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NCT Number: NCT07726212

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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).

  2. ADA

    Time frame: From enrollment until 28 after last study drug

    Incidence, onset time, and titer of ADAs against MC002

  3. 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).

  4. Area Under Curve (AUC)

    Time frame: From enrollment until 28 days after last study drug

    PK endpoint

  5. Half life (T1/2)

    Time frame: From enrollment until 28 days after last study drug

    Half life (T1/2)

  6. 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)

Other outcomes

  1. 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。

  2. progression-free survival (PFS)

    Time frame: From enrollment until 28 days after last study drug.

    assessed per RECISTv1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

+86 13306139991

Sponsors and collaborators

Lead sponsor

Hangzhou MacroLink Biopharmaceutical LLC

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 24, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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