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

Active:	No
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT05037149
Trial Phases:	Phase I	Protocol IDs:	SRN-707-001 (primary) NCI-2022-02026
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Sirnaomics
NCI Full Details:	http://clinicaltrials.gov/show/NCT05037149

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.

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