234 Participants Needed

ALK202 for Cancer

Recruiting at 3 trial locations
SD
Overseen ByShuntong Duan
Age: 18+
Sex: Any
Trial Phase: Phase 1
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 tests a new treatment called ALK202, a potential drug for people with advanced solid tumors. The main goal is to determine if ALK202 is safe and to establish the right dose for future studies. Participants should have cancer that has spread and can be measured by doctors, and they should feel well enough to perform daily activities.

As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding how it works in people.

Do I have to stop taking my current medications for the ALK202 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 ALK202 is likely to be safe for humans?

Research is examining the safety and tolerability of ALK202 in individuals with advanced solid tumors. This marks the first human trial of ALK202, so no prior safety data from human studies exists. As a Phase 1 trial, the primary goal is to assess safety and determine the optimal dose for future studies. Phase 1 trials focus on safety, with close monitoring of any side effects. Although specific safety data is not yet available, the study is designed to carefully observe participants' responses to the treatment.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about ALK202 because it offers a novel approach to cancer treatment by targeting specific genetic mutations involved in tumor growth. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, ALK202 is designed to specifically inhibit the anaplastic lymphoma kinase (ALK) pathway, potentially leading to more precise and effective treatment with fewer side effects. This targeted mechanism could mean better outcomes for patients whose cancers are driven by these genetic alterations, making ALK202 a promising new option in the fight against cancer.

What evidence suggests that ALK202 might be an effective treatment for advanced solid tumors?

Research has shown that ALK202 might be a promising treatment for advanced solid tumors. Early results suggest that ALK202, which targets proteins that aid tumor growth, could help shrink tumors. This trial studies ALK202 to assess its safety and effectiveness in halting cancer progression. Although human studies provide limited information, the mechanism of ALK202 offers hope for slowing or stopping tumor growth. Early research focuses on understanding how the body processes the drug and its overall impact on tumors.12678

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with advanced solid tumors, measurable by standard criteria, who have a life expectancy of at least 3 months and are in relatively good physical condition. They must have functioning organs and agree to use effective contraception. Those who can't join include women who may be pregnant or breastfeeding.

Inclusion Criteria

At least 1 measurable lesion per RECIST v1.1
Expected survival of at least 3 months
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 ALK202, and during this period, male participants are not allowed to donate sperms.
See 2 more

Exclusion Criteria

Pregnant or lactating women
I have had an organ or stem cell transplant.
I do not have severe illnesses like serious lung, liver, or kidney diseases.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of ALK202 to determine the maximum tolerated dose (MTD)

Approximately 12 months

Dose-expansion

Participants receive the recommended dose of ALK202 to further evaluate safety and antitumor activity

Approximately 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALK202
Trial Overview ALK202 is being tested as a solo treatment for people with advanced solid tumors. This first-in-human study will assess the drug's safety, how well it's tolerated, its behavior in the body (pharmacokinetics), and its ability to fight cancer.
How Is the Trial Designed?
1Treatment 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

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics ...The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult ...
EGFR/cMET Bispecific ADC Program - ALK202 Received ...Currently ALK202 is being evaluated in a global multicenter Phase I clinical trial to assess its efficacy and safety profile in advanced solid ...
ALK202 for Cancer ยท Recruiting Participants for Phase ...The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult ...
ALK Inhibitor Treatment Patterns and Outcomes in Real ...We sought to assess the overall treatment pattern characteristics, safety, and effectiveness outcomes of real-world patients with ALK-positive aNSCLC receiving ...
A humanized anaplastic lymphoma kinase (ALK)-directed ...Notably, NB-SD tumors treated with daily lorlatinib demonstrated progressive tumor growth and 0% overall survival, while NB-SD tumors treated ...
A Study to Evaluate the Safety, Tolerability ...The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in ...
ALK-202 - Drug Targets, Indications, PatentsA First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 ...
A Study to Evaluate the Safety, Tolerability ...The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in ...
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