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NCT06707610PHASE1Recruiting

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

Shanghai Allink Biotherapeutics Co., Ltd.

Start Date

2/10/2025

Completion Date

12/1/2028

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

Age Range: 18 years to 75 years

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.

Interventions

DRUG

ALK202

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Conditions

Advanced CancerAdvanced Solid Tumor

Locations

D&H Cancer Research Center Llc

Margate, Florida 33063

United States

Next Oncology

Fairfax, Virginia 22031

United States

Scientia Clinical Research Ltd

Randwick, New South Wales 2031

Australia

Macquarie University

Sydney, New South Wales 2109

Australia