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STI-6643 for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by Sorrento Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

[Females] If of child-bearing potential, must have a negative serum pregnancy test

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion at up to approximately 31 months

Awards & highlights

Study Summary

This trial is testing a new drug for people with cancer that has come back or didn't respond to other treatments. It's the first time this drug is being given to humans.

Who is the study for?

Adults with advanced solid tumors that have relapsed or are unresponsive to standard treatments can join this trial. They must have a life expectancy over 12 weeks, acceptable blood counts and organ function, and no recent other treatments or surgeries. Women of childbearing potential need a negative pregnancy test and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing STI-6643, an experimental drug given by IV for those with certain advanced cancers. It's the first time humans will receive it (phase 1), focusing on finding a safe dose while observing its effectiveness against tumors.See study design

What are the potential side effects?

Since this is a first-in-human study, specific side effects of STI-6643 are not yet known but may include typical reactions related to cancer drugs such as fatigue, nausea, immune system effects, infusion-related reactions and potential impacts on blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman who can have children and have a negative pregnancy test.

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I am 18 years old or older.

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I am a man who is either surgically sterile or will use contraception during and 30 days after the study.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer was confirmed through tissue or cell testing.

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I agree not to donate sperm during and for 30 days after the study.

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My condition did not improve with standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion at up to approximately 31 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion at up to approximately 31 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion at up to approximately 31 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of STI-6643

Secondary outcome measures

Anti-drug antibodies directed to STI-6643

Duration of response

Overall response rate

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: STI-6643Experimental Treatment1 Intervention

STI-6643 will be provided in a single use 10-mL high borosilicate type 1 glass vial at a concentration of 500mg/10 mL (50 mg/mL) administered intravenously weekly for 4 weeks, then biweekly for Cycles 2 and up.

0 / 7Eligibility criteria met

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Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor

47 Previous Clinical Trials

1,864 Total Patients Enrolled

Mike Royal, MDStudy DirectorSorrento Therapeutics, Inc.

27 Previous Clinical Trials

1,395 Total Patients Enrolled

Media Library

STI-6643 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04900519 — Phase 1

Solid Tumors Research Study Groups: STI-6643

Solid Tumors Clinical Trial 2023: STI-6643 Highlights & Side Effects. Trial Name: NCT04900519 — Phase 1

STI-6643 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04900519 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment presently recruiting participants?

"Affirmative. Clinicaltrials.gov lists this trial as actively recruiting, having first been posted on November 24th 2021 and last updated on November 3rd 2022. The study is seeking to include 100 patients from 4 different medical facilities."

Answered by AI

Are there any US-based sites conducting this research?

"Currently, the trial is running at 4 locations: San Diego, Dallas and Sioux Falls as well as one other location. It is recommended that you choose the closest of these sites to minimize travel requirements should you decide to partake in this study."

Answered by AI

How many participants are eligible to join this research venture?

"Affirmative. The clinicaltrials.gov website suggests that this trial is still open for enrolment, commencing on November 24th 2021 and most recently updated on the 3rd of November 2022. This investigation requires 100 participants to join from 4 different sites."

Answered by AI

Has STI-6643 received regulatory clearance from the Food and Drug Administration?

"The safety profile of STI-6643 is assessed as a 1, which reflects the limited amount of data available on its efficacy and safety due to it still being in Phase 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04900519.