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

NCT05037149 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: SRN-707-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  Recommended starting dose \& schedule

  28 Day Cycle

• Limited Dose Toxicity (LDT)

  Recommended starting dose \& dose escalation

  28 day cycle

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: STP707

Interventions

STP707 DRUG

STP707 Powder for Injection

Also known as: STP707 Powder for Injection

Part 1: Arm A; Part 1: Arm B; Part 1: Arm C; Part 1: Arm D; Part 1: Arm E; Part 1: Arm F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Sirnaomics: lead

Study Sites (9)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

NEXT Oncology

Austin, Texas, 78758, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Andrae Vandross, MD

  NEXT Oncology

  PRINCIPAL INVESTIGATOR

• Jason Henry, MD

  Sarah Cannon Research Institute at HealthONE

  PRINCIPAL INVESTIGATOR

• Anthony El-Khoueiry, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Angela Alistar, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

• Hani Babiker, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Michael Cecchini, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Conor Steuer, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Christina Wu, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Zhaohui Jin, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: November 1, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (9)