CompletedPhase 1

Study of AMG 650 in Adult Participants With Advanced Solid Tumors

United States, Australia, Belgium66 participantsStarted 2020-03-11

Plain-language 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).

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 12 months

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

Timeframe: Up to 24 months

Number of Participants with Serious Adverse Events (SAEs)

Timeframe: Up to 24 months

Number of Participants with Treatment-related Adverse Events

Timeframe: Up to 24 months

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

Timeframe: Up to 24 months

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

Timeframe: Up to 24 months

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

Timeframe: Up to 24 months

Trial details

NCT IDNCT04293094

SponsorVolastra Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-24

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 12 months

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

Timeframe: Up to 24 months

Number of Participants with Serious Adverse Events (SAEs)

Timeframe: Up to 24 months

Number of Participants with Treatment-related Adverse Events

Timeframe: Up to 24 months

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

Timeframe: Up to 24 months

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

Timeframe: Up to 24 months

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

Timeframe: Up to 24 months