Health TrialsbyHealthPanel

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

ConditionAdvanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKyowa Kirin Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • KK2260

    Drug

    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.

  • KK2260

    Drug

    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.

Treatment groups

189 Participants
are divided into 2 treatment groups
Group A: KK2260 (Dosing regimen 1)Experimental treatment 1 intervention
Group B: KK2260 (Dosing regimen 2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (Only in Part 1a)

Time frame
During the first cycle (1 Cycle = 28 days)
2

Adverse Events

Time frame
Through study completion, an average of 1 year
3

Changes in Laboratory Testing Values (Red blood cell count)

Time frame
Every week through study completion, an average of 1 year
4

Changes in Laboratory Testing Values (Hemoglobin concentration)

Time frame
Every week through study completion, an average of 1 year

Secondary outcomes

1

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)
2

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)
3

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)
4

Anti-drug antibody

Time frame
Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyowa Kirin Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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