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

NCT06656390 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ALK201-01
• Study Type: interventional
• Target: 202
• Locations: 3 countries
• Sites: 38

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

Keywords

First-in-human

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.

  Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.

  Approximately 36 months

Secondary Outcomes (16)

• To evaluate the pharmacokinetics (PK) of ALK201.

  Approximately 36 months

• To evaluate the pharmacokinetics (PK) of ALK201

  Approximately 36 months

• To evaluate the pharmacokinetics (PK) of ALK201

  Approximately 36 months

• To evaluate the pharmacokinetics (PK) of ALK201

  Approximately 36 months

• To evaluate the pharmacokinetics (PK) of ALK201

  Approximately 36 months

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: ALK201

Interventions

ALK201 DRUG

Administered intravenously, once every 3 weeks

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Allink Biotherapeutics Co., Ltd.: lead

Study Sites (38)

Denver Drug Development Unit

Denver, Colorado, 80218, United States

RECRUITING

UCF Lake Nona Cancer Center

Orlando, Florida, 32827, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Cancer Care Wollongong

Wollongong, New South Wales, 2500, Australia

RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

RECRUITING

Mater Cancer Care Center

South Brisbane, Queensland, Australia

RECRUITING

Macquarie University Hospital

Macquarie, Australia

RECRUITING

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospital Of Xiamen University

Xiamen, Fujian, China

RECRUITING

Guangdong Province People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Cancer Hospital Of Shantou University Medical College

Shantou, Guangdong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

RECRUITING

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

RECRUITING

Harbin Medical University Canser Hospital

Harbin, Heilongjiang, China

RECRUITING

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

RECRUITING

Tongji Hospital, Tongji Medical College of Hust

Wuhan, Hubei, China

RECRUITING

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

RECRUITING

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Xuzhou Central Hospital ( Southeast University Affiliated Hopstal )

Xuzhou, Jiangsu, China

RECRUITING

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medical

Hangzhou, Zhejiang, China

RECRUITING

The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

RECRUITING

ChongQing University Cancer Hospital

Chongqing, China

RECRUITING

Central Study Contacts

ALK Tang

CONTACT

+8618502921630; xftang@allinkbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 24, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): October 22, 2027
• Study Completion (Estimated): April 22, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-03

Locations

CN (30); AU (4); US (4)