Hepatocellular CarcinomaPhase 1NCT04676633
Safety, Tolerability, PK, Anti-Tumor Activity of STP705 in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy
A Phase 1 study testing STP705 in people with Hepatocellular Carcinoma and Liver Metastases, run by Sirnaomics at 4 sites in United States.
Trial summary
This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis in subjects with advanced/metastatic or surgically unresectable solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Metastases, Cholangiocarcinoma
- What is being tested?
- STP705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2021to 13 Jan 2023
- 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 cholangiocarcinoma, hepatocellular carcinoma, or other solid malignancy with one or more qualifying liver metastases who are refractory to standard therapy
- Have at least one liver tumor or metastasis (≤ 5 cm in size) that is not sub-capsular and not near any major blood vessel
- Have no more than 7 liver lesions
- Is deemed safe for percutaneous intra-tumoral injection by local radiologist
- Measurable disease per RECIST v 1.1 (primary or metastatic disease)
- ECOG performance status or 0 - 1
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- Life expectancy of at least 3 months
- Age ≥ 18 years
- Signed, written Institutional Review Board (IRB) approved informed consent
- A negative serum pregnancy test (for nonsterile women of child-bearing potential)
- Baseline Q-T corrected interval (QTc) interval of ≤ 480 msec using Frederica's formula
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 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 ≥ 30 mL/minute
- Acceptable hematologic status:
- Hemoglobin ≥ 8 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 (≥ 65,000 if low platelet counts are due to splenic sequestration and portal hypertension)
- 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
- Subject has adequate vitamin D level, as defined by serum total 25-Hydroxyvitamin D [25(OH)D] ≥ 20 to < 60 ng/mL
- Completion of all previous treatments (including surgery, systemic chemotherapy and radiotherapy), as well as supportive care (including transfusion of blood, blood components and granulocyte colony-stimulation factor [G-CSF] treatment) at least 3 weeks before screening (6 weeks for nitrosoureas or mitomycin C), with no signs or symptoms of acute toxicity > Grade 1 (except alopecia)
- For men and women of child-producing potential, the use of effective contraceptive methods during the study
- No aspirin for ≥ 5 days in advance of intra-tumoral administration, as well as discontinuation of antiplatelet and anticoagulant medications for the appropriate amount of time
Who cannot join
- 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; patients 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
- Hepatocellular carcinoma patients with a Child Pugh score > B7
- Had paracentesis in the last 3 months; presence of ascites must be controlled by diuretics
- History of hepatic encephalopathy in the last 6 months
- History of variceal bleeding in the last 6 months
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- Concomitant medications that are strong inhibitors or inducers of CYP450 enzymes that cannot be stopped or replaced during the study
- 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.
- Participation in a clinical study involving administration of an investigational compound within the past 30 days prior to study entry.
- Previous intratumoral injection 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
- 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
4 sites in 1 country.
United States4 sites
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Norton Cancer Institute
Louisville, Kentucky, 40202
Atlantic Health System
Morristown, New Jersey, 07960
Honor Health
Scottsdale, Arizona, 85258
About this study
Official title: Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy
This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
Goals:
- To determine the MTD or RP2D of STP705 when administered intratumorally into cholangiocarcinoma, hepatocellular carcinoma, or liver metastasis.
- To establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.
Read the detailed description
This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of various doses of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis.
The primary objective of this study is to determine the MTD or RP2D of STP705 and to establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.
A total of up to 30 patients will be enrolled in the dose escalation phase of the study. In addition, once the MTD or recommended phase 2 dose has been established, up to 20 additional patients maybe enrolled to confirm safety and explore anti-tumor activity.
Up to five dose levels will be explored (20,40,80,160,320 μg dose levels) and will depend on the number and intensity of observed toxicity. Intermediate doses maybe explored during escalation period.
It will follow an accelerated titration design, enrolling 1 patient per dose cohort and will expand to a standard 3+3 design after.
In the accelearted titration a Grade 2 SE triggers the transition to the 3+3 part of the study. The 3+3 part of the study will start at dose level 160μg.
Subjects will be evaluated for DLTs in the first cycle of treatment and graded aacording to NCI CTCAE v5. A cycle is 28 days.
