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

Primary Purpose

Tumor, Solid, Gall Bladder Cancer, Cervical Cancer

Status
Completed
Phase
Phase 1
Locations
Chile
Study Type
Interventional
Intervention
Andes-1537 for Injection
Sponsored by
Andes Biotechnologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumor, Solid focused on measuring Neoplasm, Solid Tumor, Cancer, Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women 18 years of age or older.
  2. 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.
  3. 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.
  4. Have measurable disease by RECIST.
  5. Have Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 1.
  6. Have life expectancy ≥ 12 weeks as judged by the investigator.
  7. 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
    • Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) ≥ 2.5 × upper limit of normal (ULN)
    • Serum total bilirubin ≤ 2.0 × ULN
    • Serum creatinine ≤ 1.5 × ULN (patients with Creatinine > 1,5 x ULN may be considered to participate if estimated or measured creatinine clearance ≥ 60 mL/min)
    • Prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 ULN if not on anticoagulation therapy (patients receiving anticoagulation therapy must be in the therapeutic range and stable for ≥ 4 weeks prior to study entry)
  8. Patients with accessible tumor tissue, susceptible to biopsies through procedures such as colonoscopy, endoscopy, endocervical biopsy (among others), are required to provide consent for two biopsies throughout the study, to analyze tumor biomarkers. The first tumor biopsy will be performed in these patients in a timeframe of 28 days prior to the initial administration of the investigational product Andes-1537. Alternatively, pathological archived material may be used, if the biopsy was collected within a period of two months prior to initiation of treatment and with no anti-cancer treatment performed since the collection date. The second biopsy will be performed after 2 cycles (8 weeks) of treatment. If no archival material is available, and only one lesion is amenable for biopsy (and is the only target lesion), the Medical Monitor should be consulted for subject eligibility. Tumor biopsies and tumor archival material must be suitable for biomarker assessment as described in the Laboratory Manual.
  9. Female patients of childbearing potential must have a negative serum pregnancy test and be using adequate contraception (defined below) prior to study entry and must agree to continue to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Note: Options for adequate contraception with a failure rate of <1% per year include: tubal ligation, male sterilization, hormonal implants, established proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and cervical cap) may be combined to achieve a failure rate of <1% per year. Barrier methods must always be supplemented with the use of a spermicide. Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not acceptable methods of contraception. Should a female patient or a female partner of a male patient become pregnant or suspect she is pregnant while participating in the study or within 6 months following discontinuation of the study drug, the patient should inform the investigator immediately.

Exclusion Criteria:

  1. Have known central nervous system metastases.
  2. 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.
  3. Receiving treatment with any medication known to produce QT prolongation within 7 days of study entry.
  4. 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).
  5. Have had major surgery ≤ 2 weeks prior to starting treatment with Andes-1537 or who have not recovered from side effects of such surgery.
  6. Are pregnant or breastfeeding.
  7. 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.
  8. Have active uncontrolled bleeding or a known bleeding disorder.
  9. 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.
  10. Have a known sensitivity to any of the components of Andes-1537.
  11. Are unable or unwilling to follow protocol instructions and requirements.
  12. 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.

Sites / Locations

  • Fundacion Arturo Lopez Perez
  • Centro de Cancer de Nuestra Senora de la Esperanza, Red de Salud UC CHRISTUS
  • Instituto Nacional del Cáncer (INCANCER)
  • Centro de Investigaciones Clinicas Vina del Mar

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Andes-1537

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective response rate (ORR) according to RECIST
Computed tomography (CT) or magnetic resonance imaging (MRI) scan of tumors located in chest, abdomen, and pelvis every 8 weeks for change in tumor size from baseline measurements
Duration of response and duration of stable disease according to RECIST
CT or MRI of tumor every 8 weeks and compared to previous RECIST assessment
Progression free survival time according to RECIST
CT or MRI of tumor every 8 weeks and compared to previous RECIST assessment
Andes-1537 tumor-cell biomarker activity in biopsy tissue
Biopsies will be performed at screening prior to treatment and at the end of the second cycle of treatment in tumor tissue that is accessible by procedures such as colonoscopy, endoscopy, endocervical biopsy, etc. Tumor biopsy samples will be assessed for biomarkers of Andes-1537 activity through histology assays.
Plasma concentration of Andes-1537 after subcutaneous administration for pharmacokinetic (PK) parameter area under the plasma concentration versus time (AUC)
Plasma samples will be collected in each treatment cycle for evaluation of AUC
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter maximum plasma concentration (Cmax)
Plasma samples will be collected in each treatment cycle for evaluation of Cmax
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter time to maximum concentration (Tmax)
Plasma samples will be collected in each treatment cycle for evaluation of Tmax
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter half-life (t1/2)
Plasma samples will be collected in each treatment cycle for evaluation of t1/2
Incidence of Andes-1537 anti-drug antibodies (ADAs) in the plasma
Assessment of immunogenicity of Andes-1537 following subcutaneous administration by determining the presence of Andes-1537 ADAs in all patients receiving at least 2 treatment cycles. Blood samples will be collected and stored for future analysis of ADAs prior to the first injection of cycle 1 and then every 8 weeks following completion of a treatment cycle, prior to beginning the next cycle, and end-of-study visit.

