Advanced Esophageal CancerPhase 1NCT07726212
A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
A Phase 1 study testing MC002（ADC） in people with Advanced Esophageal Cancer and Advanced Lung Cancer, run by Hangzhou MacroLink Biopharmaceutical LLC.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Esophageal Cancer, Advanced Lung Cancer
- What is being tested?
- MC002（ADC）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- MC002（ADC）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | MC002 dose escalation Receives: Drug: MC002（ADC） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From enrollment until 28 days after last study drug
Secondary outcomes (6)
Maximum concentration (Cmax)
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Measured: From enrollment until 28 days after last study drug
ADA
Incidence, onset time, and titer of ADAs against MC002
Measured: From enrollment until 28 after last study drug
The time taken to reach the maximum concentration (Tmax)
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
Measured: From enrollment until 28 days after last study drug
Area Under Curve (AUC)
PK endpoint
Measured: From enrollment until 28 days after last study drug
Half life (T1/2)
Half life (T1/2)
Measured: From enrollment until 28 days after last study drug
Trough concentration (Cmin)
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived)
Measured: From enrollment until 28 days after last study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou MacroLink Biopharmaceutical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726212
- Sponsor's protocol ID
- MC002 FIH Study
- Other IDs
- Sponsor
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07726212
- Acronym / sponsor ID
- MC002 FIH Study
- Conditions
- Advanced Esophageal Cancer, Advanced Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Hangzhou MacroLink Biopharmaceutical LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation | Experimental | Drug: MC002（ADC）MC002 dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | dose escalation |
Primary outcome
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.
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MC002（ADC） in people with Advanced Esophageal Cancer and Advanced Lung Cancer, run by Hangzhou MacroLink Biopharmaceutical LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (+86 13306139991, ke.chen@mlkbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.