Advanced Unresectable Solid TumorsPhase 1NCT02508441
Phase 1 Safety and Tolerability Study of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors
A Phase 1 study testing Andes-1537 for Injection in people with Advanced Unresectable Solid Tumors, run by Andes Biotechnologies at 1 site in United States.
Trial summary
This is a first-in-human, open-label, dose escalation and expansion, 2-part study to determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in patients with advanced unresectable 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
- Advanced Unresectable Solid Tumors
- 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2015to 13 Nov 2017
- 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 prior to any study-related assessments or procedures, and are able to adhere to the study visit schedule and other protocol requirements
- Patient with documented pathological evidence of a cancer from which has developed advanced unresectable solid tumors that are, in the opinion of their treating physician, refractory to standard therapy or for which no standard therapy is available
- Consent to tumor biopsy from accessible tissue (optional in Part 1 and mandatory in Part 2)
- Have measureable disease by RECIST
- Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Show all 9Show fewer
- Have adequate organ function, confirmed by the following laboratory values obtained ≤ 3 days prior to the first treatment: absolute neutrophil count ≥ 1.5 × 10^9/L; hemoglobin ≥ 9 g/dL; platelets ≥ 100 × 10^9/L; aspartate transaminase and alanine transaminase ≤ 2.5 × upper limit of normal (ULN); serum total bilirubin ≤ 2.0 × ULN; serum creatinine ≤ 1.5 × ULN, or estimated or measured creatinine clearance ≥ 60 mL/min; prothrombin time, activated partial thromboplastin time ≤ 1.5 × ULN if not on anticoagulation therapy
- Female patients of childbearing potential must have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug.
- Male patients at screening must agree to practice adequate contraception from study entry through at least 6 months after discontinuation of study drug.
Who cannot join
- Have symptomatic central nervous system metastases. Patients with brain metastases that have been previously treated and are stable for ≥ 4 weeks or treated with gamma knife surgery and are stable for ≥ 2 weeks are allowed to enter the study.
- Have unstable angina, clinically significant cardiac arrhythmia, New York Heart Association Class 3 or 4 congestive heart failure, or prolonged QT interval corrected 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 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
Show all 11Show fewer
- Have had DVT or venous thromboembolism within 6 weeks of 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center at Mount Zion, Helen Diller Family Comprehensive Cancer Center, Early Phase Clinical Trials
San Francisco, California, 94115
About this study
Official title: A Phase 1 Open-label First-in-human Dose-escalating Safety and Tolerability Study Evaluating Subcutaneous Administration of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy is Available
This is a first-in-human, open-label, dose escalation and expansion, 2-part study to determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available.
Read the detailed description
Part 1 is a dose-escalation study to establish the maximum tolerated dose based on dose-limiting toxicities and to evaluate the safety and tolerability of multiple doses of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available. Part 2 is an open-label, dose-expansion study to determine the safety, tolerability, and preliminary efficacy of Andes-1537 in patients with advanced solid tumors. In part 2, patients will be enrolled and receive the recommended phase 2 dose established in part 1 based on the safety, tolerability, pharmacokinetics, and preliminary efficacy data.
- Conditions
- Advanced Unresectable Solid Tumors
- Being tested
- Andes-1537 for Injection
- Keywords
- Neoplasms, Solid Tumors, Advanced Malignancy, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andes-1537 for InjectionDrug
Part 1: Andes-1537 subcutaneous injection, 100 to 1000 mg twice a week per 4-week cycle
Part 2: Andes-1537 subcutaneous injection, recommended phase 2 dose administered twice a week per 4-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Andes-1537 for Injection | Experimental | Part 1 is an open-label, dose-escalation study. Part 2 is an open-label, dose-expansion study. 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 dose-limiting toxicities
Determine maximum tolerated dose
Measured: First 4-week treatment cycle
Secondary outcomes (9)
Adverse events
Incidence of treatment-emergent adverse events
Measured: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Safety laboratory tests
Changes in baseline safety laboratory tests
Measured: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Physical examinations
Changes in baseline physical examination
Measured: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Vital signs
Changes in baseline vital signs
Measured: Safety evaluations will be measured through 28 days after last dose of Andes-1537
12-lead electrocardiogram (ECG)
Changes in baseline ECG
Measured: First 4-week treatment cycle
Injection site reactions
Incidence of injection site reactions
Measured: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Pharmacokinetic parameters in Andes-1537 in blood and urine for single-dose and multiple-dose evaluation
Measure maximum concentration, time to maximum concentration, area under the curve, clearance, volume of distribution, and half-life
Measured: Pre-treatment, following first dose and last dose of cycle 1 (4-week cycle), first dose of each additional cycle through study completion, and last visit
Pharmacodynamic parameters in blood and biopsy samples from accessible tissue
Evaluate biomarkers in tissue and blood
Measured: Pre-treatment and at 4 and 8 weeks for biopsy; blood samples at pre-treatment, every 8 weeks, and last visit
Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) with CT or MRI scan
Changes in tumor size from baseline measurements
Measured: Every 8 weeks following completion of 2 treatment cycles to cover from date of initiation until date of first documented progression or toxicity to Andes-1537, which ever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start8 Dec 2015
- Primary completion13 Nov 2017
- Study completion13 Nov 2017
Why it stopped: Part 1 of the study was completed and the maximum tolerated dose determined. Part 2 of the study was terminated and will be conducted under a new protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Unresectable Solid TumorsStudies 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andes Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Munster, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508441
- Sponsor's protocol ID
- AB1537-001
- Status last verified
- Oct 2018
- First submitted
- 15 Jul 2015
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label First-in-human Dose-escalating Safety and Tolerability Study Evaluating Subcutaneous Administration of Andes-1537 for Injection in Patients With Advanced Unresectable Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy is Available
- ClinicalTrials.gov ID
- NCT02508441
- Acronym / sponsor ID
- AB1537-001
- Conditions
- Advanced Unresectable Solid Tumors
- Keywords
- Neoplasms, Solid Tumors, Advanced Malignancy, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part 1 of the study was completed and the maximum tolerated dose determined. Part 2 of the study was terminated and will be conducted under a new protocol.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Andes BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 27 Jul 2015 (estimated)
- 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.
This is a first-in-human, open-label, dose escalation and expansion, 2-part study to determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available.
Detailed description
Part 1 is a dose-escalation study to establish the maximum tolerated dose based on dose-limiting toxicities and to evaluate the safety and tolerability of multiple doses of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available. Part 2 is an open-label, dose-expansion study to determine the safety, tolerability, and preliminary efficacy of Andes-1537 in patients with advanced solid tumors. In part 2, patients will be enrolled and receive the recommended phase 2 dose established in part 1 based on the safety, tolerability, pharmacokinetics, and preliminary efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Andes-1537 for Injection | Experimental | Drug: Andes-1537 for InjectionPart 1 is an open-label, dose-escalation study. Part 2 is an open-label, dose-expansion study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women 18 years of age or older
- Can understand and voluntarily sign an informed consent form prior to any study-related assessments or procedures, and are able to adhere to the study visit schedule and other protocol requirements
- Patient with documented pathological evidence of a cancer from which has developed advanced unresectable solid tumors that are, in the opinion of their treating physician, refractory to standard therapy or for which no standard therapy is available
- Consent to tumor biopsy from accessible tissue (optional in Part 1 and mandatory in Part 2)
- Have measureable disease by RECIST
Key exclusion criteria (11 listed)
- Have symptomatic central nervous system metastases. Patients with brain metastases that have been previously treated and are stable for ≥ 4 weeks or treated with gamma knife surgery and are stable for ≥ 2 weeks are allowed to enter the study.
- Have unstable angina, clinically significant cardiac arrhythmia, New York Heart Association Class 3 or 4 congestive heart failure, or prolonged QT interval corrected 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 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 InjectionPart 1: Andes-1537 subcutaneous injection, 100 to 1000 mg twice a week per 4-week cycle Part 2: Andes-1537 subcutaneous injection, recommended phase 2 dose administered twice a week per 4-week cycle | Drug | Andes-1537 for Injection |
Primary outcome
Incidence of dose-limiting toxicities
Time frame: First 4-week treatment cycle
Determine maximum tolerated dose
9 secondary outcomes
Adverse events
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Safety laboratory tests
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Physical examinations
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Vital signs
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
12-lead electrocardiogram (ECG)
Time frame: First 4-week treatment cycle
Injection site reactions
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Pharmacokinetic parameters in Andes-1537 in blood and urine for single-dose and multiple-dose evaluation
Time frame: Pre-treatment, following first dose and last dose of cycle 1 (4-week cycle), first dose of each additional cycle through study completion, and last visit
Pharmacodynamic parameters in blood and biopsy samples from accessible tissue
Time frame: Pre-treatment and at 4 and 8 weeks for biopsy; blood samples at pre-treatment, every 8 weeks, and last visit
Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) with CT or MRI scan
Time frame: Every 8 weeks following completion of 2 treatment cycles to cover from date of initiation until date of first documented progression or toxicity to Andes-1537, which ever comes first
Results and safety
The study was stopped early (reason given: Part 1 of the study was completed and the maximum tolerated dose determined. Part 2 of the study was terminated and will be conducted under a new protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Advanced Unresectable Solid Tumors
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
Active, not recruitingPhase 3
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruitingPhase 2
Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
RecruitingPhase 1
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Breast Cancer, Ovarian Cancer
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.
Pamela Munster, MD principal investigator
University of California, San Francisco
1 site 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 Advanced Unresectable Solid Tumors, run by Andes Biotechnologies at 1 site in United States.
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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Part 1 of the study was completed and the maximum tolerated dose determined. Part 2 of the study was terminated and will be conducted under a new protocol.). Results are not available in the source record.
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 dose-limiting toxicities (time frame: First 4-week treatment cycle). 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 18 Oct 2018.