Recruiting NCT07129252
A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CRN09682.
- Who it may be relevant to
- Registry conditions: SST2-positive Neuroendocrine Neoplasms, Neuroendocrine Tumors, Neuroendocrine Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Drug CRN09682
Study drug CRN09682 intravenously
Primary outcome measures
- (Dose Escalation) Incidence and severity of DLTs. [Time frame: From first dose through Day 21.]
- (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.]
- (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.]
- (Dose Expansion) Interruptions at the Expansion Dose. [Time frame: At Day 1 of each cycle through study completion, approximately 2 years.]
Secondary outcome measures (10)
- (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.]
- (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.]
- (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.]
- (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.]
- (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.]
- (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.]
- (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.]
- (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.]
- (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.]
- (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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 23 centers
- Crinetics Study Site — Phoenix
- Crinetics Study Site — Duarte
- Crinetics Study Site — Newport Beach
- Crinetics Study Site — Orange
- Crinetics Study Site — San Francisco
- Crinetics Study Site — Aurora
- Crinetics Study Site — Denver
- Crinetics Study Site — New Haven
- … and 15 more centers
Spain · 4 centers
- Crinetics Study Site — Barcelona
- Crinetics Study Site — Barcelona
- Crinetics Study Site — Madrid
- Crinetics Study Site — Madrid
Identifiers
NCT: NCT07129252 · CRN09682-191