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

NCT07726212 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MC002 FIH StudySponsor
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Esophageal Cancer; Advanced Lung Cancer

Outcome Measures

Primary Outcomes (2)

• To assess the Number of patients with Adverse Events (AE)

  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

  Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002

  From enrollment until 28 days after last study drug

Secondary Outcomes (6)

• Maximum concentration (Cmax)

  From enrollment until 28 days after last study drug

• ADA

  From enrollment until 28 after last study drug

• The time taken to reach the maximum concentration (Tmax)

  From enrollment until 28 days after last study drug

• Area Under Curve (AUC)

  From enrollment until 28 days after last study drug

• Half life (T1/2)

  From enrollment until 28 days after last study drug

Other Outcomes (2)

• Overall response rate (ORR）

  From enrollment until 28 days after last study drug.

• progression-free survival (PFS)

  From enrollment until 28 days after last study drug.

Study Arms (1)

dose escalation

EXPERIMENTAL

MC002 dose escalation

Drug: MC002（ADC）

Interventions

MC002（ADC） DRUG

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

dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangzhou MacroLink Biopharmaceutical LLC: lead

Central Study Contacts

Medical Director

CONTACT

+86 13306139991; ke.chen@mlkbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07