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Trial Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants with Advanced Solid Tumors
NCT ID:
NCT06656390
Condition:
Advanced Cancer
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
First-in-human
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ALK201
Description:
Administered intravenously, once every 3 weeks
Arm group label:
Part A: Dose-escalation Phase, Part B: Dose-expansion Phase
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 22, 2024
Completion date:
April 22, 2028
Lead sponsor:
Agency:
Shanghai Allink Biotherapeutics Co., Ltd.
Agency class:
Industry
Source:
Shanghai Allink Biotherapeutics Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06656390
