Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04152499
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2019-10-29
Brief Title:
Phase I-II FIH TROP2 ADC Advanced UnresectableMetastatic Solid Tumors Refractory to Standard Therapies
Sponsor:
Klus Pharma Inc
Organization:
Klus Pharma Inc
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
A264
Brief Summary:
A Phase I-II First-in-Human Study of SKB264 in Patients with Locally Advanced UnresectableMetastatic Solid Tumors who are refractory to Available Standard Therapies Patient must have historically documented incurable locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types
1 Triple negative breast cancer
2 Epithelial ovarian cancer
3 Non-small cell lung cancer
4 Gastric adenocarcinomaGastroesophageal junction adenocarcinoma
5 Small cell lung cancer
6 HR HER2-breast cancer
7 Head and neck squamous cell carcinoma
8 Endometrial carcinoma
9 Urothelial carcinoma
1 Triple negative breast cancer
2 Epithelial ovarian cancer
3 Non-small cell lung cancer
4 Gastric adenocarcinomaGastroesophageal junction adenocarcinoma
5 Small cell lung cancer
6 HR HER2-breast cancer
7 Head and neck squamous cell carcinoma
8 Endometrial carcinoma
9 Urothelial carcinoma
Detailed Description:
This is an open label Phase I-II first in human FIH study for SKB264 as monotherapy in patients who have locally advanced unresectable or metastatic solid tumor that is refractory to all standard therapies TROP2 trophoblast antigen 2 assessments will not be performed prior to enrollment but it will be assessed retrospectively Confirmation of TROP2 trophoblast antigen 2 expression by immunohistology or other means is not required but the Sponsor will request fresh tumor biopsy or tissue specimens from archived materials for determination of TROP2 trophoblast antigen 2 expression retrospectively The patient must be in the judgment of the investigator an appropriate candidate for experimental therapy whose tumor is refractory to standard therapies Patients will receive study drug as a single IV infusion at the prescribed dose level at each administration Cycles will continue until disease progression or unacceptable toxicity The study is divided into 2 parts Phase I and Phase II
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None