Find a Clinical Trial

Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors

This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.

Purpose of Study

This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.

The study will determine an MTD and RP2D using a conventional 3+3 study design with dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.

The schedule of STI-6643 administration will be weekly for the initial 4 weeks of a 5-week cycle and then every 2 weeks thereafter (i.e., starting with Cycle 2) of a 4-week cycle. Subjects will continue to receive STI-6643 in the absence of progression or unacceptable toxicity. Subjects with minimal toxicity will have the option of decreasing the frequency of their clinic visits during later cycles.

Eligibility

Age:
18 +
Sex:
All

Key Inclusion / Exclusion Criteria

Inclusion Criteria:

ECOG Performance Status <= 2 Histologically cytologically confirmed solid tumor Relapsed, is refractory to, or intolerant of standard of care therapy No available approved therapy that may provide clinical benefit per Investigator Measurable or evaluable disease by RECISTv1.14 Life expectancy of > 12 weeks per Investigator
Willingness to comply with the study schedule and all study requirements

Key Exclusion

Exclusion Criteria:

Participating in any other interventional clinical study
Previous exposure to an anti-CD47 or SIRPα antibody
≤ 28 days (or 5 half-lives if shorter) between of systemic anti-tumor treatment (e.g., chemotherapy, endocrine therapy, immunotherapy, cellular therapy) and C1D1
≤ 28 days from prior irradiation (≤ 7 days from limited field irradiation for control of symptoms) and C1D1
Known central nervous system (CNS) involvement with tumor (e.g., metastases, meningeal carcinomatosis)
Active second malignancy requiring ongoing systemic treatment
History of primary immunodeficiency disorders
History of active pulmonary tuberculosis

Conditions:

Cancer

Status:

Recruiting

Phase:

Phase 1

Study ID

NCT04900519

Read Detailed Summary

Start Date / End Date:

18/11/2021 -

Enrollment:

24

Full Details:

https://clinicaltrials.gov/ct2/show/NCT04900519

SELECT post_id, meta_key, meta_value FROM wp_postmeta WHERE post_id IN (5291,5287,5288,5289,5290) ORDER BY meta_id ASC /* From [sorrentotherapeutics.com/study/study-of-the-safety-and-efficacy-of-sti-6643-in-subjects-with-advanced-solid-tumors/] in [/nas/content/live/jshi/wp-content/themes/sorrento/single-study.php:255] */

5 Study Locations

United States

Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States


email: carrie.friedman@usoncology.com


University of California, San Diego
San Diego, California, 92093
United States


Sanford Health
Sioux Falls, South Dakota, 57104
United States


NEXT Oncology – Austin
Austin, Texas, 78758
United States


email: cdeleon@nextoncology.com
phone: 210-580-9521


Mary Crowley Cancer Research
Dallas, Texas, 75230
United States


email: referral@marycrowley.org
phone: 972-566-3000


Study Locations Map: