Open-Label Study for Safety, Tolerability, PK 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

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Brief Title

Safety, Tolerability, PK, Anti-Tumor Activity of STP705 Injected IT in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy

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

Brief 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 tumors who are refractory to standard
      therapy.

      Goals:

        1. To determine the MTD or RP2D of STP705 when administered intratumorally into
           cholangiocarcinoma, hepatocellular carcinoma, or liver metastasis.

        2. 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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum Tolerated Dose (MTD)


Condition

Hepatocellular Carcinoma

Intervention

STP705

Study Arms / Comparison Groups

 Cohort 1: STP705 20 μg dose
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

March 1, 2021

Completion Date

May 31, 2024

Primary Completion Date

March 1, 2024

Eligibility Criteria

        Inclusion Criteria:

          1. 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

          2. Measurable disease per RECIST v 1.1 (primary or metastatic disease)

          3. ECOG performance status or 0 - 1

          4. Life expectancy of at least 3 months

          5. Age ≥ 18 years

          6. Signed, written Institutional Review Board (IRB) approved informed consent

          7. A negative serum pregnancy test (for nonsterile women of child-bearing potential)

          8. Baseline Q-T corrected interval (QTc) interval of ≤ 480 msec using Frederica's formula

          9. 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

         10. Acceptable renal function, defined as:

             o Serum creatinine ≤ 1.5 ULN or Creatinine Clearance ≥ 30 mL/minute

         11. 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)

         12. Urinalysis with no clinically significant abnormalities

         13. Acceptable coagulation status with partial thromboplastin time (PTT) and International
             Normalized Ratio (INR) ≤1.5 times upper limit of normal

         14. Subject has adequate vitamin D level, as defined by serum total 25-Hydroxyvitamin D
             [25(OH)D] ≥ 20 to < 60 ng/mL

         15. 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)

         16. For men and women of child-producing potential, the use of effective contraceptive
             methods during the study

         17. 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

        Exclusion Criteria:

          1. 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

          2. 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

          3. Hepatocellular carcinoma patients with a Child Pugh score > B7

          4. Had paracentesis in the last 3 months; presence of ascites must be controlled by
             diuretics

          5. History of hepatic encephalopathy in the last 6 months

          6. History of variceal bleeding in the last 6 months

          7. Concomitant medications that are strong inhibitors or inducers of CYP450 enzymes that
             cannot be stopped or replaced during the study

          8. 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.)

          9. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
             therapy

         10. 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.

         11. Participation in a clinical study involving administration of an investigational
             compound within the past 30 days prior to study entry.

         12. Previous intratumoral injection within the past 30 days prior to study entry.

         13. Unwillingness or inability to comply with procedures required in this protocol

         14. Known allergy or hypersensitivity to the study drug(s) or one of the ingredients in
             the formulation

         15. 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nadia Sheibani, 301-740-1730, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04676633

Organization ID

SRN-705-005


Responsible Party

Sponsor

Study Sponsor

Sirnaomics

Collaborators

 Translational Drug Development

Study Sponsor

Nadia Sheibani, Study Director, Sirnaomics


Verification Date

May 2021