Tumor, SolidPhase 1NCT03985072
Study With Andes-1537 in Patients With Specific Types of Advanced Solid Tumor
A Phase 1 study testing Andes-1537 for Injection in people with Tumor, Solid and Gall Bladder Cancer, run by Andes Biotechnologies at 4 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid, Gall Bladder Cancer, Cervical Cancer
- What is being tested?
- Andes-1537 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesChile
- Study dates
- 26 Apr 2019to 17 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Chile4 sites
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, 7500921
Centro de Cancer de Nuestra Senora de la Esperanza, Red de Salud UC CHRISTUS
Santiago, Santiago Metropolitan, 8330032
Instituto Nacional del Cáncer (INCANCER)
Santiago, Santiago Metropolitan, 8380455
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, V Region de Valparaiso, 2540364
About this study
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
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.
Read the 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.
- Conditions
- Tumor, Solid, Gall Bladder Cancer, Cervical Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer
- Being tested
- Andes-1537 for Injection
- Keywords
- Neoplasm, Solid Tumor, Cancer, Carcinoma
- Medical subject headings
- Neoplasms, Gallbladder Neoplasms, Uterine Cervical Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andes-1537 for InjectionDrug
Andes-1537 administered subcutaneously five days per week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Andes-1537 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
CT or MRI of tumor every 8 weeks and compared to previous RECIST assessment
Measured: 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
CT or MRI of tumor every 8 weeks and compared to previous RECIST assessment
Measured: 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
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.
Measured: 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)
Plasma samples will be collected in each treatment cycle for evaluation of AUC
Measured: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
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
Measured: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
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
Measured: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
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
Measured: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
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.
Measured: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start26 Apr 2019
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andes Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernadita Mendez, PhD, Study director, Andes Biotechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985072
- Sponsor's protocol ID
- AB1537-002
- Status last verified
- Feb 2022
- First submitted
- 17 May 2019
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03985072
- Acronym / sponsor ID
- AB1537-002
- Conditions
- Tumor, Solid, Gall Bladder Cancer, Cervical Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer
- Keywords
- Neoplasm, Solid Tumor, Cancer, Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Andes BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Andes-1537 | Experimental | Drug: Andes-1537 for InjectionThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Have measurable disease by RECIST.
- Have Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 1.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andes-1537 for InjectionAndes-1537 administered subcutaneously five days per week. | Drug | Andes-1537 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) through stages 1 and 2 of the study
Time frame: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from 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
9 secondary outcomes
Objective response rate (ORR) according to RECIST
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)
Duration of response and duration of stable disease according to RECIST
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)
Progression free survival time according to RECIST
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)
Andes-1537 tumor-cell biomarker activity in biopsy tissue
Time frame: 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)
Time frame: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter maximum plasma concentration (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)
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter time to maximum concentration (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)
Plasma concentration of Andes-1537 after subcutaneous administration for PK parameter half-life (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)
Incidence of Andes-1537 anti-drug antibodies (ADAs) in the plasma
Time frame: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernadita Mendez, PhD study director
Andes Biotechnologies
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Andes-1537 for Injection in people with Tumor, Solid and Gall Bladder Cancer, run by Andes Biotechnologies at 4 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) through stages 1 and 2 of the study (time frame: Screening and during cycle treatment (each cycle 4 weeks) until study completion (approximately 24 weeks or earlier if patient discontinues from study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.