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

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.

Conditions

Advanced Cancer, Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

Margate

D&H Cancer Research Center Llc, Margate, Florida, United States, 33063

Fairfax

Next Oncology, 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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shanghai Allink Biotherapeutics Co., Ltd.,

Study Record Dates

2028-12