A Phase 1 Study of KK2269 Monotherapy and Combination Therapy with Docetaxel in Adult Participants with Solid Tumors

JRCT ID: jRCT2031230419

Registered date:21/10/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

-Part 1: locally advanced or metastatic solid tumors
-Part 2: gastric/GEJ/ESO(adeno) or NSCLC

• Date of first enrollment: 25/01/2024
• Target sample size: 71
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

<Part 1>
KK2269 will be administered at each dose level, intravenous infusion.

<Part 2>
KK2269 will be administered at each dose level intravenously in combination with docetaxel.
Docetaxel will be administered intravenously (Q3W).

Outcome(s)

Primary Outcome

<Part 1>
- DLTs
- AEs
- Laboratory test values
- Vital signs
- ECG parameters

<Part 2>
- DLTs (dose-escalation part)
- AEs
- Laboratory test values
- Vital signs
- ECG parameters

Key inclusion & exclusion criteria

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

Include criteria

<Key Common Inclusion Criteria for Part 1 and Part 2>
-Patients who are >= 18 years old at the time of informed consent
-Patients who have disease measurable by RECIST v1.1
-Patients with an ECOG PS of 0 or 1
-Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator
-The specified periods have passed respectively after the completion of the cancer treatments as of the date of enrollment
-Patients who agree to use a medically effective method of contraception

<Key Additional Inclusion Criteria for Part 1>
-Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor

<Key Additional Inclusion Criteria for All Participants in Part 2>
-Patients with histological or cytological evidence of any of the following disease
- Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma
- NSCLC
-Patients who are suitable for docetaxel treatment

Exclude criteria

<Key Common Exclusion Criteria for Part 1 and Part 2>
-Patients with an uncontrolled or serious intercurrent illness
-Patients with known active central nervous system metastasis
-Patients with a history of >= Grade 3 allergic reaction to any antibody drug
-Patients with a history of autoimmune disease
-Patients with a history of HIV, HBV, or HCV at screening
-Patients who have a history of primary immunodeficiency

<Key Additional Exclusion Criterion for Part 2>
-Patients with a history of treatment with docetaxel

Related Information

• Primary Sponsor: Enokitani Kouki