Phase I/II clinical trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of BEY1107 in Monotherapy and in Combination With Gemcitabine in Patient with Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0003140
- Lead Sponsor
- BeyondBio Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
1)Subjects who have histopathologically or cytologically diagnosed with pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
2)Subjects with one or more lesions that are measurable or evaluable with RECIST v1.1
3)Subjects with an eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
4)Subjects with a life expectancy of at least 12 weeks as determined by an investigator
5)Subjects with appropriate bone marrow, renal, and liver function at screening
1) History of treatment of locally advanced or metastatic pancreatic cancer
2) Where major surgery (e.g., surgery requiring general anesthesia, etc.) was performed, subjects for whom at least 4 weeks have not elapsed since the surgery as of the time of screening
3) Subjects with an evidence for symptomatic uncontrolled brain metastasis (brain metastasis is permitted if it is radiologically and neurologically stable after stopping corticosteroid administration for at least 2 weeks prior)
4) Subjects with an active bacterial infection who have been administered antibiotics within 7 days prior to screening (excluding local antibiotic treatment)
5) Subjects with a history of malignant tumor other than basal cell carcinoma, cervix carcinoma in situ, and papillary thyroid cancer within 5 years prior to screening
6) Pregnant women, breastfeeding women, and women of childbearing potential
7) Subjects infected with HIV or active hepatitis B or C (provided that subjects in whom the virus is not detected may be enrolled)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (Phase I);Disease control rate (Phase II);Number of DLT(Dose Limiting Toxicity) in each cohort (Phase I)
- Secondary Outcome Measures
Name Time Method Pharmacokinetic assessment (Phase I);Disease control rate (Phase I);Objective response rate (Phase II);safety assessment (Phase II);Pharmacodynamic assessment (Phase II)