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Completed

NCT Number: NCT04293094

Study of AMG 650 in Adult Participants 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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Queen Elizabeth Hospital, Woodville South, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

AMG 650

Drug

AMG 650 administered orally as a tablet.

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

Sponsors and collaborators

Lead sponsor

Volastra Therapeutics, Inc.

Industry

Collaborators

  • Amgen

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 3, 2020
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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