Sacituzumab Govitecan for Thymic Cancer

Recruiting at 3 trial locations

Overseen By Chul Kim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Georgetown University

Must not be taking: Anticancer therapeutics

Disqualifiers: Pregnancy, Breastfeeding, Brain metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Until disease progression or unacceptable toxicity

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called sacituzumab govitecan for individuals with advanced thymoma or thymic carcinoma. Researchers aim to evaluate the drug's effectiveness after patients have tried at least one other unsuccessful treatment. Participants will receive the drug through an IV on a regular schedule and undergo check-ups, including blood tests and scans, to monitor their health. Those with advanced thymic cancer whose disease has worsened after previous treatments might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you cannot have concurrent therapy with other approved or investigational anticancer treatments. It's best to discuss your current medications with the trial team to get a clear answer.

Is there any evidence suggesting that sacituzumab govitecan is likely to be safe for humans?

Research shows that sacituzumab govitecan-hziy, the treatment under study in this trial, has undergone safety testing in several cancer types. Studies have found it to be generally well-tolerated by patients. For instance, in trials involving breast and bladder cancer, many patients continued the treatment without severe side effects.

Common side effects include nausea, diarrhea, and tiredness, typical of many cancer treatments. Notably, the FDA has already approved this treatment for other cancers, indicating a good safety record. However, as with any treatment, some patients might experience more serious side effects, so careful monitoring remains important.

Participants in this trial will receive regular check-ups, including blood tests and scans, to ensure their safety during treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for thymic cancer?

Sacituzumab govitecan is unique because it combines an antibody targeting a protein commonly found in thymic cancer cells with a chemotherapy drug. This approach allows the treatment to deliver chemotherapy directly to the cancer cells, potentially reducing harm to healthy cells. Researchers are excited because this targeted delivery method could lead to more effective treatment with fewer side effects compared to standard chemotherapy options like cisplatin or etoposide. Additionally, sacituzumab govitecan has shown promise in treating other cancers, which adds to the hope that it could be a game-changer for thymic cancer patients.

What evidence suggests that sacituzumab govitecan might be an effective treatment for thymic cancer?

Research has shown that sacituzumab govitecan, a targeted cancer treatment, effectively treats various tumors, including breast and bladder cancers. In these cases, many patients saw their tumors shrink or disappear. Although less data exists for thymoma and thymic carcinoma, the treatment's mechanism suggests promise. In this trial, participants will receive sacituzumab govitecan, which targets cancer cells by delivering chemotherapy directly to them, potentially reducing tumor growth in thymic cancers. Early results in other cancers suggest it might work well here too. ^{1 2 3 5 6}

Who Is on the Research Team?

Chul Kim, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can provide samples of my tumor tissue for the study.

I have HIV but am on effective treatment with an undetectable viral load.

I have another cancer type, but it won't affect this trial's treatment.

Exclusion Criteria

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

I am not currently receiving any cancer treatment.

I am taking corticosteroids for brain metastasis symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a fixed dose of 10 mg/kg of sacituzumab govitecan-hziy intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity

Until disease progression or unacceptable toxicity

2 visits per 21-day cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Govitecan

Trial Overview 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.

How Is the Trial Designed?

Group I: Sacituzumab Experimental Treatment 1 Intervention

Sacituzumab Govitecan is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Trodelvy for:

• Metastatic triple-negative breast cancer
• Locally advanced or metastatic urothelial cancer (withdrawn)
• Metastatic HR+/HER2- breast cancer

Approved in European Union as Trodelvy for:

• Metastatic triple-negative breast cancer

Approved in Canada as Trodelvy for:

• Metastatic triple-negative breast cancer

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

In a retrospective analysis of 81 patients with thymic malignancies, pemetrexed showed modest activity, with 62.5% of patients experiencing disease stabilization, particularly in thymoma patients who had a median progression-free survival (PFS) of 13.8 months.

The study indicates that pemetrexed can provide clinically meaningful outcomes in thymic malignancies, with a partial response observed in 17% of thymoma patients and a median overall survival (OS) of 20.1 months for thymoma and 12.7 months for thymic carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pemetrexed in patients with thymic malignancies previously treated with chemotherapy. Liang, Y., Padda, SK., Riess, JW., et al.[2022]

In a phase II study of 33 patients with thymic epithelial tumors (TET) who had progressed after platinum-based chemotherapy, pembrolizumab demonstrated encouraging antitumor activity, with 28.6% of thymoma patients and 19.2% of thymic carcinoma patients achieving a partial response.

While pembrolizumab showed efficacy, it was associated with a significant incidence of immune-related adverse events, particularly in patients with thymoma, highlighting the need for further research to optimize treatment and minimize side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for Patients With Refractory or Relapsed Thymic Epithelial Tumor: An Open-Label Phase II Trial. Cho, J., Kim, HS., Ku, BM., et al.[2020]

A multicenter phase II study is investigating the combination of atezolizumab (an anti-PD-L1 antibody) with carboplatin and paclitaxel in 47 patients with advanced or recurrent thymic carcinoma, aiming to improve treatment outcomes compared to standard chemotherapy.

The study will assess the safety and efficacy of this combination therapy, with the primary focus on the objective response rate, and will follow patients for up to 2 years to evaluate long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Design and Rationale for Marble Study: A Phase II Trial of Atezolizumab (MPDL3280A) Plus Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Thymic Carcinoma (JTD2101). Asao, T., Shukuya, T., Mimori, T., et al.[2023]

In a multicenter phase II study involving 15 patients with metastatic thymic epithelial tumors, the combination of capecitabine and gemcitabine (CAP-GEM) demonstrated a promising objective response rate of 40%, with complete and partial responses observed in 20% of patients each.

The treatment was generally well-tolerated, with manageable side effects primarily including grade 1-2 neutropenia, anemia, and thrombocytopenia, and a median progression-free survival of 11 months, suggesting that CAP-GEM could be an effective option for pretreated TETs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs). Palmieri, G., Merola, G., Federico, P., et al.[2022]

Sunitinib, a tyrosine kinase inhibitor, has been shown to be effective in a phase II trial for patients with thymic carcinoma who have already undergone previous treatments.

This study provides the first viable second-line treatment option for patients suffering from this rare and aggressive type of thymus cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sunitinib effective for rare thymus cancer. [2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39753485/

Phase II Parallel Arm Study of Sacituzumab Govitecan-Hziy ... Sacituzumab govitecan-hziy, a Trop-2-directed antibody-drug conjugate, has shown efficacy and safety in several tumors including breast cancer. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06248515

NCT06248515 | A Phase II Trial of Sacituzumab Govitecan ... The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma.

3. stanfordhealthcare.org stanfordhealthcare.org/trials/a/NCT06248515.html

A Phase II Trial of Sacituzumab Govitecan in Patients With ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1556086424013789

P2.14B.03 A Phase II Parallel Arm Study of Sacituzumab ... Sacituzumab govitecan-hziy, a Trop-2-directed antibody-drug conjugate, has shown efficacy and safety in several tumors including breast cancer and urothelial ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2020/761115Orig1s000MultidisciplineR.pdf

761115Orig1s000 - accessdata.fda.gov No integrated efficacy analysis was performed during this review. Based on the data submitted from IMMU-132-01, sacituzumab govitecan demonstrates evidence.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01631552

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults ... The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day ...