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Tests treatment safety and results for SST2-positive Neuroendocrine Neoplasms
Official title A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors
ClinicalTrials.gov ID: NCT07129252
What this study is testing
What is CRN09682?
CRN09682 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sst2-positive neuroendocrine neoplasms.
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 Phase 1/2, multicenter, open-label, FIH study aims to evaluate the safety, tolerability, PK, and preliminary antitumor activity of CRN09682 in participants with SST2-expressing NENs and other solid tumors. The study includes a Dose Escalation Phase to determine the MTD and DLTs.
- 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
- Have a histological diagnosis of metastatic or locally advanced inoperable NET, NEC, or other solid tumors that have confirmed radiological...
- Have one or more measurable disease location per RECIST version 1.1.
- Have a tumor that expresses SSR confirmed by SSR imaging.
- Have an ECOG performance status of 0, 1, or 2.
You likely can't join if
- Have tumor progression while undergoing a course of PRRT or within 6 months of completing PRRT.
- Have brain metastases unless asymptomatic and stable for at least one month for participants with SCLC or LCLC or at least 3 months for participants...
- Use of anticancer agents within specified intervals prior to the first dose of study drug.
- Had surgery, chemoembolization, or radiofrequency ablation within 90 days prior to first dose of study drug.
- Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
- Participants with carcinoid syndrome.
See the full eligibility criteria
- Have a histological diagnosis of metastatic or locally advanced inoperable NET, NEC, or other solid tumors that have confirmed radiological progression.
- Have one or more measurable disease location per RECIST version 1.1.
- Have a tumor that expresses SSR confirmed by SSR imaging.
- Have an ECOG performance status of 0, 1, or 2.
- Have tumor progression while undergoing a course of PRRT or within 6 months of completing PRRT.
- Have brain metastases unless asymptomatic and stable for at least one month for participants with SCLC or LCLC or at least 3 months for participants with other non-NET solid tumors.
- Use of anticancer agents within specified intervals prior to the first dose of study drug.
- Had surgery, chemoembolization, or radiofrequency ablation within 90 days prior to first dose of study drug.
- Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
- Participants with carcinoid syndrome.
- Secondary malignancy: participants who have any other malignancy known to be active or treated within 3 years of the start of screening, with the exception of treated cervical intraepithelial neoplasia, superficial...
- Have prior treatment with MMAE.
- Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and/or MMAE.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Duarte, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Lexington, Kentucky, United States
- Metairie, Louisiana, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
+ 3 more site(s).
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 Phoenix, Arizona, United States; Duarte, California, United States; Newport Beach, California, United States; Orange, California, United States; San Francisco, California, United States; Denver, Colorado, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.