A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors

NCT ID: NCT06656390

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2028-04-22

Brief Summary

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.

Conditions

Advanced Cancer; Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Dose-escalation Phase, Part B: Dose-expansion Phase

A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B).

A dose-expansion study which will enroll the select indications.

Group Type: EXPERIMENTAL

ALK201

Intervention Type: DRUG

Administered intravenously, once every 3 weeks

Interventions

ALK201

Administered intravenously, once every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women ≥18 and ≤75 years old on the day of signing the ICF
• At least 1 measurable lesion per RECIST v1.1
• Expected survival ≥3 months
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
• Adequate organ function
• Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms

Exclusion Criteria

• Active or pre-existing autoimmune diseases that may relapse
• Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage
• Allergies to any component of ALK201 or other monoclonal antibodies
• Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
• Combined with ≥ Grade 2 stomatitis and/or nose bleeding at screening
• Vaccinated with live vaccines within 4 weeks prior to the first dose

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Allink Biotherapeutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Care Wollongong

Wollongong, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

ALK Tang

Role: CONTACT

xftang@allinkbio.com

+8618502921630

Facility Contacts

Dr. Udit Nindra

Role: primary

Other Identifiers

ALK201-01

Identifier Type: -

Identifier Source: org_study_id