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A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors

ConditionsThymomaThymic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgetown University

About this trial

The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy.

The main question it aims to answer is:

• What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma?

Participants will:

* receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity * have regular blood tests, scans, and examinations to monitor their health. * have blood and a biopsy of their tumor for research purposes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >/= 18 years at time of signing informed consent form (ICF)

Ability to understand and the willingness to sign a written informed consent document

Patients with histologically confirmed advanced thymoma or thymic carcinoma

Patients who have experienced disease progression after treatment with at least one prior systemic therapy

Disqualifiers

Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the view of the investigator, contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.

Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.

Symptomatic brain metastasis requiring corticosteroids. Patients with treated brain metastases are eligible.

No concurrent therapy with approved or investigational anticancer therapeutics

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab govitecan-hziy

    Drug

    10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: SacituzumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Objective response is defined a confirmed overall response of complete response (CR) or partial response (PR) as assessed by RECIST v1.1. The objective response rate (ORR) will be estimated number of evaluable patients with a documented objective response divided by the total number of evaluable patients.

Time frame
1 year

Secondary outcomes

1

Duration of response (DOR)

DOR will be evaluated in evaluable patients who had a documented objective response. This is the time from the documented objective response, as assessed by RECIST v1.1, until disease progression or death, whichever occurs first. Patients who are alive without a documented disease progression will be censored at the time of their last disease evaluation.

Time frame
1 year
2

Progression-free survival (PFS)

Progression-free survival (PFS) is defined as the time from the time of treatment initiation until disease progression or death, whichever occurs first. Patients who are alive without a documented progression will be censored at the time of their last disease evaluation

Time frame
1 year
3

Overall survival (OS)

Overall survival (OS) is defined as the time of treatment initiation until death. Patients who are alive will be censored at the time of their last contact.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgetown University

Lead sponsor

Gilead Sciences

Collaborator

Source ClinicalTrials.gov
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