- Being tested
- STP705
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP705Drug
Also called STP705 POWDER FOR INJECTION
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: STP705 20 μg dose | Experimental | Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. Receives: Drug: STP705 |
| Cohort 2: STP705 40 μg dose | Experimental | Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. Receives: Drug: STP705 |
| Cohort 3: STP705 80 μg dose | Experimental | Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. Receives: Drug: STP705 |
| Cohort 4: STP705 160 μg dose | Experimental | Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. Receives: Drug: STP705 |
| Cohort 5: STP705 320 μg dose | Experimental | Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. Receives: Drug: STP705 |
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 (LTD)
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 posted21 Dec 2020
- Study start1 Mar 2021
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Accelerated titration design followed by expansion to standard 3+3 design
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirnaomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development
- Responsible party
- Sponsor
- Investigators
- Francois Lebel, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676633
- Sponsor's protocol ID
- SRN-705-005
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2020
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT04676633
- Acronym / sponsor ID
- SRN-705-005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 21 Dec 2020 (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.
This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy.
Goals:
- To determine the MTD or RP2D of STP705 when administered intratumorally into cholangiocarcinoma, hepatocellular carcinoma, or liver metastasis.
- To establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.
Detailed description
This is an open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of various doses of STP705 administered intratumorally in cholangiocarcinoma, hepatocellular carcinoma or liver metastasis.
The primary objective of this study is to determine the MTD or RP2D of STP705 and to establish the dose of STP705 recommended for future phase 2 studies when administered intratumorally.
A total of up to 30 patients will be enrolled in the dose escalation phase of the study. In addition, once the MTD or recommended phase 2 dose has been established, up to 20 additional patients maybe enrolled to confirm safety and explore anti-tumor activity.
Up to five dose levels will be explored (20,40,80,160,320 μg dose levels) and will depend on the number and intensity of observed toxicity. Intermediate doses maybe explored during escalation period.
It will follow an accelerated titration design, enrolling 1 patient per dose cohort and will expand to a standard 3+3 design after.
In the accelearted titration a Grade 2 SE triggers the transition to the 3+3 part of the study. The 3+3 part of the study will start at dose level 160μg.
Subjects will be evaluated for DLTs in the first cycle of treatment and graded aacording to NCI CTCAE v5. A cycle is 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Accelerated titration design followed by expansion to standard 3+3 design
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: STP705 20 μg dose | Experimental | Drug: STP705Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. |
| Cohort 2: STP705 40 μg dose | Experimental | Drug: STP705Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. |
| Cohort 3: STP705 80 μg dose | Experimental | Drug: STP705Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. |
| Cohort 4: STP705 160 μg dose | Experimental | Drug: STP705Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of each successive cycle. |
| Cohort 5: STP705 320 μg dose | Experimental | Drug: STP705Intratumoral injection, administered as a single agent on Day 1,8 and 15 of a 28-day cycle. If the patient is deriving clinical benefit from the agent it may be continued and will be administered on Day 1 of 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 (26 listed)
- Subjects with histologically or cytologically confirmed advanced/metastatic or surgically unresectable cholangiocarcinoma, hepatocellular carcinoma, or other solid malignancy with one or more qualifying liver metastases who are refractory to standard therapy
- Measurable disease per RECIST v 1.1 (primary or metastatic disease)
- ECOG performance status or 0 - 1
- Life expectancy of at least 3 months
- Age ≥ 18 years
Key exclusion criteria (15 listed)
- 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; patients 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
- Hepatocellular carcinoma patients with a Child Pugh score > B7
- Had paracentesis in the last 3 months; presence of ascites must be controlled by diuretics
- History of hepatic encephalopathy in the last 6 months
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 |
|---|---|---|
| STP705Also: STP705 POWDER FOR INJECTIONInvestigational Product | Drug | Cohort 1: STP705 20 μg dose, Cohort 2: STP705 40 μg dose, Cohort 3: STP705 80 μg dose, Cohort 4: STP705 160 μg dose, Cohort 5: STP705 320 μg dose |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 28 day cycle
Recommended starting dose \& schedule
Limited Dose Toxicity (LTD)
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 19 Mar 2024.
- 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.
Francois Lebel, MD study director
Chief Medical Officer
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 STP705 in people with Hepatocellular Carcinoma and Liver Metastases, run by Sirnaomics at 4 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 26 inclusion and 15 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 19 Mar 2024. 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 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 19 Mar 2024.