Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171750
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-11-29
Brief Title:
Phase I Study of ANK-101 in Advanced Solid Tumors
Sponsor:
Ankyra Therapeutics Inc
Organization:
Ankyra Therapeutics Inc
Study Overview
Official Title:
A Phase I Open-Label Dose Escalation Study of the Safety and Tolerability of ANK-101 in Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
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:
ANCHOR
Brief Summary:
This is a Phase 1 multicenter open-label dose escalation study to determine the safety and tolerability of intratumoral IT injection of ANK-101 in participants with advanced solid tumors who have progressed during or after receiving standard of care SOC therapy or who will not benefit from such therapy The study will be conducted in two parts Part 1 will enroll participants with superficial lesions and Part 2 will enroll participants with visceral lesions
Detailed Description:
This Phase 1 first-in-human FIH study will 1 evaluate the safety tolerability pharmacokinetic and pharmacodynamic effects and preliminary clinical activity of ANK-101 administered as an intratumoral IT injection in participants with superficial or visceral lesions and 2 determine the recommended dose for expansion RDE of ANK-101
For both parts the study design consists of six sequential dose-escalation cohorts and an expansion cohort at the RDE Part 1 will enroll participants with advanced solid tumors with cutaneous subcutaneous or nodal disease accessible by clinical palpation or ultrasound guidance Part 2 will start once the DLT period of dose level 1 in Part 1 is completed and dose level 2 is opened Part 2 will enroll participants with visceral disease accessible by interventional radiology or endoscopic techniques Participants in Part 2 may also have superficial lesions that can be injected if in the Investigators opinion this is clinically indicated
Ten participants will be dosed in a Part 1 dose expansion cohort at the RDE and in Part 2 the dose expansion cohort at the RDE will include 10 participants with non-small cell lung cancer NSCLC
For both parts the study design consists of six sequential dose-escalation cohorts and an expansion cohort at the RDE Part 1 will enroll participants with advanced solid tumors with cutaneous subcutaneous or nodal disease accessible by clinical palpation or ultrasound guidance Part 2 will start once the DLT period of dose level 1 in Part 1 is completed and dose level 2 is opened Part 2 will enroll participants with visceral disease accessible by interventional radiology or endoscopic techniques Participants in Part 2 may also have superficial lesions that can be injected if in the Investigators opinion this is clinically indicated
Ten participants will be dosed in a Part 1 dose expansion cohort at the RDE and in Part 2 the dose expansion cohort at the RDE will include 10 participants with non-small cell lung cancer NSCLC
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