GI Cancers
Conditions
Brief summary
This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
Interventions
DRUG7MW4911
study drug
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 and above 2. ECOG 0-1 3. Life expectancy ≥ 3 months 4. Advanced or metastatic gastrointestinal cancer that has progressed after standard of care. 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 10mmol/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 |
| MTD, RED, and 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 |
|---|---|---|
| Tmax of 7MW4911 | up to 3 months | time to maximum concentration of 7MW4911 in blood |
| Cmax of 7MW4911 | up to 3 months | maximum concentration of 7MW4911 in bloood |
| Half life of 7MW4911 | up to 3 months | time to decrease of 7MW4911 concentration by 50% in blood |
| Area under the curve of 7MW4911 | up to 3 months | Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) |
| Objective response rate | Up to approximately 2 years | proportion of patients whose turmor response meet the criteria of complete response or partial response |
| Progression-free survival | up to approximately 2 years | Duration in months from enrollment to first disease progression |
| Immunogenicity of 7MW4911 | Up to approximately 2 years | Incidence and rates of ADA |
Countries
United States
Contacts
CONTACTXiu Wang
CONTACTWenhui Zhang
Outcome results
None listed