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RecruitingInterventionalPhase 1

A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors

NCT ID: NCT06707610Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.Last updated: 2025-03-12

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.

Arms & interventions

  • DrugALK202

    Administered intravenously, once every 3 weeks

Outcome measures

Primary

  • To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 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.

    Time frame: Approximately 36 months

Secondary

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Time frame: Approximately 36 months

  • To evaluate the immunogenicity of ALK202

    Time frame: Approximately 36 months

  • To evaluate the preliminary antitumor activity of ALK202

    Time frame: Approximately 36 months

  • To evaluate the preliminary antitumor activity of ALK202

    Time frame: Approximately 36 months

  • To evaluate the preliminary antitumor activity of ALK202

    Time frame: Approximately 36 months

  • To evaluate the preliminary antitumor activity of ALK202

    Time frame: Approximately 36 months

  • To evaluate the preliminary antitumor activity of ALK202

    Time frame: Approximately 36 months

  • To evaluate the biomarkers

    Time frame: Approximately 36 months

Eligibility criteria

Sex: AllAge: 18 Years to 75 YearsHealthy volunteers: No
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 is a female of childbearing potential agree to use medically effective contraceptive methods (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms. 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 nervous system and/or metastases to meninges * Pregnant or lactating women * Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage. * Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study locations (2)

D&H Cancer Research Center Llc

Margate, Florida, 33063

Recruiting
Dr. David Kahn · Contact

Next Oncology

Fairfax, Virginia, 22031

Recruiting
Dr. Alex Apira · Contact
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors | Cancerify