RECRUITING

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

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Conditions

Advanced CancerAdvanced Solid TumorFirst-in-human

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-10
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06707610

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women ≥18 and ≤75 years old on the day of signing the ICF
  2. * At least 1 measurable lesion per RECIST v1.1
  3. * Expected survival ≥3 months
  4. * ECOG PS score of 0 or 1
  5. * Adequate organ function
  6. * 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.
  1. * Received organ transplant or hematopoietic stem cell transplant previously
  2. * Vaccinated with live vaccines within 4 weeks prior to the first dose
  3. * Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
  4. * Pregnant or lactating women
  5. * Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.
  6. * Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).

Contacts and Locations

Study Contact

Shuntong Duan
CONTACT
8618005141727
stduan@allinkbio.com

Study Locations (Sites)

D&H Cancer Research Center Llc
Margate, Florida, 33063
United States
Next Oncology
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2025-02-10
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • First-in-human

Additional Relevant MeSH Terms

  • Advanced Cancer
  • Advanced Solid Tumor