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CompletedNCT04293094Updated Aug 24, 2023

Study of AMG 650 in Adult Participants With Advanced Solid Tumors

A Phase 1 interventional study of AMG 650 in Advanced Solid Tumors, sponsored by Volastra Therapeutics, Inc.. Completed at 22 sites in 7 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by Volastra Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2022, 3 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Advanced Solid Tumors

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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)
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 66 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Volastra Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Dose Exploration Phase

    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.

    Drug: AMG 650

  • Experimental
    Dose Expansion Phase Group 1: TNBC

    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.

    Drug: AMG 650

  • Experimental
    Dose Expansion Phase Group 2: HGSOC

    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.

    Drug: AMG 650

Interventions

  • DrugAMG 650

    AMG 650 administered orally as a tablet.

06

What researchers measure

Primary outcomes

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

    Time frame: Up to 12 months

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

  4. Number of Participants with Treatment-related Adverse Events

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 24 months

  2. Duration of Response (DOR)

    Time frame: Up to 24 months

  3. Progression-free Survival (PFS)

    Time frame: Up to 24 months

  4. Clinical Benefit Rate (CBR)

    Time frame: Up to 24 months

  5. Time to Response (TTR)

    Time frame: Up to 24 months

  6. Time to Progression (TTP)

    Time frame: Up to 24 months

  7. Overall Survival (OS)

    Time frame: Up to 24 months

  8. Maximum Plasma Concentration (Cmax) of AMG 650

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

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

    Time frame: Up to 24 months

07

Study locations

22 sites
  • The Angeles Clinic and Research Institute, West Los Angeles Office
    Los Angeles, California 90025, United States
  • Sarcoma Oncology Research Center LLC
    Santa Monica, California 90403, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Washington University
    Saint Louis, Missouri 63110-1093, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Laura and Isaac Perlmutter Cancer Center at New York University Langone
    New York, New York 10016, United States
  • Wake Forest University School of Medicine
    Winston-Salem, North Carolina 27157, United States
  • Stephenson Cancer Center
    Oklahoma City, Oklahoma 73104, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Texas Oncology - Baylor
    Dallas, Texas 75246, United States
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • The Queen Elizabeth Hospital
    Woodville South, South Australia 5011, Australia
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3000, Australia
  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
    Leuven, 3000, Belgium
  • Cross Cancer Institute
    Edmonton, Alberta T6G 1Z2, Canada
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 1Z5, Canada
  • IRCCS Istituto Europeo di Oncologia
    Milano, 20141, Italy
  • Aichi Cancer Center
    Nagoya-shi, Aichi 464-8681, Japan
  • National Cancer Center Hospital East
    Kashiwa-shi, Chiba 277-8577, Japan
  • Hospital General Universitario Gregorio Marañon
    Madrid, 28009, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04293094
Lead sponsor
Volastra Therapeutics, Inc.
Collaborators
Amgen
Responsible party
Sponsor
First posted
Mar 3, 2020
Start date
Mar 11, 2020
Primary completion
Oct 24, 2022
Completion
Feb 15, 2023
Last update
Aug 24, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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