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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985072 on ClinicalTrials.gov