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NCT Number: NCT07129252

A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors

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.

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Key information

Conditions

SST2-positive Neuroendocrine Neoplasms Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Neoplasm Neuroendocrine Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Crinetics Study Site, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRN09682

Drug

Study drug CRN09682 intravenously

Primary outcomes

  1. (Dose Escalation) Incidence and severity of DLTs.

    Time frame: 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.

    Time frame: 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.

    Time frame: From first dose of study drug to 30 days after the last dose.

  4. (Dose Expansion) Interruptions at the Expansion Dose.

    Time frame: At Day 1 of each cycle through study completion, approximately 2 years.

Secondary outcomes

  1. (Dose Escalation) Maximum Plasma Concentration (Cmax) of CRN09682 and MMAE .

    Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

  2. (Dose Escalation) Time to Maximum Concentration (Tmax) of CRN09682 and MMAE.

    Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

  3. (Dose Escalation) Measure of CRN09682 and MMAE exposure in the body from initial dose to the last measurable concentration (AUC0-last).

    Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

  4. (Dose Escalation) Measure of total CRN09682 exposure in the body across time (AUC0-inf).

    Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

  5. (Dose Escalation) The amount of time required for CRN09682 to be reduced to half of its initial concentration in the blood (t1/2).

    Time frame: Day 1 of each cycle (each cycle is 21 days) for the duration of the study, from baseline to safety follow-up visit, up to 2 years.

  6. (Dose Escalation & Expansion) Objective response rate (ORR): The percentage of patients with best overall response of complete response or partial response according to RECIST 1.1

    Time frame: Throughout the study until disease progression or the last evaluable assessment in the absence of progression whichever occurs first, approximately 2 years.

  7. (Dose Escalation & Expansion) Disease control rate (DCR): The percentage of patients with best overall response of complete response, partial response, or stable disease according to RECIST 1.1

    Time frame: Throughout the study until disease progression or the last evaluable assessment in the absence of progression whichever occurs first , approximately 2 years.

  8. (Dose Escalation & Expansion) Duration of response (DOR): The time from the date of first objective response until date of disease progression or death in the absence of disease progression, according to RECIST 1.1.

    Time frame: From the first documented objective response to disease progression or death whichever occurs first, approximately 2 years.

  9. (Dose Expansion) Changes in somatostatin receptor imaging: Evaluate changes in SSR tracer uptake over time, based on whether uptake is greater than or less than liver uptake.

    Time frame: Throughout the study at predefined intervals, approximately 2 years.

  10. (Dose Expansion) Radiographic PFS: The time from the start of study drug until RECIST 1.1 defined disease progression or death in the absence of disease progression.

    Time frame: Throughout the study until disease progression or death whichever occurs first, approximately 2 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Contact if you are a potential participant or caregiver

CONTACT

[email protected]

833-827-9741

Contact if you are an HCP/clinical site staff/other

CONTACT

[email protected]

833-827-9741

Sponsors and collaborators

Lead sponsor

Crinetics Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Acronym: BRAVESST2

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 19, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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