NCT06707610

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_1

Timeline
30mo left

Started Feb 2025

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Feb 2025Dec 2028

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

November 25, 2024

Last Update Submit

March 9, 2025

Conditions

Advanced CancerAdvanced Solid Tumor

Keywords

First-in-human

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • To evaluate the pharmacokinetics (PK) of ALK202

    Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Approximately 36 months

  • To evaluate the pharmacokinetics (PK) of ALK202

    Approximately 36 months

  • +11 more secondary outcomes

Study Arms (1)

Part A: Dose-escalation Phase Part B: Dose-expansion Phase

EXPERIMENTAL

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

Interventions

ALK202DRUG

Administered intravenously, once every 3 weeks

Part A: Dose-escalation Phase Part B: Dose-expansion Phase

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

D&H Cancer Research Center Llc

Margate, Florida, 33063, United States

RECRUITING

Next Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

RECRUITING

Macquarie University

Sydney, New South Wales, 2109, Australia

RECRUITING

Central Study Contacts

Shuntong Duan

CONTACT

8618005141727stduan@allinkbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 27, 2024

Study Start

February 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

AU(2)US(2)