Study of AMG 650 in Adult Participants With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT04293094
• Other study ID #: 20190131
• Status: Completed
• Phase: Phase 1
• Start date: March 11, 2020
• Est. completion date: February 15, 2023

Study information

• Verified date: August 2023
• Source: Volastra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 15, 2023
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• AMG 650
AMG 650 administered orally as a tablet.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Belgium	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Italy	IRCCS Istituto Europeo di Oncologia	Milano
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	Aichi Cancer Center	Nagoya-shi	Aichi
Spain	Hospital General Universitario Gregorio Marañon	Madrid
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Texas Oncology - Baylor	Dallas	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	The Angeles Clinic and Research Institute, West Los Angeles Office	Los Angeles	California
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Laura and Isaac Perlmutter Cancer Center at New York University Langone	New York	New York
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	Sarcoma Oncology Research Center LLC	Santa Monica	California
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Volastra Therapeutics, Inc.	Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Italy,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicities (DLTs)		Up to 12 months
Primary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Up to 24 months
Primary	Number of Participants with Serious Adverse Events (SAEs)		Up to 24 months
Primary	Number of Participants with Treatment-related Adverse Events		Up to 24 months
Primary	Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement		Up to 24 months
Primary	Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement		Up to 24 months
Primary	Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests		Up to 24 months
Secondary	Objective Response Rate (ORR)		Up to 24 months
Secondary	Duration of Response (DOR)		Up to 24 months
Secondary	Progression-free Survival (PFS)		Up to 24 months
Secondary	Clinical Benefit Rate (CBR)		Up to 24 months
Secondary	Time to Response (TTR)		Up to 24 months
Secondary	Time to Progression (TTP)		Up to 24 months
Secondary	Overall Survival (OS)		Up to 24 months
Secondary	Maximum Plasma Concentration (Cmax) of AMG 650		Up to 24 months
Secondary	Time to Maximum Plasma Concentration (Tmax) of AMG 650		Up to 24 months
Secondary	Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650		Up to 24 months