Sacituzumab Govitecan for Thymic Cancer

Recruiting at 2 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

Trial Summary

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.

How is the drug Sacituzumab Govitecan unique for treating thymic cancer?

Sacituzumab Govitecan is unique because it is an antibody-drug conjugate, which means it combines an antibody that targets cancer cells with a chemotherapy drug, allowing for direct delivery of the chemotherapy to the cancer cells. This targeted approach may offer a novel treatment option for thymic cancer, which currently has limited effective therapies. ^{1 2 3 4 5}

What is the purpose of 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.

Research Team

Chul Kim, MD

Principal Investigator

[e-mail]

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pembrolizumab for Patients With Refractory or Relapsed Thymic Epithelial Tumor: An Open-Label Phase II Trial. [2020]

2. England 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). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Sunitinib effective for rare thymus cancer. [2018]

4. United States 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). [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Pemetrexed in patients with thymic malignancies previously treated with chemotherapy. [2022]