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

Official record

Identifier

NCT07726212

Recruiting locations

Locations are not included in the offline baseline for this record. Open the official record to see the current site list.

Interventions studied

MC002（ADC）

Lead sponsor

Hangzhou MacroLink Biopharmaceutical LLC

Target enrolment

143 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Not yet recruiting

First posted

Jul 24, 2026

Last updated on the registry

Jul 27, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Esophageal Cancer