Solid Tumors
Conditions
Brief summary
This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.
Interventions
DRUG7MW4911
7MW4911 for IV infusion of various dose strengths administered
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18\ 75. 2. ECOG 0-1. 3. Life expectancy ≥ 3 months. 4. Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors. 5. Disease progression after the most recent treatment regimen. 6. At least one measurable lesion according to RECIST v1.1. 7. Provision of archival tumor tissue or fresh biopsy. 8. Adequte hematologic funciton, liver function and renal function. 9. Comply with contraceptive requirements.
Exclusion criteria
1. Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ. 2. Active, untreated or symptomatic CNS metastasis. 3. Effusions that require frequent drainage. 4. Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment. 5. Severe respiratory disease that required hospitalization in the last 28 days. 6. Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration. 7. Poorly controlled blood glucose with fasting blood glucose above 10 mmol/L. 8. Recipient of allogeneic stem cell transplant or organ transplant 9. Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration. 10. Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies. 11. Prohibited treatment and treatment that requires washout period: (1) Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy. (2) Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration. (3) Major surgeries within 28 days prior to study drug administration. (4) Investigational therapy within 28 days prior to study drug administration. (5) Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed. (6) Use of strong CYP3A4 inhibitor or inducer. 12. Known hypersensitivity to 7MW4911 or components of the formulation. 13. Abuse of narcotic or psychoactive drugs. 14. Pregnant or breastfeeding women. 15. Other circumstances or conditions where the investigator judges to be unsuitable for study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and rates of adverse events | Up to approximately 2 years | To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors |
| Maximum tolerated dose (MTD), recommended expansion dose (RED) and the recommended phase II dose (RP2D) | Up to approximately 2 years | To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | Up to approximately 2 years | Incidence and rates of ADA |
| Tmax | Up to 3 months | Time to maximum concentration of 7MW4911 in blood |
| Objective response rate | Up to approximately 2 years | Proportion of patients whose turmor response meet the criteria of complete response or partial response |
| t1/2 | Up to 3 months | Time to decrease of 7MW4911 concentration by 50% in blood |
| Area under the curve | Up to 3 months | Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) |
| Cmax | Up to 3 months | Maximum concentration of 7MW4911 in bloood |
| Progression-free survival | Up to approximately 2 years | Duration in months from treatment to disease progression or death from any cause, whichever occurs first. |
Countries
China
Contacts
Primary ContactLei Cong
Outcome results
None listed