Study With Andes-1537 in Patients With Specific Types of Advanced Solid Tumor

NCT03985072 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AB1537-002
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Neoplasm; Solid Tumor; Cancer; Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs) through stages 1 and 2 of the study

  Assessment of safety and tolerability through the incidence and severity of TEAEs from change in baseline for reported adverse events, safety labs, vital signs, electrocardiograms, and injection site reactions

  Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)

Secondary Outcomes (9)

• Objective response rate (ORR) according to RECIST

  Assessment performed every 8 weeks following completion of 2 treatment cycles (each cycle 4 weeks) from screening to study completion until confirmed disease progression or Andes-1537 toxicity (approximately 24 weeks or earlier if patient discontinues)

• Duration of response and duration of stable disease according to RECIST

  Assessment performed every 8 weeks following completion of 2 treatment cycles (each cycle 4 weeks) from screening to study completion until confirmed disease progression or Andes-1537 toxicity (approximately 24 weeks or earlier if patient discontinues)

• Progression free survival time according to RECIST

  Assessment performed every 8 weeks following completion of 2 treatment cycles (each cycle 4 weeks) from screening to study completion until confirmed disease progression or Andes-1537 toxicity (approximately 24 weeks or earlier if patient discontinues)

• Andes-1537 tumor-cell biomarker activity in biopsy tissue

  Screening to end of cycle 2 (each cycle 4 weeks) treatment (approximately 8 weeks)

• Plasma concentration of Andes-1537 after subcutaneous administration for pharmacokinetic (PK) parameter area under the plasma concentration versus time (AUC)

  Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)

Other Outcomes (4)

• Evaluate exploratory response of patient quality of life assessment

  Assessment performed every 8 weeks following completion of 2 treatment cycles (each cycle 4 weeks) from screening to study completion until confirmed disease progression or Andes-1537 toxicity (approximately 24 weeks or earlier if patient discontinues)

• Evaluate the exploratory tumor response of metabolic activity

  Assessment performed every 8 weeks following completion of 2 treatment cycles (each cycle 4 weeks) from screening to study completion until confirmed disease progression or Andes-1537 toxicity (approximately 24 weeks or earlier if patient discontinues)

• Evaluate the exploratory response of inflammatory markers

  Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)

Study Arms (1)

Andes-1537

EXPERIMENTAL

There will be 5 different cohorts each representing a different type of solid cancer (gallbladder and biliary tract cancer, cervical cancer, gastric cancer, pancreatic cancer, and colorectal cancer). All patients will receive a dose of 400 mg of Andes-1537 five days per week for continuous cycles of 4 weeks that will be repeated until the patients presents drug toxicity requiring treatment discontinuation or disease progression without any noted clinical benefit as assessed by the investigator.

Drug: Andes-1537 for Injection

Interventions

Andes-1537 for Injection DRUG

Andes-1537 administered subcutaneously five days per week.

