NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Not Yet RecruitingPhase 1

Sponsor: Hangzhou MacroLink Biopharmaceutical LLC

Conditions: Advanced Esophageal Cancer, Advanced Lung Cancer

Interventions: MC002（ADC）

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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