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Monoclonal Antibodies
Sacituzumab Govitecan for Metastatic Cancer (TROPiCS-03 Trial)
Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy. No more than 3 prior lines of systemic treatment is allowed
Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
TROPiCS-03 Trial Summary
This trial will test a new drug to see if it can shrink tumors in people with metastatic solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that have spread, who are relatively active and can perform daily activities. They must have measurable disease, adequate blood counts, liver and kidney function, a life expectancy of at least 3 months, and specific treatment histories depending on their cancer type.Check my eligibility
What is being tested?
The study is testing Sacituzumab Govitecan-hziy in participants with metastatic solid tumors to understand its effects better. It's given to those whose cancer has worsened despite previous treatments.See study design
What are the potential side effects?
Sacituzumab Govitecan may cause nausea, diarrhea, hair loss (alopecia), fatigue, neutropenia (low white blood cell count which can increase infection risk), anemia (low red blood cell count causing tiredness) and other potential side effects.
TROPiCS-03 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer worsened after treatments including platinum and anti-PD-(L)1 therapy, with no more than 3 treatments tried.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My small cell lung cancer has worsened after initial treatments including platinum and PD-(L)1 therapy.
Select...
My cancer can be measured on scans according to specific criteria.
Select...
My cancer is advanced and has spread to other parts of my body.
Select...
My head/neck cancer worsened after specific treatments, and I've had 3 or fewer treatments.
Select...
My NSCLC worsened after treatments with platinum and PD-(L)1 therapy.
TROPiCS-03 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
Secondary outcome measures
Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR
Clinical Benefit Rate (CBR) According to RECIST 1.1 by Investigator's Assessment
DOR According to RECIST 1.1 by Investigator's Assessment
+9 moreSide effects data
From 2020 Phase 3 trial • 529 Patients • NCT0257445540%
Fatigue
30%
Nausea
27%
Anaemia
25%
Neutropenia
23%
Constipation
21%
Decreased appetite
20%
Neutrophil count decreased
18%
Cough
18%
Dyspnoea
17%
Diarrhoea
16%
Alopecia
16%
Vomiting
13%
Hypokalaemia
13%
Headache
13%
Back pain
13%
Asthenia
12%
Pyrexia
12%
Aspartate aminotransferase increased
11%
Oedema peripheral
11%
Neuropathy peripheral
10%
Alanine aminotransferase increased
10%
White blood cell count decreased
8%
Urinary tract infection
8%
Myalgia
8%
Pain in extremity
7%
Platelet count decreased
7%
Arthralgia
7%
Dizziness
7%
Abdominal pain
7%
Weight decreased
6%
Mucosal inflammation
6%
Lymphocyte count decreased
6%
Bone pain
6%
Hypomagnesaemia
6%
Hypertension
6%
Thrombocytopenia
6%
Stomatitis
5%
Insomnia
5%
Pain
5%
Rash
5%
Blood alkaline phosphatase increased
5%
Hyperglycaemia
4%
Oropharyngeal pain
4%
Hypophosphataemia
4%
Anxiety
4%
Abdominal pain upper
4%
Breast pain
3%
Upper respiratory tract infection
3%
Musculoskeletal chest pain
3%
Dysgeusia
3%
Lymphoedema
3%
Pruritus
3%
Pleural effusion
3%
Gastrooesophageal reflux disease
3%
Chills
2%
Nasopharyngitis
2%
Hypocalcaemia
2%
Febrile neutropenia
2%
Sepsis
2%
Pneumonia
1%
Nasal congestion
1%
Dyspnoea exertional
1%
Dry skin
1%
Rash maculo-papular
1%
Pericardial effusion
1%
Pulmonary embolism
1%
Respiratory failure
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment of Physician's Choice (TPC)
Sacituzumab Govitecan
TROPiCS-03 Trial Design
1Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan-hziyExperimental Treatment1 Intervention
Participants with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), endometrial cancer, or metastatic small cell lung cancer (mSCLC) will receive sacituzumab govitecan-hziy 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy
2019
Completed Phase 3
~550
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,097 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,528 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.My small cell lung cancer has worsened after initial treatments including platinum and PD-(L)1 therapy.You are expected to live for at least 3 more months.My cancer can be measured on scans according to specific criteria.I have stable brain metastases, not on high steroids, and no carcinomatous meningitis.My blood counts are stable without needing transfusions or growth support recently.My endometrial cancer worsened after treatments including platinum and anti-PD-(L)1 therapy, with no more than 3 treatments tried.I have been treated with topoisomerase I inhibitors before.My cancer is advanced and has spread to other parts of my body.My head/neck cancer worsened after specific treatments, and I've had 3 or fewer treatments.My NSCLC worsened after treatments with platinum and PD-(L)1 therapy.I still have side effects from previous treatments that are not mild.I haven't had cancer treatment or radiation in the last 2-4 weeks.My liver and kidneys are functioning well.I have another type of cancer that is currently active.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan-hziy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available to join this research endeavor?
"As per the information from clinicaltrials.gov, this research initiative is recruiting participants at present. It was first announced on October 15th 2019 and its most recent update occurred on November 15th 2022."
Answered by AI
What other explorations have been made regarding the efficacy of Sacituzumab Govitecan-hziy?
"Presently, 5 studies for Sacituzumab Govitecan-hziy are in Phase 3 with 33 trials being conducted worldwide. While some of the investigations take place in Birmingham and Victoria, this medication is studied at a staggering 1,397 sites globally."
Answered by AI
Is this a groundbreaking or pioneering research endeavor?
"Since its initial research in 2018, sponsored by Hoffmann-La Roche, Sacituzumab Govitecan-hziy has undergone an extensive drug approval process. Nowadays there are 33 active studies occurring across 418 cities and 32 countries."
Answered by AI
How many participants can enroll in this research trial?
"This research is backed by Gilead Sciences, and requires 165 qualifying participants to be enrolled. The trial will occur at UCLA Hematology/Oncology in Los Angeles, Indiana as well as London Health Sciences Centre- Victoria Hospital in London, Ohio."
Answered by AI
Is Sacituzumab Govitecan-hziy a secure treatment for patients?
"Our team at Power has rated sacituzumab govitecan-hziy a 2, as this is still in the Phase 2 trial stage. Although there is some data that supports its safety, no evidence exists for its efficacy yet."
Answered by AI
To what extent is Sacituzumab Govitecan-hziy employed for medicinal purposes?
"Sacituzumab Govitecan-hziy is regularly employed as a therapeutic procedure. It has also been observed to be beneficial for the management of pharmacotherapy, uc 84572 and breast related issues."
Answered by AI
How many venues are currently managing this trial?
"UCLA Hematology/Oncology in Los Angeles, Indiana, London Health Sciences Centre- Victoria Hospital in London, Ohio, and PathGroup Labs LLC in Fort Wayne, Michigan are the main trial sites for this clinical study. Additionally there are 29 other locations participating."
Answered by AI
Who else is applying?
What site did they apply to?
Virginia Cancer Specialists, PC
What portion of applicants met pre-screening criteria?
Did not meet criteria
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