Phase I Study of ANK-101 in Advanced Solid Tumors — ANCHOR  

Solid Tumor Clinical Trial

Official title: A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of ANK-101 in Advanced Solid Tumors

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Investigator's 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). ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Cutaneous Tumor
• Malignant Solid Tumor
• Metastatic Solid Tumor
• Neoplasms
• Non Small Cell Lung Cancer
• Skin Neoplasms
• Solid Tumor

• NCT number: NCT06171750
• Study type: Interventional
• Source: Ankyra Therapeutics, Inc
• Contact: Gail Iodice, BSN, RN
• Phone: 347-882-1147
• Email: giodice@ankyratx.com
• Status: Recruiting
• Phase: Phase 1
• Start date: January 19, 2024
• Completion date: January 2026