoma.
• Patients who agree to undergo tumor biopsy after administration.

<Additional Inclusion Criteria for Part 2b

• 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.
• Patients with pathologically diagnosed squamous cell carcinoma.
• Patients who agree to undergo tumor biopsy after administration.

Exclusion criteria

<Common Exclusion Criteria to Part 1 and Part 2>

• Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.
• Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.
• Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.
• Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.
• Patients who have not recovered to Grade 1 or below from adverse events caused by previously administered anticancer therapy.
• Patients with active interstitial lung disease or a history of active interstitial lung disease.
• Patients with infectious diseases requiring systemic treatment.
• Patients with a fever of 38.0°C or higher at the time of registration.
• Patients who test positive for Hepatitis B virus antigen or antibody, Hepatitis C virus antibody, or HIV antibody in a baseline test.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Japan · 14 centers

• Aichi Cancer Center Hospital — Nagoya
• National Cancer Center Hospital East — Kashiwa
• Shikoku Cancer Center — Matsuyama
• Hiroshima University Hospital — Hiroshima
• Kobe University Hospital — Kobe
• Kanagawa Cancer Center — Yokohama
• Kumamoto University Hospital — Kumamoto
• Tohoku University Hospital — Sendai
• … and 6 more centers

Identifiers

NCT: NCT06248411 · 2260-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