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AMG 650 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Volastra Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing a new drug to see how safe and tolerable it is for adults, and to find the highest dose that is still safe.

Eligible Conditions

Advanced Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests

Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement

Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement

+4 more

Secondary outcome measures

Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650

Clinical Benefit Rate (CBR)

Duration of Response (DOR)

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Exploration PhaseExperimental Treatment1 Intervention

Participants will receive AMG 650 in 1 of 3 alternative schedules. The maximum tolerated dose (MTD) of each schedule will be estimated using isotonic regression (Ji et al, 2010). The Recommended Phase 2 Dose (RP2D) may be identified based on emerging safety, efficacy, and pharmacodynamics (PD) data prior to reaching an MTD.

Group II: Dose Expansion Phase Group 2: HGSOCExperimental Treatment1 Intervention

Participants with locally advanced or metastatic high grade serous ovarian cancer (HGSOC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.

Group III: Dose Expansion Phase Group 1: TNBCExperimental Treatment1 Intervention

Participants with locally advanced or metastatic triple negative breast cancer (TNBC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AMG 650

2020

Completed Phase 1

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Volastra Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

240 Total Patients Enrolled

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,622 Total Patients Enrolled

MDStudy DirectorAmgen

913 Previous Clinical Trials

924,085 Total Patients Enrolled

Frequently Asked Questions

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

Are there still vacancies available to participate in this experiment?

"Clinicaltrials.gov records indicate that this clinical trial has ceased recruitment of patients, having last been updated on December 1st 2022. Despite being inactive, there are still a wealth of trials actively enrolling participants: 2503 to be exact!"

Answered by AI

What is the current standing of AMG 650 with regards to US Food and Drug Administration authorization?

"The data surrounding AMG 650's safety is limited, so it has been rated a 1 on our scale of risk assessment. This indicates that this medication is presently in its first phase trial which allows for the evaluation of efficacy and safety."

Answered by AI

Who qualifies to take part in this scientific experiment?

"Patients should meet the criteria of having a solid tumor, advanced solid tumor, and be between 18 to 99 years old in order to join this medical experiment. 140 participants are being accepted for this study."

Answered by AI

Are individuals over 45 years old eligible for this research endeavor?

"This clinical trial is designed for patients that are between 18 and 99 years old. In total, there are 303 studies focusing on minors and 2317 trials targeting the elderly population."

Answered by AI

How many locations have authorized this experiment?

"At the current moment, this medical trial is signing up participants at 16 different centres. In addition to Houston, New york and Nashville there are 13 other places offering enrollment services. To reduce commute time consider selecting a clinic closest in proximity for yourself if you decide to join the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of AMG 650 in Adult Participants With Advanced Solid Tumors

2020. "Study of AMG 650 in Adult Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04293094.