A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable /Metastatic Solid Tumors Who are Refractory to Available Standard Therapies

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508700-38-00

Acronym

KL264-01

Enrollment

Registered

2024-06-17

Start date

Unknown

Completion date

2024-12-10

Last updated

2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic or locally advanced unresectable solid tumors progressing after available standard therapies

Brief summary

ORR (the percentage of patients who achieve CR/PR) per RECIST 1.1

Detailed description

Percentage of patients with adverse events, serious adverse events DOR.PFS (time frame: baseline to the end of the study).OS (time frame: baseline to the end of the study).Immunogenicity of SKB264.PK parameters for SKB264-ADC, SKB264-TAB, and free KL610023 payload.Levels of TROP2 expression in tumor tissue and correlation of those levels with responses.

Interventions

DRUG-

DRUGCIMETIDINE

DRUGROXATIDINE

DRUGFAMOTIDINE

DRUGCOMBINATIONS

DRUGPARACETAMOL

DRUGRANITIDINE

DRUGNIZATIDINE

DRUGSKB264

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR (the percentage of patients who achieve CR/PR) per RECIST 1.1	—

Secondary

Measure	Time frame
Percentage of patients with adverse events, serious adverse events DOR.PFS (time frame: baseline to the end of the study).OS (time frame: baseline to the end of the study).Immunogenicity of SKB264.PK parameters for SKB264-ADC, SKB264-TAB, and free KL610023 payload.Levels of TROP2 expression in tumor tissue and correlation of those levels with responses.	—

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026