UPCC 22225: A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants with Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors (BRAVESST2)

Investigating Safety and Effects of an Investigational Medication in Patients with SST2-Expressing Tumors

Enrolling By Invitation
18 years or above
All
Phase 1/2
150 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: SST2-positive Neuroendocrine Neoplasms, Neuroendocrine Tumors, Neuroendocrine Neoplasm
  • Age: 18 years or above
  • Gender: All

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.

This study investigates a treatment for patients with somatostatin receptor type 2 (SST2)-expressing neuroendocrine neoplasms (NENs) and other solid tumors. The purpose of this study is to evaluate the safety and effects of an investigational medication in individuals with these conditions.

Participants in the study will receive the investigational medication to assess its safety and how well it is tolerated. The study will include a dose escalation phase to find the maximum tolerated dose and identify any dose-limiting toxicities. Once the appropriate dose is determined, more participants will be included to further evaluate the medication's effects.

  • Who can participate: Participants must have a confirmed diagnosis of metastatic or locally advanced inoperable neuroendocrine tumors or other solid tumors that show progression. They need to have at least one measurable disease location and a tumor that expresses SST2. Participants should also have an ECOG performance status of 0, 1, or 2.
  • Study details: Participants will receive the investigational medication to assess its safety and effects. The study will begin with a dose escalation phase to determine the safest dose level, followed by an expansion phase to further evaluate the medication. Participants should not have received certain treatments recently or have specific health conditions that could interfere with the study.
Updated on 28 Jul 2026. Study ID: 25-2012
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