Advanced Esophageal Cancer, Advanced Lung Cancer
Conditions
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
Interventions
DRUGMC002（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
Sponsors
Hangzhou MacroLink Biopharmaceutical LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the Number of patients with Adverse Events (AE) | 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 | From enrollment until 28 days after last study drug | Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (Cmax) | From enrollment until 28 days after last study drug | The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived). |
| ADA | From enrollment until 28 after last study drug | Incidence, onset time, and titer of ADAs against MC002 |
| The time taken to reach the maximum concentration (Tmax) | From enrollment until 28 days after last study drug | The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived). |
| Area Under Curve (AUC) | From enrollment until 28 days after last study drug | PK endpoint |
| Half life (T1/2) | From enrollment until 28 days after last study drug | Half life (T1/2) |
| Trough concentration (Cmin) | From enrollment until 28 days after last study drug | The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived) |
Contacts
CONTACTMedical Director
Outcome results
None listed