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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Crinetics Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

19 Dec 2025 → ongoing

Decision date (initial)

2026-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Crinetics Pharmaceuticals, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacokinetic, Safety, Others

Dose Escalation Phase: To assess the safety and tolerability of CRN09682 in participants with progressive SST2-expressing NENs or other SST2-expressing relapsed or refractory solid tumors.
Dose Expansion Phase: To assess the safety and tolerability of CRN09682 when administered at the dose selected for expansion in participants with progressive SST2-positive NENs or other SST2-positive relapsed or refractory solid tumors.

Secondary objectives 5

1. Dose Escalation Phase: To characterize the plasma PK of CRN09682 and MMAE.
2. Dose Escalation Phase: To make a preliminary assessment of the antitumor activity of CRN09682.
3. Dose Escalation Phase: To select a dose(s) for cohort expansion (Expansion Dose) based on the exposure-response and exposure-toxicity relationships established during dose escalation.
4. Dose Expansion Phase: To make a preliminary assessment of the antitumor activity of CRN09682 as a single agent at the dose selected for expansion in participants with progressive SST2-positive NENs or other SST2-positive relapsed or refractory solid tumors.
5. Dose Expansion Phase: To further characterize the plasma PK of CRN09682 and MMAE at the dose selected for expansion.

Conditions and MedDRA coding

Metastatic or locally advanced SST2-positive neuroendocrine neoplasms in adults

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Have a histological diagnosis of metastatic or locally advanced inoperable NET, NEC, or other solid tumors that have confirmed radiological progression.
2. Have one or more measurable disease location per RECIST version 1.1.
3. Have a tumor that expresses SSR confirmed by SSR imaging.

Exclusion criteria 9

1. Have tumor progression while undergoing a course of PRRT or within 6 months of completing PRRT.
2. 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.
3. Use of anticancer agents within the following intervals prior to the first dose of study drug.
4. Had any surgery, chemoembolization, or radiofrequency ablation within 90 days prior to first dose of study drug.
5. Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to first dose of study drug.
6. Participants with carcinoid syndrome.
7. 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.
8. Have prior treatment with MMAE.
9. Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and/or MMAE.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Dose Escalation Phase: Incidence and severity of DLTs.
2. Dose Escalation Phase: Incidence and severity of AEs and SAEs at each dose level.
3. Dose Escalation Phase: Incidence of AEs leading to discontinuation from study drug.
4. Dose Expansion Phase: Nature, incidence, and severity of AEs and SAEs at the Expansion Dose.
5. Dose Expansion Phase: Interruptions at the Expansion Dose.

Secondary endpoints 12

1. Dose Escalation Phase: Plasma PK parameters of CRN09682, including Cmax, tmax, AUC0-last, AUC0-inf, and t½.
2. Dose Escalation Phase: Plasma PK parameters of MMAE, including Cmax, tmax, and AUC0-last.
3. Dose Escalation Phase: ORR=PR+CR by RECIST version 1.1 criteria.
4. Dose Escalation Phase: DOR, defined as time from achieving at least a RECIST PR to disease progression.
5. Dose Escalation Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria.
6. Dose Escalation Phase: Safety, tolerability, PK, and response by dose level.
7. Dose Expansion Phase: ORR=PR+CR by RECIST version 1.1 criteria.
8. Dose Expansion Phase: DOR, defined as time from achieving at least a RECIST version 1.1 PR to disease progression.
9. Dose Expansion Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria.
10. Dose Expansion Phase: Radiographic PFS (defined as time from enrollment to disease progression).
11. Dose Expansion Phase: Changes in somatostatin receptor imaging.
12. Dose Expansion Phase: Plasma concentrations of CRN09682 and MMAE at predose and EOI.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Crinetics Pharmaceuticals Inc.

Sponsor organisation

Crinetics Pharmaceuticals Inc.

Address

6055 Lusk Boulevard

City

San Diego

Postcode

92121-2700

Country

United States

Scientific contact point

Organisation

Crinetics Pharmaceuticals Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Crinetics Pharmaceuticals Inc.

Contact name

Clinical Medical Lead

Locations

4 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 42 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications