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Ph. 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Solid Tumors

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ClinicalTrials.gov Identifier: NCT05037149
Recruitment Status : Not yet recruiting
First Posted : September 8, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Sirnaomics

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: STP707 Phase 1

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.

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Study Type : Interventional
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 3+3 design dose escalation followed by
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Arm Intervention/treatment
Experimental: Part 1: Arm A
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.
Drug: STP707
Investigational Product

Experimental: Part 1: Arm B
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.
Drug: STP707
Investigational Product

Experimental: Part 1: Arm C
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.
Drug: STP707
Investigational Product

Experimental: Part 1: Arm D
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.
Drug: STP707
Investigational Product

Experimental: Part 1: Arm E
Cohort 4: 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.
Drug: STP707
Investigational Product




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 28 Day Cycle ]
    Recommended starting dose & schedule

  2. Limited Dose Toxicity (LDT) [ Time Frame: 28 day cycle ]
    Recommended starting dose & dose escalation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with histologically or cytologically confirmed advanced / metastatic or surgically unresectable solid tumors whose tumors are refractory to standard therapy
  2. Measurable disease per RECIST v 1.1 (primary or metastatic disease)
  3. ECOG performance status 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. 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
  9. Acceptable renal function, defined as:

    o Serum creatinine ≤ 1.5 ULN or Creatinine Clearance ≥ 50 mL/minute

  10. 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
  11. Urinalysis with no clinically significant abnormalities
  12. Acceptable coagulation status with partial thromboplastin time (PTT) and International Normalized Ratio (INR) ≤ 1.5 times upper limit of normal.
  13. 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 Vit D supplementation during screening and be retested during the screening period
  14. Completion of all previous treatments (including surgery, systemic chemotherapy, and radiotherapy) at least 3 weeks before screening
  15. For men and women of child-producing potential, the use of effective contraceptive methods during the study

Exclusion Criteria:

  1. Baseline Q-T corrected interval (QTc) interval of > 470 msec for all subjects calculated using Fridericia's formula
  2. 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
  3. 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
  4. 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.)
  5. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  6. 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.
  7. Participation in a clinical study involving administration of an investigational compound within the past 30 days prior to study entry.
  8. Unwillingness or inability to comply with procedures required in this protocol
  9. Known allergy or hypersensitivity to the study drug(s) or one of the ingredients in the formulation (e.g., Trehalose dihydrate)
  10. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037149


Contacts
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Contact: nadia Sheibani 13057401730 nadiasheibani@sirnaomics.com
Contact: Nadia Sheibani nadiasheibani@sirnaomics.com

Sponsors and Collaborators
Sirnaomics
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Responsible Party: Sirnaomics
ClinicalTrials.gov Identifier: NCT05037149    
Other Study ID Numbers: SRN-707-001
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms