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Not yet recruiting NCT07726212

A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002

Phase I Interventional Advanced Esophageal Cancer Advanced Lung 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: MC002（ADC）.
Who it may be relevant to
Registry conditions: Advanced Esophageal Cancer, Advanced Lung Cancer. Basic parameters: from 18 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
Center list to be confirmed — check the primary protocol.
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 (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of MC002 in Participants With Locally Advanced/Metastatic Solid Tumors

Overview

The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are: Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002 . Participants will: Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms

Interventions

  • Drug MC002（ADC）
    MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.A complete treatment cycle is defined as 21 calendar days. MC002 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle

Primary outcome measures

  • To assess the Number of patients with Adverse Events (AE) [Time frame: From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up]
  • Determination of MTD or RP2D [Time frame: From enrollment until 28 days after last study drug]
Secondary outcome measures (6)
  • Maximum concentration (Cmax) [Time frame: From enrollment until 28 days after last study drug]
  • ADA [Time frame: From enrollment until 28 after last study drug]
  • The time taken to reach the maximum concentration (Tmax) [Time frame: From enrollment until 28 days after last study drug]
  • Area Under Curve (AUC) [Time frame: From enrollment until 28 days after last study drug]
  • Half life (T1/2) [Time frame: From enrollment until 28 days after last study drug]
  • Trough concentration (Cmin) [Time frame: From enrollment until 28 days after last study drug]

Eligibility criteria

Inclusion criteria

  • 18 years of age and over, male or female, able to understand and willing to sign the Informed Consent Form (ICF).
  • Life expectancy of 3 month or greater
  • participants with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy.
  • At least one measurable lesion as assessed by RECIST 1.1
  • Adequate organ functions.
  • ECOG Performance Status (PS) of 0-1

Exclusion Criteria：

  • Pregnant or nursing females.Participants who have received chemotherapy, investigational therapy, immunotherapy, or any other antitumor active drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
  • Known hypersensitivity to either the drug substances or inactive ingredient
  • Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
  • Participants with QTc >470 msec.
  • Use of ≥10 mg of prednisone or equivalent dose of steroids per day within 3 months of administration (inhaled, intranasal, intraocular, topical and intraarticular joint injections of corticosteroids are allowed).Participants with a history of HCV infection who have not completed curative anti HCV treatment and whose HCV load is above the limit of quantification. Concurrent HCV treatment is not allowed in the trial.Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
  • Participants who have received treatment with any herbal or alternative therapies within 7 days prior to the first dose of the study drug.
  • Male and female participants of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07726212 · MC002 FIH Study · Sponsor

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