ALK202 for Cancer

Recruiting at 3 trial locations

Overseen By Shuntong Duan

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

234 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

I am between 18 and 75 years old.

Expected survival of at least 3 months

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Part A: Dose-escalation Phase Part B: Dose-expansion Phase Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Shanghai Allink Biotherapeutics Co., Ltd.

Lead Sponsor

Trials

2

Recruited

440+