A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
NCT06248411 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 189
Last updated 2026-03-18
Summary
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.
Conditions
- Advanced or Metastatic Solid Tumors
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.
Sponsors & Collaborators
-
Kyowa Kirin Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-01
- Primary Completion
- 2029-10-31
- Completion
- 2030-04-30
Countries
- Japan
Study Locations
More Related Trials
-
KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT02867007 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)
NCT04152499 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
NCT02503423 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
NCT06026410 ·Status: RECRUITING ·Phase: PHASE1
-
A Phase 1 Study of NM6603 in Advanced Solid Tumors
NCT06046066 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114
NCT05200273 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors
NCT02223247 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors
NCT06403436 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors
NCT06644755 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of KC1086 in Patients With Advanced Solid Tumors
NCT07118709 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors
NCT05244551 ·Status: RECRUITING ·Phase: PHASE1
-
A Phase 1 Study Evaluating the Safety of TRK-950 in Patients With Advanced Solid Tumors
NCT02990481 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications
NCT02649790 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
NCT04192344 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)
NCT01071018 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT03071757 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Injection HB0025 in Patients With Advanced Solid Tumors
NCT04678908 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study of HS-20122 in Patients With Advanced Solid Tumors
NCT06927570 ·Status: RECRUITING ·Phase: PHASE1
-
First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors
NCT04417465 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors
NCT01447732 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid Tumors
NCT04242147 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of KC1036 in Patients with Advanced Solid Tumors
NCT04387916 ·Status: RECRUITING ·Phase: PHASE1
-
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
NCT05514444 ·Status: COMPLETED ·Phase: PHASE1
-
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
NCT01881217 ·Status: COMPLETED ·Phase: PHASE1
-
L-778,123 in Treating Patients With Recurrent or Refractory Solid Tumors
NCT00003430 ·Status: COMPLETED ·Phase: PHASE1