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

Status
Active
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05037149
Protocol IDs
SRN-707-001 (primary)
NCI-2022-02026
Study Sponsor
Sirnaomics

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.

Objectives

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.

Eligibility

  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:
  9. Bilirubin = 1.5 times upper limit of normal
  10. AST (SGOT), ALT (SGPT) = 5 times upper limit of normal because of cancer or metastases to the liver
  11. Acceptable renal function, defined as: o Serum creatinine = 1.5 ULN or Creatinine Clearance = 50 mL/minute
  12. Acceptable hematologic status:
  13. Hemoglobin = 9 g/dL (a transfusion is allowed if Hemoglobin stays stable thereafter)
  14. Absolute neutrophil count (ANC) = 1,000 cells/mm3
  15. Platelet count = 100,000 plt/mm3 x 109/ L
  16. Urinalysis with no clinically significant abnormalities
  17. 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
  18. 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
  19. Completion of all previous treatments (including surgery, systemic chemotherapy, and radiotherapy) at least 3 weeks before screening
  20. For men and women of child-producing potential, the use of effective contraceptive methods during the study
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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