A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors

Part of paid clinical trials in Margate, Florida.

Sponsor
Shanghai Allink Biotherapeutics Co., Ltd.
Study ID
NCT06707610
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • ALK202 — DRUG
    Administered intravenously, once every 3 weeks

Study Details

TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.

Key Dates

Start date
Feb 10, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
234 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 ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies. [ Time Frame: Approximately 36 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
D&H Cancer Research Center LlcMargateFlorida33063
Dr. David Kahn
[email protected]
+1 9543232422
Next OncologyFairfaxVirginia22031
Dr. Alex Apira
[email protected]
+1 7032805390

Find similar trials in Margate, FL

By research site
D&H Cancer Research Center Llc· Margate, FLNext Oncology· Fairfax, VA

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