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Recruiting NCT07281326

A Study of AK138D1 in Advanced Malignant Tumors

Phase I Interventional Solid Cancer

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: AK138D1.
Who it may be relevant to
Registry conditions: Solid Cancer. 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
China
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 Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AK138D1 in Advanced Solid Tumors

Overview

This is a Phase I clinical trial testing the safety and effectiveness of AK138D1in patients with advanced cancer. The study will enroll up to 200 patients with various types of advanced solid tumors who haven't responded to standard treatments. Patients will receive AK138D1 to determine the safest dose and evaluate if the drug can help treat their cancer.

Detailed description

This open-label, dose-escalation and expansion Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of AK138D1 in subjects with advanced malignant tumors. The study will test different doses of AK138D1 to find the recommended dose for future studies and assess whether the drug shows signs of effectiveness against cancer. Participants will receive AK138D1 through intravenous infusion and will be closely monitored for side effects and treatment response. The final number of participants enrolled will depend on the safety and effectiveness results observed during the study.

Interventions

  • Drug AK138D1
    Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.

Primary outcome measures

  • Adverse events (AEs) [Time frame: Up to approximately 2 years]
  • Dose-Limiting Toxicity (DLT) [Time frame: Up to approximately 2 years]
Secondary outcome measures (9)
  • Peak Plasma Concentration (Cmax) of AK138D1 [Time frame: Up to approximately 2 years]
  • Area under the plasma concentration versus time curve (AUC) of AK138D1 [Time frame: Up to approximately 2 years]
  • Anti-drug antibodies (ADA) [Time frame: Up to approximately 2 years]
  • Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
  • Disease Control Rate (DCR) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
  • Duration of response (DoR) assessed by the investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
  • Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
  • Time to response (TTR) assessed by the investigator per RECIST v1.1 [Time frame: Up to approximately 2 years]
  • Overall Survival (OS) [Time frame: Up to approximately 2 years]

Eligibility criteria

Inclusion criteria

  • The subject must sign the written informed consent form (ICF) voluntarily;
  • At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
  • ECOG performance status score of 0 or 1;
  • Has a life expectancy of ≥ 3 months;
  • At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
  • Adequate organ function.

Exclusion criteria

  • Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;
  • Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
  • Presence of active central nervous system (CNS) metastases.
  • Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
  • Untreated subjects with active hepatitis B or active hepatitis C;
  • Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
  • Known active syphilis infection;
  • Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
  • Other reasons for ineligibility as evaluated by the investigator.

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
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Harbin Medical University Cancer Hospital — Harbin

Identifiers

NCT: NCT07281326 · AK138D1-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