Clinical trial NCT06656390: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Advanced Solid Tumors
Keywords: First-in-human
Lead sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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

Primary outcomes:
measure: 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.
timeFrame: Approximately 36 months
Secondary outcomes:
measure: To evaluate the pharmacokinetics (PK) of ALK201.
timeFrame: Approximately 36 months
measure: To evaluate the pharmacokinetics (PK) of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the pharmacokinetics (PK) of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the pharmacokinetics (PK) of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the pharmacokinetics (PK) of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the pharmacokinetics (PK) of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the pharmacokinetics (PK) of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the pharmacokinetics (PK) of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the pharmacokinetics (PK) of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the immunogenicity of ALK201.
timeFrame: Approximately 36 months
measure: To evaluate the preliminary antitumor activity of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the preliminary antitumor activity of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the preliminary antitumor activity of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the preliminary antitumor activity of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the preliminary antitumor activity of ALK201
timeFrame: Approximately 36 months
measure: To evaluate the biomarkers.
timeFrame: Approximately 36 months
Other outcomes:
Locations:
city: Wollongong
country: Australia
facility: Cancer Care Wollongong
state: New South Wales
Study officials:
References: