Study With Andes-1537 in Patients With Specific Types of Advanced Solid Tumor
NCT03985072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2022-02-24
Summary
The study is a Phase 1 Open-label Two-stage, Safety and Tolerability Study with Cancer Type-specific Cohorts, Evaluating Subcutaneous Administration of Andes-1537 for Injection in Patients with Advanced Solid Tumors that are Refractory to Standard Therapy or For Which No Standard Therapy Is Available. Patients with unresectable solid tumors that are refractory or have failed standard therapy and are deemed non-eligible or intolerant to further therapy or for which no standard therapy is available will be included in 5 cancer type-specific parallel cohorts. The following tumor types will be evaluated for potential inclusion in each cancer type-specific cohort: gallbladder \& biliary tract carcinoma; cervical carcinoma; gastric carcinoma; pancreatic carcinoma, and colorectal carcinoma.
Conditions
- Tumor, Solid
- Gall Bladder Cancer
- Cervical Cancer
- Gastric Cancer
- Pancreatic Cancer
- Colorectal Cancer
Interventions
- DRUG
-
Andes-1537 for Injection
Andes-1537 administered subcutaneously five days per week.
Sponsors & Collaborators
-
Andes Biotechnologies
lead INDUSTRY
Principal Investigators
-
Bernadita Mendez, PhD · Andes Biotechnologies
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-26
- Primary Completion
- 2022-02-17
- Completion
- 2022-02-17
- FDA Drug
- Yes
Countries
- Chile
Study Locations
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