202 Participants NeededMy employer runs this trial

ALK201 for Cancer

Recruiting at 37 trial locations
XT
AT
Overseen ByALK Tang
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a new treatment, ALK201, for individuals with advanced solid tumors. Researchers seek to determine the safety and tolerability of this drug and its potential to shrink tumors. The trial will help establish the optimal dose for future studies. Candidates may qualify if they have an advanced solid tumor with at least one measurable lesion, an expected survival of at least three months, and no active autoimmune diseases. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Do I have to stop taking my current medications for the ALK201 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ALK201 is likely to be safe for humans?

Research has shown that ALK201, which targets a protein called FGFR2b, was generally well-tolerated by patients in earlier studies. This treatment is currently being tested on individuals with advanced solid tumors. Although detailed safety information is still being collected, its progression through early trials suggests it is deemed safe enough for further study. As ALK201 undergoes its first tests in humans, understanding its safety remains a key focus, and researchers are closely monitoring for any side effects.12345

Why do researchers think this study treatment might be promising for cancer?

ALK201 is unique because it targets the anaplastic lymphoma kinase (ALK) pathway, which is a new approach compared to traditional chemotherapy and radiation therapies. Researchers are excited about ALK201 because it has the potential to specifically block cancer cell growth while minimizing harm to normal cells, reducing the side effects often seen with standard treatments. This targeted action could lead to more effective treatments for patients with cancers driven by ALK mutations.

What evidence suggests that ALK201 might be an effective treatment for cancer?

Research has shown that ALK201 targets a protein called FGFR2b, which is linked to many solid tumors. In lab studies, ALK201 effectively killed tumor cells with this protein. It also demonstrated the ability to affect nearby cancer cells that might not have the protein, a phenomenon known as bystander killing. This method aims to slow tumor growth by targeting a key factor that helps cancer cells survive. Although human studies provide limited information, these early findings suggest that ALK201 could be a promising treatment for advanced solid tumors. Participants in this trial will first undergo a dose-escalation phase to determine the maximum tolerated dose, followed by a dose-expansion phase to further evaluate its effects.12346

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors who have at least one tumor that can be measured, are expected to live at least 3 months, have good organ function, and are generally in good physical condition. Participants must agree to use effective birth control during the study.

Inclusion Criteria

I have at least one tumor that can be measured.
My doctor expects me to live for at least 3 more months.
I am fully active or restricted in physically strenuous activity only.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation Phase

A dose-escalation study to determine the maximum tolerated dose (MTD) and the subsequent doses for dose expansion study

Approximately 36 months

Dose-expansion Phase

A dose-expansion study which will enroll the select indications

Approximately 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALK201

Trial Overview

The study is testing a new drug called ALK201 given alone to see how safe it is, what side effects it causes, how the body processes it, and if it helps shrink tumors. The trial will find the best dose for future studies.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Part A: Dose-escalation Phase, Part B: Dose-expansion PhaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shanghai Allink Biotherapeutics Co., Ltd.

Lead Sponsor

Trials
2
Recruited
440+

Citations

Abstract LB227: ALK201, a first-in-class FGFR2b-targeting ...

ALK201 showed efficient internalization, potent killing of FGFR2b+ tumor cells, and a strong bystander killing activity. ALK201 significantly ...

NCT06656390 | A Study to Evaluate the Safety, Tolerability ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult ...

U.S. FDA IND Clearance and First Patient Dosed in ...

ALK201 is an innovative ADC candidate targeting FGFR2b a critical oncogenic driver that has demonstrated clinical validation in various solid tumors.

ALK-201 - Drug Targets, Indications, Patents

... ALK201 for Injection in Adult Participants With Advanced Solid Tumors. 100 Clinical Results associated with ALK-201. Login to view more data.

Retrospective Real-World Outcomes for Patients With ALK ...

Clinical trials have firmly established that ALK TKIs are safe, well tolerated, and effective; these findings reveal that their impact in a real-world setting ...

A Study to Evaluate the Safety, Tolerability ...

A Phase 1 study of ALK201 in advanced solid tumors. A study to evaluate the safety and effectiveness of an investigational drug called ALK201 in treating ...