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

July 20, 2026 updated by: Hangzhou MacroLink Biopharmaceutical LLC

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

143

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dose escalation
MC002 dose escalation
Drug: antibody-drug conjugate
MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Any medical event in a participant which may or may not have a causal relationship with this treatment.
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
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
From enrollment until 28 days after last study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax)
Time Frame: From enrollment until 28 days after last study drug
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
From enrollment until 28 days after last study drug
ADA
Time Frame: From enrollment until 28 after last study drug
Incidence, onset time, and titer of ADAs against MC002
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
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
From enrollment until 28 days after last study drug
Area Under Curve (AUC)
Time Frame: From enrollment until 28 days after last study drug
PK endpoint
From enrollment until 28 days after last study drug
Half life (T1/2)
Time Frame: From enrollment until 28 days after last study drug
Half life (T1/2)
From enrollment until 28 days after last study drug
Trough concentration (Cmin)
Time Frame: From enrollment until 28 days after last study drug
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived)
From enrollment until 28 days after last study drug

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR）
Time Frame: From enrollment until 28 days after last study drug.
the proportion/percentage of participants with best overall response of CR or PR。
From enrollment until 28 days after last study drug.
progression-free survival (PFS)
Time Frame: From enrollment until 28 days after last study drug.
assessed per RECISTv1.1
From enrollment until 28 days after last study drug.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou MacroLink Biopharmaceutical LLC

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 Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC002 FIH Study
  • Sponsor (Other Grant/Funding Number: Sponsor)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Esophageal Cancer

Clinical Trials on antibody-drug conjugate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe