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CAR T-cell Therapy

AMG 340 for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Teneobio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment for men with prostate cancer that has spread and no longer responds to hormone therapy or other treatments. The goal is to find the best dose of the new treatment, which will be given alone (monotherapy). The study will first test the treatment in a small group of people to see if it is safe and what side effects it causes (dose escalation), and then in a larger group of people (dose expansion).

Who is the study for?
This trial is for individuals with metastatic castrate-resistant prostate cancer who have tried at least two systemic therapies. Participants must have a stable condition, including controlled HIV or hepatitis if present, and good heart, liver, bone marrow, and kidney function. Those with neuroendocrine differentiation in their cancer or other recent malignancies are excluded.Check my eligibility
What is being tested?
AMG 340 is being tested in this phase 1 trial to assess its safety and effectiveness. The study has two parts: dose escalation to find the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), followed by a dose expansion to further evaluate the chosen dose's safety and pharmacokinetics.See study design
What are the potential side effects?
As AMG 340 is an investigational drug targeting T-cells in prostate cancer treatment, potential side effects may include immune system reactions, infusion-related responses, fatigue, organ inflammation but specific side effects will be determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I have had at least 2 treatments for metastatic prostate cancer and my cancer has gotten worse.
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I have been diagnosed with prostate cancer.
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My heart, liver, kidneys, and blood are all functioning well.
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I have HIV, HBV, or HCV but it's under control or cured.
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I have undergone chemical or surgical castration.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Area under the concentration-time curve within a dosing interval (AUC0-t) of AMG 340
Maximum Observed Plasma Concentration of AMG 340
Number of subjects with Dose-limiting toxicities (DLT)
+2 more
Secondary outcome measures
Anti-tumor activity by duration of objective response (DOR)
Anti-tumor activity by objective response rate (ORR)
Anti-tumor activity by progression free survival (PFS)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.
Group II: Dose EscalationExperimental Treatment1 Intervention
Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.

Find a Location

Who is running the clinical trial?

Teneobio, Inc.Lead Sponsor
3 Previous Clinical Trials
336 Total Patients Enrolled
AmgenLead Sponsor
1,354 Previous Clinical Trials
1,383,044 Total Patients Enrolled
13 Trials studying Prostate Cancer
4,844 Patients Enrolled for Prostate Cancer
Ben Buelow, MD, PhDStudy ChairTeneobio, Inc.
3 Previous Clinical Trials
416 Total Patients Enrolled

Media Library

AMG 340 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04740034 — Phase 1
Prostate Cancer Research Study Groups: Dose Escalation, Dose Expansion
Prostate Cancer Clinical Trial 2023: AMG 340 Highlights & Side Effects. Trial Name: NCT04740034 — Phase 1
AMG 340 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04740034 — Phase 1

Frequently Asked Questions

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

How many participants are currently registered for this clinical trial?

"The sponsor, Teneobio Inc., needs to recruit 130 participants who meet the study's enrollment criteria. These patients will be sourced from UCSF in San Francisco and Florida Cancer Specialists located in Sarasota."

Answered by AI

To what extent could TNB-585 endanger individuals?

"Based on the available evidence, TNB-585's safety is rated as a 1 since this is an early phase clinical trial. As such, there are limited data to support its efficacy and security."

Answered by AI

Are there a variety of establishments facilitating this medical experiment in the urban area?

"Currently, there are 7 sites running this trial. These include UCSF in San Francisco, Florida Cancer Specialists in Sarasota, and Tulane Cancer Center in New Orleans among a few others."

Answered by AI

Are there any vacancies left for this medical experiment?

"Yes, the trial is still open for enrolment. Its first posting was on April 29th 2021 and its details were last edited on July 14th 2022 per clinicaltrials.gov records."

Answered by AI
~15 spots leftby Sep 2024