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Monoclonal Antibodies

Sacituzumab Govitecan for Thymic Cancer

Phase 2
Recruiting
Led By Chul Kim, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Must not have
No concurrent therapy with approved or investigational anticancer therapeutics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see how sacituzumab govitecan-hziy affects adult patients with advanced thymoma and thymic carcinoma who have not responded to previous treatments. Patients will

Who is the study for?
This trial is for adults with advanced thymoma or thymic carcinoma who have already tried at least one treatment without success. Participants will receive ongoing cycles of a drug called Sacituzumab Govitecan, given through the vein once weekly on specific days, and will be monitored regularly.
What is being tested?
The trial tests Sacituzumab Govitecan's effectiveness in treating advanced thymoma and thymic carcinoma. The key measure is the overall response rate to this medication after previous treatments failed. Patients get fixed doses over continuous 21-day cycles until they can't tolerate it or their disease gets worse.
What are the potential side effects?
Potential side effects of Sacituzumab Govitecan include nausea, fatigue, hair loss, decreased blood cell counts leading to higher infection risk or bleeding problems, diarrhea, and allergic reactions during infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to either not have sex or use birth control, and not to donate sperm.
Select...
My hepatitis B is under control or I'm on treatment, and if I had hepatitis C, it's been treated.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with advanced thymoma or thymic carcinoma.
Select...
My blood and organ tests meet the required health standards.
Select...
My condition worsened after at least one treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not currently receiving any cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Duration of response (DOR)
Overall survival (OS)
Progression-free survival (PFS)

Side effects data

From 2020 Phase 3 trial • 529 Patients • NCT02574455
40%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SacituzumabExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
350 Previous Clinical Trials
139,147 Total Patients Enrolled
2 Trials studying Thymoma
53 Patients Enrolled for Thymoma
Gilead SciencesIndustry Sponsor
1,137 Previous Clinical Trials
867,965 Total Patients Enrolled
Chul Kim, MDPrincipal InvestigatorChul.Kim@gunet.georgetown.edu
4 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Thymoma
8 Patients Enrolled for Thymoma
~12 spots leftby Apr 2026
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