Clinical Trials /

Study of AMG 650 in Adult Participants With Advanced Solid Tumors

NCT04293094

Description:

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).

Related Conditions:
  • Breast Carcinoma
  • Endometrial Serous Adenocarcinoma
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Malignant Solid Tumor
  • Primary Peritoneal Serous Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of AMG 650 in Adult Participants With Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 20190131
  • NCT ID: NCT04293094

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
AMG 650Dose Expansion Phase Group 1: TNBC

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Dose Exploration PhaseExperimentalThe maximum tolerated dose (MTD) 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.
  • 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.
  • 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.
  • AMG 650

Eligibility Criteria

        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 or intolerant of existing therapy(ies) known to provide clinical benefit for
             their condition. 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. 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.

        Exclusion Criteria:

          -  Active brain metastases.

          -  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.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:Up to 12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Progression-free Survival (PFS)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Clinical Benefit Rate (CBR)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Time to Response (TTR)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Time to Progression (TTP)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Maximum Plasma Concentration (Cmax) of AMG 650
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Time to Maximum Plasma Concentration (Tmax) of AMG 650
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650
Time Frame:Up to 24 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Trial 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)

Last Updated

March 15, 2021