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

March 9, 2025 updated by: Shanghai Allink Biotherapeutics Co., Ltd.

A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
  • United States
    • Florida
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Cancer Research Center LLC
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and women ≥18 and ≤75 years old on the day of signing the ICF
  • At least 1 measurable lesion per RECIST v1.1
  • Expected survival ≥3 months
  • ECOG PS score of 0 or 1
  • Adequate organ function
  • Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) 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.

Exclusion Criteria:

  • Received organ transplant or hematopoietic stem cell transplant previously
  • Vaccinated with live vaccines within 4 weeks prior to the first dose
  • Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
  • Pregnant or lactating women
  • Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.
  • Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: ALK202
Administered intravenously, once every 3 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
Approximately 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: trough Concentration(Ctrough)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: Clearance(CL)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: apparent Distribution Volume(Vd)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)
Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202
Time Frame: Approximately 36 months
PK parameters after single and multiple doses: terminal half-life (t1/2)
Approximately 36 months
To evaluate the immunogenicity of ALK202
Time Frame: Approximately 36 months
The generation of anti-drug antibodies (ADAs)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time Frame: Approximately 36 months
Objective Response Rate (ORR)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time Frame: Approximately 36 months
Duration of Response (DOR)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time Frame: Approximately 36 months
Disease Control Rate (DCR)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time Frame: Approximately 36 months
Progression-Free Survival (PFS)
Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202
Time Frame: Approximately 36 months
Overall Survival (OS)
Approximately 36 months
To evaluate the biomarkers
Time Frame: Approximately 36 months
To explore the correlation between biomarkers (EGFR/c-MET) and the efficacy and other clinical outcomes/parameters of ALK202
Approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Allink Biotherapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALK202-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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