ALK201
DrugAdministered intravenously, once every 3 weeks
NCT Number: NCT06656390
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Cancer Care Wollongong, Wollongong, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Administered intravenously, once every 3 weeks
Time frame: 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.
Time frame: 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)
Time frame: Approximately 36 months
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: Approximately 36 months
PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)
Time frame: Approximately 36 months
PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)
Time frame: Approximately 36 months
PK parameters after single and multiple doses: trough Concentration(Ctrough)
Time frame: Approximately 36 months
PK parameters after single and multiple doses: Clearance(CL)
Time frame: Approximately 36 months
PK parameters after single and multiple doses: apparent Distribution Volume(Vd)
Time frame: Approximately 36 months
PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)
Time frame: Approximately 36 months
PK parameters after single and multiple doses: terminal half-life (t1/2)
Time frame: Approximately 36 months
The generation of anti-drug antibodies (ADAs).
Time frame: Approximately 36 months
Objective Response Rate (ORR)
Time frame: Approximately 36 months
Duration of Response (DOR)
Time frame: Approximately 36 months
Disease Control Rate (DCR)
Time frame: Approximately 36 months
Progression-Free Survival (PFS)
Time frame: Approximately 36 months
Overall Survival (OS)
Time frame: Approximately 36 months
Descriptive analysis will be made to describe the correlation between clinical outcomes and FGFR2 genetic alterations.
Contact information is provided by the study sponsor or research team.
Shanghai Allink Biotherapeutics Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07127874
Advanced Cancer, Advanced Solid Tumors
Los Angeles, California, United States
View Trial DetailsNCT06239467
Advanced Cancer, Advanced Solid Tumors
Encinitas, California, United States
View Trial DetailsNCT02628067
Adenocarcinoma, Adenoma
View Trial DetailsNCT05663710
Adenocarcinoma, Advanced Cancer
Houston, Texas, United States
View Trial Details