Recruiting
Phase 1
Phase 2

ALK201

Sponsor:

Shanghai Allink Biotherapeutics Co., Ltd.

Code:

NCT06656390

Conditions

Advanced Cancer

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALK201

Study Details

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 ID

NCT06656390

Start date

Oct 24, 2024

Status verified date

Mar, 2026

Completion date

Apr 22, 2028

Anticipated

Primary completion date

Oct 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Enrollment

202 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

ALK201

Administered intravenously, once every 3 weeks

Primary outcome measure

  • 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. [ Time Frame: Approximately 36 months ]

Central Contacts and Locations

Central contacts

ALK Tang

+8618502921630xftang@allinkbio.com

Locations

Denver Drug Development Unit

Recruiting

Denver, Colorado, United States, 80218

UCF Lake Nona Cancer Center

Recruiting

Orlando, Florida, United States, 32827

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Sarah Cannon Research Institute Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

Shanghai Allink Biotherapeutics Co., Ltd.

Last update posted

May 22, 2026

Last verified

Mar, 2026

Keywords

  • First-in-human

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shanghai Allink Biotherapeutics Co., Ltd. on 2026-05-22.