Full Information

First Posted
May 17, 2019
Last Updated
February 23, 2022
Sponsor
Andes Biotechnologies
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1. Study Identification

Unique Protocol Identification Number
NCT03985072
Brief Title
Study With Andes-1537 in Patients With Specific Types of Advanced Solid Tumor
Official Title
Phase 1 Open-label Two-stage Safety and Tolerability Study With Subcutaneous Administration of Andes-1537 for Injection in Patients With Specific Types of Advanced Solid Tumors That Are Refractory To or No Available Standard Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andes Biotechnologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
After screening, 9 patients in each cancer type-specific cohort (gallbladder & biliary tract carcinoma; cervical carcinoma; gastric carcinoma; pancreatic carcinoma, and colorectal carcinoma) will enter stage 1. These patients will receive a dose of 400 mg of Andes-1537 five times per week for continuous cycles of 4 weeks that will be repeated until the patients presents drug toxicity requiring treatment discontinuation or disease progression with no noted clinical benefit as assessed by the investigator. The safety and tolerability evaluation will be continuous during the study. The efficacy evaluation will be done by analysis of the clinical objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria after patients complete the first two cycles (8 weeks). Thereafter, clinical ORR will be assessed every 8 weeks. Additionally, tumor-cell activity assessment will be performed in biopsy samples after the patients complete the first 2 cycles (8 weeks). Tumor markers assessment according to the type of tumor will be evaluated every 2 cycles and at the end of study (EOS) visit. Analysis of the tumor metabolic activity through the PET-CT scan and quality of life of patients through questionnaire will be evaluated every 2 cycles. As predefined and according with the decision of the Study Safety and Steering Committee (SSC), in those cohorts where minimal clinical response criteria were met or according to the decision of the SSC based on the risk / benefit analysis, considering toxicity criteria and observed biological responses, 15 additional patients will be recruited (total of 24 patients per cohort) for stage 2 of the study. Patients included in stage 2 will receive the same treatment regimen described for stage 1 and will be followed until the patients present disease progression or drug toxicity requiring treatment discontinuation. Patients included in stage 2 will receive the same follow-up as patients in stage 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Solid, Gall Bladder Cancer, Cervical Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer
Keywords
Neoplasm, Solid Tumor, Cancer, Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Andes-1537
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Andes-1537 for Injection
Intervention Description
Andes-1537 administered subcutaneously five days per week.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) through stages 1 and 2 of the study
Description
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
Time Frame
Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) according to RECIST
Description
Computed tomography (CT) or magnetic resonance imaging (MRI) scan of tumors located in chest, abdomen, and pelvis every 8 weeks for change in tumor size from baseline measurements
Time Frame
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)
Title
Duration of response and duration of stable disease according to RECIST
Description
CT or MRI of tumor every 8 weeks and compared to previous RECIST assessment
Time Frame
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)
Title
Progression free survival time according to RECIST
Description
CT or MRI of tumor every 8 weeks and compared to previous RECIST assessment
Time Frame
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)
Title
Andes-1537 tumor-cell biomarker activity in biopsy tissue
Description
Biopsies will be performed at screening prior to treatment and at the end of the second cycle of treatment in tumor tissue that is accessible by procedures such as colonoscopy, endoscopy, endocervical biopsy, etc. Tumor biopsy samples will be assessed for biomarkers of Andes-1537 activity through histology assays.
Time Frame
Screening to end of cycle 2 (each cycle 4 weeks) treatment (approximately 8 weeks)
Title
Plasma concentration of Andes-1537 after subcutaneous administration for pharmacokinetic (PK) parameter area under the plasma concentration versus time (AUC)
Description
Plasma samples will be collected in each treatment cycle for evaluation of AUC
Time Frame
Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Title
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter maximum plasma concentration (Cmax)
Description
Plasma samples will be collected in each treatment cycle for evaluation of Cmax
Time Frame
Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Title
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter time to maximum concentration (Tmax)
Description
Plasma samples will be collected in each treatment cycle for evaluation of Tmax
Time Frame
Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Title
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter half-life (t1/2)
Description
Plasma samples will be collected in each treatment cycle for evaluation of t1/2
Time Frame
Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Title
Incidence of Andes-1537 anti-drug antibodies (ADAs) in the plasma
Description
Assessment of immunogenicity of Andes-1537 following subcutaneous administration by determining the presence of Andes-1537 ADAs in all patients receiving at least 2 treatment cycles. Blood samples will be collected and stored for future analysis of ADAs prior to the first injection of cycle 1 and then every 8 weeks following completion of a treatment cycle, prior to beginning the next cycle, and end-of-study visit.
Time Frame
Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Other Pre-specified Outcome Measures:
Title
Evaluate exploratory response of patient quality of life assessment
Description
Patients to complete quality of life questionnaire
Time Frame
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)
Title
Evaluate the exploratory tumor response of metabolic activity
Description
Tumor metabolic activity determined by positron emission tomography (PET) plus CT
Time Frame
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)
Title
Evaluate the exploratory response of inflammatory markers
Description
Change in plasma concentration from baseline of markers of inflammation for C-reactive protein and complement activity will be evaluated during the first cycle, every 2 weeks. After the first cycle, checked once per month following completion of a treatment cycle and prior to beginning the next cycle.
Time Frame
Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Title
Evaluate the exploratory response of tumor markers
Description
Change in plasma concentration of tumor markers cancer antigen (CA) 19-9 in biliary tract cancer and pancreatic carcinoma and carcinoembryonic antigen (CEA) tumor marker in colorectal carcinoma.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) ≥ 2.5 × upper limit of normal (ULN) Serum total bilirubin ≤ 2.0 × ULN Serum creatinine ≤ 1.5 × ULN (patients with Creatinine > 1,5 x ULN may be considered to participate if estimated or measured creatinine clearance ≥ 60 mL/min) Prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 ULN if not on anticoagulation therapy (patients receiving anticoagulation therapy must be in the therapeutic range and stable for ≥ 4 weeks prior to study entry) Patients with accessible tumor tissue, susceptible to biopsies through procedures such as colonoscopy, endoscopy, endocervical biopsy (among others), are required to provide consent for two biopsies throughout the study, to analyze tumor biomarkers. The first tumor biopsy will be performed in these patients in a timeframe of 28 days prior to the initial administration of the investigational product Andes-1537. Alternatively, pathological archived material may be used, if the biopsy was collected within a period of two months prior to initiation of treatment and with no anti-cancer treatment performed since the collection date. The second biopsy will be performed after 2 cycles (8 weeks) of treatment. If no archival material is available, and only one lesion is amenable for biopsy (and is the only target lesion), the Medical Monitor should be consulted for subject eligibility. Tumor biopsies and tumor archival material must be suitable for biomarker assessment as described in the Laboratory Manual. Female patients of childbearing potential must have a negative serum pregnancy test and be using adequate contraception (defined below) prior to study entry and must agree to continue to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Note: Options for adequate contraception with a failure rate of <1% per year include: tubal ligation, male sterilization, hormonal implants, established proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and cervical cap) may be combined to achieve a failure rate of <1% per year. Barrier methods must always be supplemented with the use of a spermicide. Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not acceptable methods of contraception. Should a female patient or a female partner of a male patient become pregnant or suspect she is pregnant while participating in the study or within 6 months following discontinuation of the study drug, the patient should inform the investigator immediately. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadita Mendez, PhD
Organizational Affiliation
Andes Biotechnologies
Official's Role
Study Director
Facility Information:
Facility Name
Fundacion Arturo Lopez Perez
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Centro de Cancer de Nuestra Senora de la Esperanza, Red de Salud UC CHRISTUS
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Instituto Nacional del Cáncer (INCANCER)
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Centro de Investigaciones Clinicas Vina del Mar
City
Vina del Mar
State/Province
V Region De Valparaiso
ZIP/Postal Code
2540364
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

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

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