Trial NCT07216560
First-in-human Study of 7MW4911 in GI Cancer
- Phase
- Phase 1/2
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Conditions
- GI Cancers
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
1. Aged 18 and above
2. ECOG 0-1Performance status
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.Prior malignancy
2. Active, untreated or symptomatic CNS metastasisBrain metastases
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/LDiabetes
8. Recipient of allogeneic stem cell transplant or organ transplant
9. Active HIV or hepatitis B/C infection.HIV 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 womenPregnancy
15. Other circumstances or conditions where the investigator judges to be unsuitable for study.
Restrictions found (6)
- Brain metastasesConditionalexclusionShow in the text
- DiabetesConditionalexclusion
fasting blood glucose > 10 mmol/L
Show in the text - HIVOutrightexclusionShow in the text
- Performance statusConditionalinclusion
ECOG 0-1
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyConditionalexclusion
within 3 years
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County