Andes-1537

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18 years of age or older.
• Can understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessment or procedure, and are able to adhere to the study visit schedule and other protocol requirements.
• Patients with documented pathological evidence of advanced unresectable solid tumors that are, in the opinion of their treating physician, 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 enrolled in both stages of the study in the following 4 cancer type-specific cohorts:
• Gallbladder \& Biliary Tract Cancer: Histologically confirmed stage 4 or unresectable stage 3b biliary tract \& gallbladder adenocarcinoma with relapsed, refractory or progressive disease, who cannot tolerate or is considered resistant to platinum based chemotherapy for advanced disease such as cis-platinum and gemcitabine.
• Cervical Cancer: Histologically confirmed stages 4 or 3b cervical cancer with relapsed, refractory or progressive disease, who cannot tolerate or is considered resistant to platinum based chemotherapy for advanced disease such as cis-platinum/carboplatin and paclitaxel.
• Gastric Cancer: Histologically confirmed stage 4 or recurrent gastric adenocarcinoma with relapsed, refractory or progressive disease, who cannot tolerate or has progressed after first and second line combined chemotherapy regimens containing Epirubicin, cisplatin, fluorouracil (5-FU)/ leucovorin, oxaliplatin, irinotecan and/or docetaxel. Patients with Her2Neu positive cancer will not be eligible.
• Pancreatic Cancer: Histologically confirmed stage 4 or recurrent pancreatic adenocarcinoma with relapsed, refractory or progressive disease, who cannot tolerate or is considered resistant to combined treatment with leucovorin calcium, 5-FU, irinotecan and oxaliplatin (FOLFIRINOX) or Gemcitabine based chemotherapy, depending on age and performance status.
• Colorectal Cancer: Histologically confirmed Stage IV colorectal adenocarcinoma with relapsed, refractory, or progressive disease, who cannot tolerate or is considered resistant to combined treatment with fluoropyrimidines and/or oxaliplatin and/or irinotecan and/or Epidermal Growth Factor-1 (EGF1) inhibitors (depending on molecular profile) either as single agent or in combination therapy, depending treating oncologist´s decision. Patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) - Neuroblastoma RAS Viral Oncogene Homolog (NRAS) wild type should have progressed after cetuximab or panitunumab unless contraindicated or not available.
• Have measurable disease by RECIST.
• Have Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 1.
• Have life expectancy ≥ 12 weeks as judged by the investigator.
• Have adequate organ function, confirmed by the following laboratory values obtained ≤ 3 days prior to the first treatment:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• Hemoglobin (Hgb) ≥ 9 g/dL
• Platelets ≥ 100 × 109/L

You may not qualify if:

• Have known central nervous system metastases.
• Have unstable angina, clinically significant cardiac arrhythmia, New York Heart Association Class 3 or 4 congestive heart failure, or prolonged QT interval corrected (QTc) wave of greater than 470 ms.
• Receiving treatment with any medication known to produce QT prolongation within 7 days of study entry.
• Have had prior systemic chemotherapy treatments or investigational modalities ≤ 5 half-lives (t1/2) or 4 weeks, whichever is shorter, prior to starting treatment with Andes 1537 or who have not recovered from side effects, grade 2 or greater, of such therapy (except alopecia).
• Have had major surgery ≤ 2 weeks prior to starting treatment with Andes-1537 or who have not recovered from side effects of such surgery.
• Are pregnant or breastfeeding.
• Have had deep vein thrombosis (DVT) or venous thromboembolism within 6 weeks of study entry. Patients are permitted to enter the study if they are receiving anticoagulation therapy considered to be in the therapeutic range and are stable for ≥ 4 weeks prior to study entry.
• Have active uncontrolled bleeding or a known bleeding disorder.
• Have any serious or unstable concomitant systemic conditions that are incompatible with this clinical study, including but not limited to substance abuse, psychiatric disturbance, or uncontrolled intercurrent illness (including active infection), arterial thrombosis, or symptomatic pulmonary embolism.
• Have a known sensitivity to any of the components of Andes-1537.
• Are unable or unwilling to follow protocol instructions and requirements.
• Have received more than 2 previous lines of systemic antineoplastic treatment that includes chemotherapeutic agents, target therapies, or immunotherapy considered as standard treatments for the type of tumor that the patient has.

Sponsors & Collaborators

• Andes Biotechnologies: lead

Study Sites (4)

Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Centro de Cancer de Nuestra Senora de la Esperanza, Red de Salud UC CHRISTUS

Santiago, Santiago Metropolitan, 8330032, Chile

Location

Instituto Nacional del Cáncer (INCANCER)

Santiago, Santiago Metropolitan, 8380455, Chile

Location

Centro de Investigaciones Clinicas Vina del Mar

Viña del Mar, V Region de Valparaiso, 2540364, Chile

Location

MeSH Terms

Conditions

Neoplasms; Gallbladder Neoplasms; Uterine Cervical Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms; Carcinoma

Interventions

Injections

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Bernadita Mendez, PhD

  Andes Biotechnologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: June 13, 2019
• Study Start: April 26, 2019
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (4)