Advanced MalignancyPhase 1SDX-0101NCT02743637
A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
A Phase 1 study testing SDX-7320 in people with Advanced Malignancy and Advanced Solid Tumors, run by SynDevRx, Inc. at 3 sites in United States.
Trial summary
This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Advanced Malignancy, Advanced Solid Tumors, Neoplasm
- What is being tested?
- SDX-7320
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2016to 16 Dec 2019
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have at least one site of radiographically measurable disease.
- Eastern Cooperative Oncology Group (ECOG) status ≤1.
- Adequate renal and liver functions.
- Life expectancy ≥3 months.
Who cannot join
- Patients that have undergone organ transplant surgery.
- The patient has a known history of Hepatitis A, B, or C and is on active anti-viral therapy.
- History of gastric bypass surgery or banding procedure.
- Uncontrolled or refractory hypertension: systolic >180 or diastolic >110, or hypotension: systolic <90 or diastolic <50 despite medical treatment.
- Participation in any other trial of an investigational agent within 30 days prior to first dose of study drug.
- The resting 12-lead electrocardiogram obtained during screening shows QTc (Fridericia correction) ≥470 ms or has a congenital prolonged QT syndrome.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cedars Sinai Medical Center
Los Angeles, California, 90048
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1 Dose Escalation Study of SDX-7320 to Assess the Safety and Tolerability in Patients With Advanced Refractory or Late-Stage Solid Tumors
This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.
Read the detailed description
This is a Phase 1 dose escalation study to assess the safety and tolerability of subcutaneously administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.
Once the MTD has been determined up to 12 patients will be treated at this dose level, to further characterize treatment emergent adverse events (TEAEs).
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Neoplasm, Metastasis
- Being tested
- SDX-7320
- Keywords
- Cancer, Oncology, Solid Tumors, Phase 1, SDX-7320, SynDevRx, MetAP2, Breast, Post menopausal, Colorectal, Pancreatic, Ovarian, Endometrial, Esophageal, Lung, Renal, Prostate, Liver
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDX-7320Drug
SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| SDX-7320 | Experimental | Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined. Receives: Drug: SDX-7320 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose
Measured: Up to 30 days after last subject enrolled
Secondary outcomes (1)
Anti-tumor activity
RECIST v1.1
Measured: From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignancyStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- SynDevRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neal Salomon, MD, Study director, SynDevRx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743637
- Sponsor's protocol ID
- SDX-0101
- Acronym
- SDX-0101
- Status last verified
- Jan 2020
- First submitted
- 7 Apr 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of SDX-7320 to Assess the Safety and Tolerability in Patients With Advanced Refractory or Late-Stage Solid Tumors
- ClinicalTrials.gov ID
- NCT02743637
- Acronym / sponsor ID
- SDX-0101 / SDX-0101
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Neoplasm, Metastasis
- Keywords
- Cancer, Oncology, Solid Tumors, Phase 1, SDX-7320, SynDevRx, MetAP2, Breast
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SynDevRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 19 Apr 2016 (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 Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.
Detailed description
This is a Phase 1 dose escalation study to assess the safety and tolerability of subcutaneously administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.
Once the MTD has been determined up to 12 patients will be treated at this dose level, to further characterize treatment emergent adverse events (TEAEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SDX-7320 | Experimental | Drug: SDX-7320Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients have at least one site of radiographically measurable disease.
- Eastern Cooperative Oncology Group (ECOG) status ≤1.
- Adequate renal and liver functions.
- Life expectancy ≥3 months.
Key exclusion criteria (6 listed)
- Patients that have undergone organ transplant surgery.
- The patient has a known history of Hepatitis A, B, or C and is on active anti-viral therapy.
- History of gastric bypass surgery or banding procedure.
- Uncontrolled or refractory hypertension: systolic >180 or diastolic >110, or hypotension: systolic <90 or diastolic <50 despite medical treatment.
- Participation in any other trial of an investigational agent within 30 days prior to first dose of study drug.
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 |
|---|---|---|
| SDX-7320SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor. | Drug | SDX-7320 |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose
Time frame: Up to 30 days after last subject enrolled
1 secondary outcome
Anti-tumor activity
Time frame: From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks
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 27 Jan 2020.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Neal Salomon, MD study director
SynDevRx, Inc.
3 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 SDX-7320 in people with Advanced Malignancy and Advanced Solid Tumors, run by SynDevRx, Inc. at 3 sites 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 4 inclusion and 6 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose (time frame: Up to 30 days after last subject enrolled). 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 27 Jan 2020.