A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
ClinicalTrials ID:NCT06656390
This first-in-human, open-label study assesses ALK201's safety, tolerability, PK, and antitumor activity in adults with advanced solid tumors. Participants must be 18-75 years old, have at least one measurable lesion, an ECOG PS of 0 or 1, and adequate organ function. ALK201 is administered intravenously every three weeks. Contraceptive use is required for participants of childbearing potential.
Patient Parameters
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Program Overview
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.
Eligibility Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Denver Drug Development Unit | 80218 | Denver | Colorado |
| UCF Lake Nona Cancer Center | 32827 | Orlando | Florida |
| University Medical Center New Orleans | 70112 | New Orleans | Louisiana |
| Sarah Cannon Research Institute Oncology Partners | 37203 | Nashville | Tennessee |
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