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New treatment option for Small-cell Lung Cancer
Official title A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07174583
What this study is testing
What is IDE849?
IDE849 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small-cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF.
- people with histologically or cytologically confirmed ES- SCLC, neuroendocrine carcinoma (NEC), DLL3+ solid tumors, are eligible per protocol. people...
- people with NEC, this includes
- High-grade gastroenteropancreatic NEC
- NEC of the prostate
You likely can't join if
- Have mixed SCLC and NSCLC histology are not allowed (SCLC with components of large cell NEC are eligible). Participants with limited stage SCLC are...
- people with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.
- Have had other malignancies within 2 years prior to the first dose, except adequately treated carcinoma in situ (cervical, breast, or other), basal...
- Have uncontrolled tumor-associated pain.
- Have severe cardiovascular and cerebrovascular disease
- Have history of clinically significant bleeding within 3 months before the first study dose.
See the full eligibility criteria
Who can join
- Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF.
- people with histologically or cytologically confirmed ES- SCLC, neuroendocrine carcinoma (NEC), DLL3+ solid tumors, are eligible per protocol. people must have radiologically progressed or recurred after previous...
- people with NEC, this includes
- High-grade gastroenteropancreatic NEC
- NEC of the prostate
- Small cell NEC of any other organ
- Merkel cell carcinoma
- Transformed non-small cell adenocarcinoma of the lung (including but not limited to epidermal growth factor receptor or Kirsten rat sarcoma viral oncogene homolog mutated adenocarcinoma of the lung post progression on...
- Any other NEC that does not meet any of the indications noted above.
- people with other solid tumors demonstrated to express moderate/high expression of DLL3 including metastatic melanoma, Grade 3 gastrointestinal and pancreatic NETs, and pulmonary carcinoids.
- metastatic melanoma
- people will be required to provide blood/tumor tissue samples for biomarker testing.
- Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- Have life expectancy \> 3 months.
- Have adequate bone marrow and organ function within 7 days of the first dose (no use of any blood components and/or cell growth factors within 14 days prior to the start of the study treatment).
- Women of childbearing potential (WOCBP) must agree to take highly effective contraceptive measures from signing of consent through 8 months after the last dose of IDE849; men with partners of child-bearing potential...
What rules you out
- Have mixed SCLC and NSCLC histology are not allowed (SCLC with components of large cell NEC are eligible). Participants with limited stage SCLC are ineligible.
- people with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.
- Have had other malignancies within 2 years prior to the first dose, except adequately treated carcinoma in situ (cervical, breast, or other), basal cell or squamous cell skin cancer, localized prostate cancer after...
- Have uncontrolled tumor-associated pain.
- Have severe cardiovascular and cerebrovascular disease
- Have history of clinically significant bleeding within 3 months before the first study dose.
- Have history of interstitial pneumonitis during previous treatment; current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate...
- Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening (HIV antibody positive and HIV-RNA above the lower limit of detection of the analytical method).
- people with known or suspected viral hepatitis.
- Have a history of active tuberculosis within 1 year before enrollment.
- For participants enrolling to receive the combination with durvalumab, must not be deemed by the Investigator to be unsuitable to receive immunotherapy, or have had any prior intolerance to PD-1/PD-L1 inhibitor therapy...
- For participants enrolling to receive the combination with IDE161, must not have had prior GI or upper bowel removal or any other gastrointestinal disorder or defect (eg, malabsorption disorder such as Crohn's disease...
- For patients receiving a combination with carboplatin, be deemed by the Investigator to be unsuitable to receive platinum-based chemotherapy, or have had intolerance to platinum-based chemotherapy
- Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; for small molecule treatments within 2 weeks before...
- Administration of any of the following:
- Use of drugs that are inhibitors of P-gp, BCRP, and OATPIB1/OATP1B3
- Use of drugs with known risk of QT prolongation within 5 half-lives of their administration.
- For participants enrolling to receive the combination with IDE161:
- Use of drugs of narrow therapeutic index that are sensitive substrates of MATE2-K, BCRP, and P-gp
- Use of known moderate and strong CYP3A4/5 inducers and inhibitors is not permitted
- Administration of PPIs
- Use of an H2 blocking agent
- Use of a local antacid
- Use of drugs with a known risk of QT prolongation
- Have prior treatment with DLL3 ADC with a Topo1 inhibitor payload (except for participants enrolling to receive the IDE161 combination).
- For participants enrolling to receive the combination with durvalumab, have history of prior intolerance to PD-1/PD-L1 inhibitors.
- Have received \> 30 Gy of chest radiotherapy within 8 weeks prior to the first dose of the IMP, \> 30 Gy of non-chest radiotherapy within 14 days prior to the first dose (people who have completed radiotherapy for brain...
- Have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose.
- Female people who are pregnant, lactating, or planning to become pregnant during the study period to 8 months after the last dose of the IMP.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Orlando, Florida, United States
- Fort Wayne, Indiana, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Orlando, Florida, United States; Fort Wayne, Indiana, United States; Grand Rapids, Michigan, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.