Study Summary
The purpose of this research study is to investigate whether an investigational anti-cancer drug called Iadademstat can be safely combined with approved treatment paclitaxel for relapsed or refractory small cell lung cancer and extrapulmonary high grade neuroendocrine cancer patients whose cancer is no longer responding to initial chemotherapy.

Paclitaxel is an FDA-approved drug for the treatment of breast cancer. Paclitaxel binds to certain structures within cancer, halts multiplication of cells resulting in antitumor activity, and is routinely used for management of multiple types of cancers including yours. Iadademstat is an investigational drug not yet FDA approved. Iadademstat is a new drug that can suppress tumor growth by targeted activity.

Iadademstat will be dispensed to you to be taken at home. Iadademstat will be taken orally, daily for 5 days followed by 2 days off every week in the 21-day cycle on an empty stomach (to be taken 2 hours after a meal or 1 hour prior to meal). Paclitaxel will be administered intravenously day 1 of each cycle. You will be asked to take the study drugs as long as you are benefitting from the treatment or your disease does not get worse.

We will perform a safety follow-up 30 days after discontinuing the treatment. If your treatment is stopped for reasons other than progression of cancer, we will perform a long-term follow-up for 1 year. During this time, you will be followed every 6 weeks for the first 6 months and then every 8 weeks for the following 6 months. We will perform a survival follow-up, every 2 months for 1 year after removal from the study.

Approximately 42 patients will take part in this multicenter study.

Protocol: 22-1020 / IRB22-1020
Phase: II
Investigator: Namrata Vijayvergia, MD
Disease(s): Cervix, Colon, Esophagus, Liver, Lung, Other Digestive Organ, Other Endocrine System, Pancreas, Prostate, Rectum, Small Intestine, Stomach, Unknown Sites, Urinary Bladder
Full Title: GI-203: A Phase 2 Study of Iadademstat in Combination with Paclitaxel in Relapsed or Refractory Small Cell Lung Cancer and Extrapulmonary High Grade Neuroendocrine Carcinomas

ClinicalTrials.gov
Visit ClinicalTrials.gov for a full clinical trial description.

Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have histologically or cytologically confirmed metastatic or unresectable extrapulmonary G3 NEC (Ki-67 index > 20% with poorly-differentiated histology), SCLC, or prostate or bladder cancer with high-grade neuroendocrine or small cell component.
• Patients must have been previously treated with platinum-based chemotherapy regimens (cisplatin, carboplatin, or oxaliplatin). Patients may have received up to 3 lines of treatment in the metastatic setting that might include immune checkpoint inhibitors, but no previous taxane-based therapy. However, patients who have received neoadjuvant/adjuvant therapy with taxanes more than 6 months from enrollment are allowed to participate.
• Patients cannot have received more than 3 lines of therapy.
• Patients who have not received any platinum-based therapy will not be eligible.
• Patients cannot have untreated, symptomatic CNS metastases likely to interfere with the experimental therapy as per the investigator-sponsor.

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515.