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

ConditionsSST2-positive Neuroendocrine NeoplasmsNeuroendocrine TumorsNeuroendocrine Neoplasm
Trial statusActive, not recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCrinetics Pharmaceuticals Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • CRN09682

    Drug

    Study drug CRN09682 intravenously

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose Expansion: Cohort 1Experimental treatment 1 intervention
Group C: Dose Expansion: Cohort 2Experimental treatment 1 intervention
Group D: Dose Expansion: Cohort 3Experimental treatment 1 intervention
Group E: Dose Expansion: Cohort 4Experimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Crinetics Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: