Solid TumorPhase 1NCT05037149
Ph. 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Solid Tumors
A Phase 1 study testing STP707 in people with Solid Tumor, run by Sirnaomics at 9 sites in United States.
Trial summary
An open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- STP707
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Nov 2021to 25 Apr 2024
- 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
- Subjects with histologically or cytologically confirmed advanced / metastatic or surgically unresectable solid tumors whose tumors are refractory to standard therapy
- Measurable disease per RECIST v 1.1 (primary or metastatic disease)
- ECOG performance status 0 - 1
- Life expectancy of at least 3 months
- Age ≥18 years
- Signed, written Institutional Review Board (IRB) approved informed consent
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- A negative serum pregnancy test (for nonsterile women of child-bearing potential)
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT), ALT (SGPT) ≤ 5 times upper limit of normal because of cancer or metastases to the liver
- Acceptable renal function, defined as:
- o Serum creatinine ≤ 1.5 ULN or Creatinine Clearance ≥ 50 mL/minute
- Acceptable hematologic status:
- Hemoglobin ≥ 9 g/dL (a transfusion is allowed if Hemoglobin stays stable thereafter)
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
- Platelet count ≥ 100,000 plt/mm3 x 109/ L
- Urinalysis with no clinically significant abnormalities
- Acceptable coagulation status with partial thromboplastin time (PTT) and International Normalized Ratio (INR) ≤ 1.5 times upper limit of normal unless patient is on anticoagulants and has stable PTT and PT that are within normal therapeutic range for disease under management
- Subject has adequate vitamin D level, as defined by serum total 25-Hydroxyvitamin D [25(OH)D] ≥ 20 to < 60 ng/mL. If subjects are below this threshold, they may receive vitamin D supplementation se per clinic dosing guidelines and may still be enrolled provided they are started on vitamin D supplementation
- Completion of all previous treatments (including surgery, systemic chemotherapy, and radiotherapy) at least 3 weeks before screening
- For men and women of child-producing potential, the use of effective contraceptive methods during the study
Who cannot join
- Baseline Q-T corrected interval (QTc) interval of > 470 msec for all subjects calculated using Fridericia's formula
- New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
- Known active, uncontrolled infection with HIV or hepatitis B; subjects with hepatitis B allowed if on anti-viral therapy and have a viral load ≤ 500 IU; patients with a history of HIV must be on antiretroviral therapy for at least four weeks and have an HIV viral load ≤ 400 copies/mL, have CD4+ T cell counts ≥ 350 cells/uL and no history of AIDS-defining opportunistic infections within 3 months prior to treatment
- Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure, during the course of the study. (Note: Placement of a central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure.)
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
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- Participation in a clinical study involving administration of an investigational compound within the past 30 days prior to study entry.
- Unwillingness or inability to comply with procedures required in this protocol
- Known allergy or hypersensitivity to the study drug(s) or one of the ingredients in the formulation (e.g., Trehalose dihydrate)
- Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University
Atlanta, Georgia, 30322
NEXT Oncology
Austin, Texas, 78758
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Mayo Clinic
Jacksonville, Florida, 32224
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Atlantic Health System
Morristown, New Jersey, 07960
Yale University
New Haven, Connecticut, 06511
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Ph.1, Open-Label, Dose Escalation & Expansion for Safety, Tolerability, PK, & Anti-Tumor Activity of STP707 Administered IV in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy.
An open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
Read the detailed description
A phase 1, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
The primary objective of this study is to determine the MTD or RP2D of STP707 and to establish the dose of STP707 recommended for future phase 2 studies administered intravenously.
A total of 30 subjects will be enrolled in dose escalation. Once MTD or RP2D has been established, up to 10 additional subjects will enrolled to confirm safety and explore anti-tumor activity.
Up to 5 dose levels will be explored (3,6,12,24,48 mg dose levels). Intermediate doses between scheduled dose levels maybe explored during escalation. A cycle is 28 days.
Dose escalation will follow a standard 3+3 design.
- Conditions
- Solid Tumor
- Being tested
- STP707
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP707Drug
Also called STP707 Powder for Injection
STP707 Powder for Injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Arm A | Experimental | Cohort 1: STP707 3 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. Receives: Drug: STP707 |
| Part 1: Arm B | Experimental | Cohort 2: STP707 6 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. Receives: Drug: STP707 |
| Part 1: Arm C | Experimental | Cohort 3: STP707 12 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. Receives: Drug: STP707 |
| Part 1: Arm D | Experimental | Cohort 4: STP707 24 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. Receives: Drug: STP707 |
| Part 1: Arm E | Experimental | Cohort A: STP707 36 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. Receives: Drug: STP707 |
| Part 1: Arm F | Experimental | Cohort 5: STP707 48 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. Receives: Drug: STP707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Recommended starting dose \& schedule
Measured: 28 Day Cycle
Limited Dose Toxicity (LDT)
Recommended starting dose \& dose escalation
Measured: 28 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Nov 2021
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- One subject will be enrolled at dose level 1. After the first subject has passed the DLT period, defined as 28 days, the second and third subject will be enrolled at least 24 hours apart. If more than 3 subjects have been identified for a given dose level, additional subjects may be enrolled in a lower dose level that has passed the DLT period up to a maximum of 12 subjects per dose level for dose levels 3 and 4 and up to a maximum of 9 subjects for dose levels A and 5. Subjects enrolled to backfill cohorts may be enrolled simultaneously, without a waiting period between subjects.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirnaomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrae Vandross, MD, Principal investigator, NEXT OncologyJason Henry, MD, Principal investigator, Sarah Cannon Research Institute at HealthONEAnthony El-Khoueiry, MD, Principal investigator, University of Southern CaliforniaAngela Alistar, MD, Principal investigator, Atlantic Health SystemHani Babiker, MD, Principal investigator, Mayo ClinicMichael Cecchini, MD, Principal investigator, Yale UniversityConor Steuer, MD, Principal investigator, Emory UniversityChristina Wu, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037149
- Sponsor's protocol ID
- SRN-707-001
- Status last verified
- Jul 2026
- First submitted
- 31 Aug 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph.1, Open-Label, Dose Escalation & Expansion for Safety, Tolerability, PK, & Anti-Tumor Activity of STP707 Administered IV in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy.
