Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06656390

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cancer Care Wollongong, Wollongong, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALK201

Drug

Administered intravenously, once every 3 weeks

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.

    Time frame: Approximately 36 months

    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.

Secondary outcomes

  1. To evaluate the pharmacokinetics (PK) of ALK201.

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)

  2. To evaluate the pharmacokinetics (PK) of ALK201

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)

  3. To evaluate the pharmacokinetics (PK) of ALK201

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)

  4. To evaluate the pharmacokinetics (PK) of ALK201

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)

  5. To evaluate the pharmacokinetics (PK) of ALK201

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: trough Concentration(Ctrough)

  6. To evaluate the pharmacokinetics (PK) of ALK201

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: Clearance(CL)

  7. To evaluate the pharmacokinetics (PK) of ALK201

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: apparent Distribution Volume(Vd)

  8. To evaluate the pharmacokinetics (PK) of ALK201

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)

  9. To evaluate the pharmacokinetics (PK) of ALK201

    Time frame: Approximately 36 months

    PK parameters after single and multiple doses: terminal half-life (t1/2)

  10. To evaluate the immunogenicity of ALK201.

    Time frame: Approximately 36 months

    The generation of anti-drug antibodies (ADAs).

  11. To evaluate the preliminary antitumor activity of ALK201

    Time frame: Approximately 36 months

    Objective Response Rate (ORR)

  12. To evaluate the preliminary antitumor activity of ALK201

    Time frame: Approximately 36 months

    Duration of Response (DOR)

  13. To evaluate the preliminary antitumor activity of ALK201

    Time frame: Approximately 36 months

    Disease Control Rate (DCR)

  14. To evaluate the preliminary antitumor activity of ALK201

    Time frame: Approximately 36 months

    Progression-Free Survival (PFS)

  15. To evaluate the preliminary antitumor activity of ALK201

    Time frame: Approximately 36 months

    Overall Survival (OS)

  16. To evaluate the biomarkers.

    Time frame: Approximately 36 months

    Descriptive analysis will be made to describe the correlation between clinical outcomes and FGFR2 genetic alterations.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Allink Biotherapeutics Co., Ltd.

Industry

Registry information

Official study title

A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 24, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.