A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors

Last updated: March 9, 2025
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Metastatic Cancer

Neoplasms

Treatment

ALK202

Clinical Study ID

NCT06707610
ALK202-01
  • Ages 18-75
  • All Genders

Study Summary

TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.

Eligibility Criteria

Inclusion

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

  • ECOG PS score of 0 or 1

  • Adequate organ function

  • Female participants of childbearing potential or male participants whose partner isa female of childbearing potential agree to use medically effective contraceptivemethods (abstinence, birth control pills, barrier contraception, intra-uterinecontraceptive device, etc.) from the date of signing the ICF until at least 6 monthsafter the last dose of ALK202, and during this period, male participants are notallowed to donate sperms.

Exclusion

Exclusion Criteria:

  • Received organ transplant or hematopoietic stem cell transplant previously

  • Vaccinated with live vaccines within 4 weeks prior to the first dose

  • Primary central nervous system malignancies, or active metastases to central nervoussystem and/or metastases to meninges

  • Pregnant or lactating women

  • Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied withclinical symptoms, clinically poorly controlled, or requiring repeated drainage.

  • Evidence of other severe or uncontrolled systemic diseases (e.g., decompensatedrespiratory disorder, hepatic disease, or renal disease).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 234
Treatment Group(s): 1
Primary Treatment: ALK202
Phase: 1
Study Start date:
February 10, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Scientia Clinical Research Ltd

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Macquarie University

    Sydney, New South Wales 2109
    Australia

    Active - Recruiting

  • D&H Cancer Research Center Llc

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Next Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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