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Advanced Solid TumorsPhase 1NCT04293094

Study of AMG 650 in Adult Participants With Advanced Solid Tumors

A Phase 1 study testing AMG 650 in people with Advanced Solid Tumors, run by Volastra Therapeutics, Inc. at 22 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
AMG 650
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
22 sitesin 7 countries
Study dates
11 Mar 2020to 15 Feb 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female ≥ 18 years old
  • Triple Negative Breast Cancer participants only: Participant must have histologically or cytologically confirmed metastatic or locally recurrent estrogen receptor (ER)-negative (<1% by immunohistochemistry [IHC]), progesterone receptor (PR)-negative (<1% IHC) and human epidermal growth factor receptor 2 (Her2)-negative (either fluorescent in situ hybridisation [FISH] negative, 0 or 1+ by IHC, or IHC2+ and FISH negative per ASCO/CAP definition) breast cancer. Participant must be relapsed/refractory to at least one line of systemic chemotherapy in the metastatic setting (excluding neoadjuvant or adjuvant chemotherapies) or intolerant of existing therapy(ies) known to provide clinical benefit or have no other available treatment options. Prior exposure to an immune checkpoint inhibitor is allowed.
  • Platinum-Resistant High Grade Serous Ovarian Cancer, primary peritoneal cancer and/or fallopian-tube cancer participants only: Participant must have histologically or cytologically confirmed diagnosis of metastatic or unresectable high grade serous ovarian cancer, with platinum-resistance defined as progression during or within 6 months of a platinum-containing regimen, with no other treatment option available. Prior exposure to platinum-resistant recurrence therapy is allowed.
  • Serous Endometrial Cancer participants only (Dose Exploration only): Participant must have histologically or cytologically confirmed diagnosis of metastatic or recurrent serous endometrial cancer, and be relapsed/refractory to at least one line of systemic therapy in the metastatic/recurrent setting or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
  • Participants with advanced or metastatic solid tumor with TP53MUT (Dose Exploration only, as assessed by local testing) that is unresectable and relapsed/refractory to at least one line of systemic chemotherapy or intolerant.
  • TNBC participants only (Dose Expansion): Progressed on no more than 3 prior lines of systemic therapy for locally advanced or metastatic disease (not including adjuvant or neo-adjuvant). Systemic therapy with poly ADP ribose polymerase (PARP) inhibitor will be counted as one line of therapy.
  • HGSOC participants only (Dose Expansion): Progressed on no more than 5 prior lines of systemic therapy for locally advanced or metastatic disease (not including adjuvant or neo-adjuvant). Systemic therapy with (PARP) inhibitor will be counted as one line of therapy. Induction followed by maintenance will be counted as one line of therapy.

Who cannot join

  • Untreated or symptomatic brain metastases and leptomeningeal disease (exception: benign asymptomatic tumors are permitted).
  • Current primary CNS tumor, hematological malignancies or lymphoma.
  • Uncontrolled pleural effusions(s), pericardial effusion, or ascites.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Trial locations and contacts

22 sites in 7 countries.

22 sites in 7 countries

United States13 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Texas Oncology - Baylor

    Dallas, Texas, 75246

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • The Angeles Clinic and Research Institute, West Los Angeles Office

    Los Angeles, California, 90025

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Laura and Isaac Perlmutter Cancer Center at New York University Langone

    New York, New York, 10016

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sarcoma Oncology Research Center LLC

    Santa Monica, California, 90403

  • Washington University

    St Louis, Missouri, 63110-1093

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Australia2 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Canada2 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Japan2 sites

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

Other trials in Japan

Belgium1 site

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Italy1 site

  • IRCCS Istituto Europeo di Oncologia

    Milan, 20141

Other trials in Italy

Spain1 site

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

Other trials in Spain

About this study

Official title: A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors

To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Being tested
AMG 650
Keywords
AMG 650, Locally-advanced/metastatic solid tumors, p53 mutation, Serous like endometrial cancers, Triple negative breast cancer (TNBC), High grade serous ovarian cancer (HGSOC)
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 650Drug

    AMG 650 administered orally as a tablet.

Study groups in NCT04293094
Study groupRoleWhat they receive
Dose Exploration PhaseExperimentalParticipants 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.
Receives: Drug: AMG 650
Dose Expansion Phase Group 1: TNBCExperimentalParticipants 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.
Receives: Drug: AMG 650
Dose Expansion Phase Group 2: HGSOCExperimentalParticipants 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.
Receives: Drug: AMG 650

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose Limiting Toxicities (DLTs)

    Measured: Up to 12 months

  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to 24 months

  3. Number of Participants with Serious Adverse Events (SAEs)

    Measured: Up to 24 months

  4. Number of Participants with Treatment-related Adverse Events

    Measured: Up to 24 months

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

Secondary outcomes (10)

  1. Objective Response Rate (ORR)

    Measured: Up to 24 months

  2. Duration of Response (DOR)

    Measured: Up to 24 months

  3. Progression-free Survival (PFS)

    Measured: Up to 24 months

  4. Clinical Benefit Rate (CBR)

    Measured: Up to 24 months

  5. Time to Response (TTR)

    Measured: Up to 24 months

  6. Time to Progression (TTP)

    Measured: Up to 24 months

  7. Overall Survival (OS)

    Measured: Up to 24 months

  8. Maximum Plasma Concentration (Cmax) of AMG 650

    Measured: Up to 24 months

  9. Time to Maximum Plasma Concentration (Tmax) of AMG 650

    Measured: Up to 24 months

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

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start11 Mar 2020
  3. Primary completion24 Oct 2022
  4. Study completion15 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04293094
Sponsor's protocol ID
20190131
Status last verified
Aug 2023
First submitted
2 Mar 2020
Last updated
24 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 650 in people with Advanced Solid Tumors, run by Volastra Therapeutics, Inc. at 22 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Australia, Canada, Japan, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04293094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.

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