A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing … (NCT07129252) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors
United States, Spain150 participantsStarted 2025-11-26
Plain-language summary
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. Following MTD identification, additional participants will be enrolled at the expansion dose to further assess safety, tolerability, PK, and antitumor activity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria:
* 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 (noninvasive) bladder cancer, and non-melanoma skin cancer.
* Have prior treatment with MMAE.
* Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and/or MMAE.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
(Dose Escalation) Incidence and severity of DLTs.
Timeframe: From first dose through Day 21.
2
(Dose Escalation) Incidence and severity of AEs and SAEs at each dose level and incidence of AEs leading to discontinuation from study drug.
Timeframe: From first dose of study drug to 30 days after the last dose.
3
(Dose Expansion) Nature, incidence, and severity of AEs and SAEs at the Expansion Dose.
Timeframe: From first dose of study drug to 30 days after the last dose.
4
(Dose Expansion) Interruptions at the Expansion Dose.
Timeframe: At Day 1 of each cycle through study completion, approximately 2 years.