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AMB-05X Injections for Giant Cell Tumor

Phase 2

Recruiting

Research Sponsored by AmMax Bio, Inc.

Eligibility Criteria Checklist

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

Must have

Subject must be ≥ 18 years old

Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part 1 week 24 and part 2 week 72

Awards & highlights

Study Summary

This trial studies a drug to treat a rare adult cancer, over 24 weeks with possible follow-up for up to 2 years.

Who is the study for?

Adults over 18 with a type of tumor called TGCT in only one joint, measurable disease, and stable pain medication can join. They must have good blood, liver, and kidney function and agree to use contraception. People with extensive joint surgery history, other cancers needing treatment recently, serious illnesses or infections, MRI contraindications like pacemakers or certain metal implants cannot participate.Check my eligibility

What is being tested?

The trial is testing AMB-05X injections for treating TGCT. It's an open-label study where everyone gets the drug. The first part lasts 24 weeks to find the right dose; then there's a long-term extension phase where effects are monitored over several cycles each lasting 12 weeks.See study design

What are the potential side effects?

Specific side effects aren't listed here but generally could include reactions at the injection site, potential allergic responses to ingredients in AMB-05X, as well as any impacts on organ functions that will be closely monitored throughout the trial.

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 can be seen on scans and causes symptoms.

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My condition involves only one joint.

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I am capable of becoming pregnant and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part 1 week 24 and part 2 week 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 1 week 24 and part 2 week 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1 week 24 and part 2 week 72 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective Response Rate for Part 1

Treatment-emergent adverse events

Secondary outcome measures

Decrease of at least 30% in mean Brief Pain Inventory from Baseline

Duration of Response

EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Assessment

+13 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: AMB-05XExperimental Treatment1 Intervention

Subjects will receive an injection of AMB-05X once every 4 weeks for 24 weeks (for 6 treatments total). Based on ongoing review of the available safety, PK, PD, and efficacy data, the Sponsor may either increase or decrease the dose.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmMax Bio, Inc.Lead Sponsor

5 Previous Clinical Trials

157 Total Patients Enrolled

Dorothy Nguyen, MDStudy ChairAmMax Bio

5 Previous Clinical Trials

553 Total Patients Enrolled

Media Library

AMB-05X (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05349643 — Phase 2

Pigmented Villonodular Synovitis Research Study Groups: AMB-05X

Pigmented Villonodular Synovitis Clinical Trial 2023: AMB-05X Highlights & Side Effects. Trial Name: NCT05349643 — Phase 2

AMB-05X (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05349643 — Phase 2

Frequently Asked Questions

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

How many healthcare facilities are carrying out this clinical trial?

"This trial is currently running in 6 different sites, scattered among Miami, Houston and Woolloongabba. To reduce any travelling constraints posed by your participation, we recommend selecting a clinic nearest to you."

Answered by AI

How many participants have been recruited for this research endeavor?

"Indeed, according to clinicaltrials.gov, this medical trial commenced on the 26th of January 2023 and was most recently amended on the 5th of July 2023. The ongoing recruitment process is looking for 48 patients split across 6 sites."

Answered by AI

What are the core aims of this clinical trial?

"According to the trial sponsor, AmMax Bio Inc., the primary metric of success will be Treatment-emergent adverse events over a 24 Week period. Secondary measurements include Tumor response based on RECIST protocol; Objective Response Rate (ORR) as determined by central radiology review; and ORR for re-treated subjects also according to modified RECIST criteria."

Answered by AI

Has the AMB-05X drug been given authorization by the Food and Drug Administration?

"Our evaluation of AMB-05X's safety resulted in a score of 2 as it is only currently undergoing Phase 2 trials and there are no data points confirming its efficacy."

Answered by AI

Does this clinical trial have any current openings for participation?

"Affirmative, the clinicaltrials.gov database demonstrates that this study is currently seeking participants. Initially posted on January 26th 2023 and most recently modified July 5th 2023; 48 patients need to be sourced from 6 distinct centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

2023. "A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05349643.