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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: STP707

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • California
    • Los Angeles, California, United States, 90033
      • Usc Norris Comprehensive Cancer Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Sarah Cannon Research Institute at HealthONE
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System
  • Texas
    • Austin, Texas, United States, 78758
      • NEXT Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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) ≤ 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 unless patient is on anticoagulants and has stable PTT and PT that are within normal therapeutic range for disease under management
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 vitamin D supplementation se per clinic dosing guidelines and may still be enrolled provided they are started on vitamin D supplementation
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / 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; STP707 Powder for Injection; Other Names: STP707 Powder for Injection
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; STP707 Powder for Injection; Other Names: STP707 Powder for Injection
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; STP707 Powder for Injection; Other Names: STP707 Powder for Injection
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; STP707 Powder for Injection; Other Names: STP707 Powder for Injection
Experimental: Part 1: Arm E; 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.	Drug: STP707; STP707 Powder for Injection; Other Names: STP707 Powder for Injection
Experimental: Part 1: Arm F; 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.	Drug: STP707; STP707 Powder for Injection; Other Names: STP707 Powder for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose (MTD)	Recommended starting dose & schedule	28 Day Cycle
Limited Dose Toxicity (LDT)	Recommended starting dose & dose escalation	28 day cycle

Collaborators and Investigators

• Sponsor: Sirnaomics
• Investigators: Principal Investigator: Anthony El-Khoueiry, MD, University of Southern California; Principal Investigator: Conor Steuer, MD, Emory University; Principal Investigator: Hani Babiker, MD, Mayo Clinic; Principal Investigator: Andrae Vandross, MD, NEXT Oncology; Principal Investigator: Jason Henry, MD, Sarah Cannon Research Institute at HealthONE; Principal Investigator: Angela Alistar, MD, Atlantic Health System; Principal Investigator: Michael Cecchini, MD, Yale University; Principal Investigator: Christina Wu, MD, Mayo Clinic; Principal Investigator: Zhaohui Jin, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SRN-707-001

Drug and device information, study documents

• 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