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Monoclonal Antibodies

STP707 for Solid Tumors

Phase 1

Waitlist Available

Led By Zhaohui Jin, MD

Research Sponsored by Sirnaomics

Eligibility Criteria Checklist

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

Must have

Age ≥18 years

Subjects with histologically or cytologically confirmed advanced/metastatic or surgically unresectable solid tumors refractory to standard therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 day cycle

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective against solid tumors that are resistant to standard treatments.

Who is the study for?

Adults with advanced solid tumors not responding to standard treatments can join. They must have a life expectancy of at least 3 months, stable organ function, and no major health issues like severe heart disease or uncontrolled infections. Participants need an ECOG score of 0-1 (fully active or restricted in physically strenuous activity), acceptable blood counts, and use effective contraception.Check my eligibility

What is being tested?

The trial is testing STP707's safety and how well it works against solid tumors when given through IV. It's an open-label study where everyone gets the drug; first in escalating doses to find the safest dose, then expanding to more patients to further assess its effects on tumor growth.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, changes in liver or kidney function tests, alterations in blood counts which could lead to increased risk of infection or bleeding, fatigue, and other symptoms that will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer is advanced, cannot be removed by surgery, and does not respond to standard treatments.

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My liver is functioning within the required limits for the trial.

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I am fully active or can carry out light work.

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My kidney function is within the normal range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 day cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 day cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 day cycle for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Limited Dose Toxicity (LDT)

Maximum Tolerated Dose (MTD)

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 1: Arm FExperimental Treatment1 Intervention

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.

Group II: Part 1: Arm EExperimental Treatment1 Intervention

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.

Group III: Part 1: Arm DExperimental Treatment1 Intervention

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.

Group IV: Part 1: Arm CExperimental Treatment1 Intervention

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.

Group V: Part 1: Arm BExperimental Treatment1 Intervention

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.

Group VI: Part 1: Arm AExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

STP707

2022

Completed Phase 1

~20

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SirnaomicsLead Sponsor

11 Previous Clinical Trials

287 Total Patients Enrolled

Zhaohui Jin, MDPrincipal InvestigatorMayo Clinic

Conor Steuer, MDPrincipal InvestigatorEmory University

2 Previous Clinical Trials

119 Total Patients Enrolled

Media Library

STP707 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05037149 — Phase 1

Solid Tumors Research Study Groups: Part 1: Arm F, Part 1: Arm E, Part 1: Arm A, Part 1: Arm B, Part 1: Arm C, Part 1: Arm D

Solid Tumors Clinical Trial 2023: STP707 Highlights & Side Effects. Trial Name: NCT05037149 — Phase 1

STP707 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05037149 — Phase 1

Frequently Asked Questions

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

In what areas can one access this research endeavor?

"Patients can currently enroll in this trial at Sarah Cannon Research Institute at HealthONE located in Denver, Colorado; USC Norris Comprehensive Cancer Center situated in Los Angeles, California; NEXT Oncology based out of Austin, Texas and various other sites."

Answered by AI

Is enrollment for this research endeavor still ongoing?

"Affirmative, the contents accessible on clinicaltrials.gov affirm that this medical experiment is actively recruiting participants. It was initially published on November 1st 2021 and most recently changed on October 24th 2022; 40 patients are required from 4 different sites."

Answered by AI

What potential risks or side effects should patients be aware of when taking STP707?

"Due to the limited data available, STP707's safety was assessed as 1 on our scale of one to three. This is a Phase 1 trial which implies that research into efficacy and safety has yet to be conducted."

Answered by AI

What is the sample size of individuals participating in this research?

"Sirnaomics, the trial sponsor, is recruiting 40 suitable participants for this research study. Notably, Sarah Cannon Research Institute at HealthONE in Denver and USC Norris Comprehensive Cancer Center in Los Angeles will be two of the sites running trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Ph. 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05037149.