- ClinicalTrials.gov ID
- NCT05037149
- Acronym / sponsor ID
- SRN-707-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 8 Sep 2021 (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.
An open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
Detailed description
A phase 1, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, and anti-tumor activity of STP707 with IV administration in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
The primary objective of this study is to determine the MTD or RP2D of STP707 and to establish the dose of STP707 recommended for future phase 2 studies administered intravenously.
A total of 30 subjects will be enrolled in dose escalation. Once MTD or RP2D has been established, up to 10 additional subjects will enrolled to confirm safety and explore anti-tumor activity.
Up to 5 dose levels will be explored (3,6,12,24,48 mg dose levels). Intermediate doses between scheduled dose levels maybe explored during escalation. A cycle is 28 days.
Dose escalation will follow a standard 3+3 design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- One subject will be enrolled at dose level 1. After the first subject has passed the DLT period, defined as 28 days, the second and third subject will be enrolled at least 24 hours apart. If more than 3 subjects have been identified for a given dose level, additional subjects may be enrolled in a lower dose level that has passed the DLT period up to a maximum of 12 subjects per dose level for dose levels 3 and 4 and up to a maximum of 9 subjects for dose levels A and 5. Subjects enrolled to backfill cohorts may be enrolled simultaneously, without a waiting period between subjects.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Arm A | Experimental | Drug: STP707Cohort 1: STP707 3 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. |
| Part 1: Arm B | Experimental | Drug: STP707Cohort 2: STP707 6 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. |
| Part 1: Arm C | Experimental | Drug: STP707Cohort 3: STP707 12 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. |
| Part 1: Arm D | Experimental | Drug: STP707Cohort 4: STP707 24 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. |
| Part 1: Arm E | Experimental | Drug: STP707Cohort A: STP707 36 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. |
| Part 1: Arm F | Experimental | Drug: STP707Cohort 5: STP707 48 mg dose IV infusion, administered on D1,D8,D15,D22 of a 28-Day cycle. If the patient is deriving clinical benefit from the agent it maybe continued and administered on D1,D8, D15 and D22 for each successive cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subjects with histologically or cytologically confirmed advanced / metastatic or surgically unresectable solid tumors whose tumors are refractory to standard therapy
- Measurable disease per RECIST v 1.1 (primary or metastatic disease)
- ECOG performance status 0 - 1
- Life expectancy of at least 3 months
- Age ≥18 years
Key exclusion criteria (10 listed)
- Baseline Q-T corrected interval (QTc) interval of > 470 msec for all subjects calculated using Fridericia's formula
- New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
- Known active, uncontrolled infection with HIV or hepatitis B; subjects with hepatitis B allowed if on anti-viral therapy and have a viral load ≤ 500 IU; patients with a history of HIV must be on antiretroviral therapy for at least four weeks and have an HIV viral load ≤ 400 copies/mL, have CD4+ T cell counts ≥ 350 cells/uL and no history of AIDS-defining opportunistic infections within 3 months prior to treatment
- Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure, during the course of the study. (Note: Placement of a central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure.)
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
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 |
|---|---|---|
| STP707Also: STP707 Powder for InjectionSTP707 Powder for Injection | Drug | Part 1: Arm A, Part 1: Arm B, Part 1: Arm C, Part 1: Arm D, Part 1: Arm E, Part 1: Arm F |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 28 Day Cycle
Recommended starting dose \& schedule
Limited Dose Toxicity (LDT)
Time frame: 28 day cycle
Recommended starting dose \& dose escalation
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 29 Jul 2026.
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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.
Andrae Vandross, MD principal investigator
NEXT Oncology
Jason Henry, MD principal investigator
Sarah Cannon Research Institute at HealthONE
Anthony El-Khoueiry, MD principal investigator
University of Southern California
9 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 STP707 in people with Solid Tumor, run by Sirnaomics at 9 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 21 inclusion and 10 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Maximum Tolerated Dose (MTD) (time frame: 28 Day Cycle). The study lists 2 primary outcomes in all. 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 29 Jul 2026.