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

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: Recruiting
• Conditions: Advanced Solid Tumor; Advanced Cancer
• Intervention / Treatment: Drug: ALK202

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shuntong Duan; Phone Number: 8618005141727; Email: stduan@allinkbio.com

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Scientia Clinical Research Ltd
      • Contact: Dr. Charlotte Lemech; Phone Number: +61 2 93825807; Email: Charlotte.lemech@scientiaclinicalresearch.com.au
    • Sydney, New South Wales, Australia, 2109
      • Recruiting
      • Macquarie University
      • Contact: Dr. John Park; Phone Number: +61 2 98123000; Email: John.park@mqhealth.org.au
• United States
  • Florida
    • Margate, Florida, United States, 33063
      • Recruiting
      • D&H Cancer Research Center LLC
      • Contact: Dr. David Kahn; Phone Number: +1 9543232422; Email: Drdkahn@dhnrc.com
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Oncology
      • Contact: Dr. Alex Apira; Phone Number: +1 7032805390; Email: aspira@nextoncology.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

Outcome Measure	Measure Description	Time Frame
To evaluate the pharmacokinetics (PK) of ALK202	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	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	PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)	Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202	PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)	Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202	PK parameters after single and multiple doses: trough Concentration(Ctrough)	Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202	PK parameters after single and multiple doses: Clearance(CL)	Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202	PK parameters after single and multiple doses: apparent Distribution Volume(Vd)	Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202	PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)	Approximately 36 months
To evaluate the pharmacokinetics (PK) of ALK202	PK parameters after single and multiple doses: terminal half-life (t1/2)	Approximately 36 months
To evaluate the immunogenicity of ALK202	The generation of anti-drug antibodies (ADAs)	Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202	Objective Response Rate (ORR)	Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202	Duration of Response (DOR)	Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202	Disease Control Rate (DCR)	Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202	Progression-Free Survival (PFS)	Approximately 36 months
To evaluate the preliminary antitumor activity of ALK202	Overall Survival (OS)	Approximately 36 months
To evaluate the biomarkers	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

• Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: First-in-human
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID 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