Study of AMG 650 in Adult Participants With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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).

Key facts

Study ID

NCT04293094

Run by

Volastra Therapeutics, Inc.

People needed

66

Starts

2020-03-11

Expected to finish

2023-02-15

Last updated by the study team

2023-08-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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