A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALK202.
- Who it may be relevant to
- Registry conditions: Advanced Cancer, Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Interventions
- Drug ALK202
Administered intravenously, once every 3 weeks
Primary outcome measures
- 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]
Secondary outcome measures (12)
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the pharmacokinetics (PK) of ALK202 [Time frame: Approximately 36 months]
- To evaluate the immunogenicity of ALK202 [Time frame: Approximately 36 months]
- To evaluate the preliminary antitumor activity of ALK202 [Time frame: Approximately 36 months]
- To evaluate the preliminary antitumor activity of ALK202 [Time frame: Approximately 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- D&H Cancer Research Center Llc — Margate
- Next Oncology — Fairfax
Australia · 2 centers
- Scientia Clinical Research Ltd — Randwick
- Macquarie University — Sydney
Identifiers
NCT: NCT06707610 · ALK202-01