A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
Shanghai Allink Biotherapeutics Co., Ltd.
Study ID
NCT06656390
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ALK201 — DRUG
    Administered intravenously, once every 3 weeks

Study Details

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.

Key Dates

Start date
Oct 24, 2024
Status verified
Mar 2026
Primary completion
Oct 22, 2027
Completion
Apr 22, 2028

Study Design

Enrollment
202 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose-escalation Phase, Part B: Dose-expansion Phase
    A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B). A dose-expansion study which will enroll the select indications.

Primary Outcome 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. [ Time Frame: Approximately 36 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Denver Drug Development UnitDenverColorado80218
Dr.Jason Henry
UCF Lake Nona Cancer CenterOrlandoFlorida32827
Dr.Cesar Perez
University Medical Center New OrleansNew OrleansLouisiana70112
Dr. Shou-Ching Tang
Sarah Cannon Research Institute Oncology PartnersNashvilleTennessee37203
Dr. Meredith Pelster

Find similar trials in Denver, CO

By research site
Denver Drug Development Unit· Denver, COUCF Lake Nona Cancer Center· Orlando, FLUniversity Medical Center New Orleans· New Orleans, LASarah Cannon Research Institute Oncology Partners· Nashville, TN

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