Advanced Cancer, Advanced Solid Tumors
Conditions
Keywords
First-in-human
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.
Interventions
DRUGALK201
Administered intravenously, once every 3 weeks
Sponsors
Shanghai Allink Biotherapeutics Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy 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 * 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Approximately 36 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the pharmacokinetics (PK) of ALK201. | Approximately 36 months | PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last) |
| To evaluate the pharmacokinetics (PK) of ALK201 | Approximately 36 months | PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf) |
| To evaluate the immunogenicity of ALK201. | Approximately 36 months | The generation of anti-drug antibodies (ADAs). |
| To evaluate the preliminary antitumor activity of ALK201 | Approximately 36 months | Objective Response Rate (ORR) |
| To evaluate the biomarkers. | Approximately 36 months | Descriptive analysis will be made to describe the correlation between clinical outcomes and FGFR2 genetic alterations. |
Countries
Australia, China, United States
Contacts
CONTACTALK Tang
Outcome results
None listed