(Peak) A Clinical Study of CGT9486+Sunitinib vs Sunitinib in Patients with Gastrointestinal Stromal Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cogent Biosciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]

Trial duration

28 Mar 2023 → ongoing

Decision date (initial)

2022-10-03

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Cogent Biosciences, Inc.

External identifiers

EU CT number

2022-500637-80-00

WHO UTN

U1111-1276-1685

ClinicalTrials.gov

NCT05208047

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Efficacy, Pharmacokinetic, Safety

Part 2: To determine the efficacy of bezuclastinib+sunitinib vs sunitinib in subjects with GIST

Secondary objectives 1

1. Part 2 (key sec.): To evaluate efficacy parameters of bezuclastinib+sunitinib vs sunitinib in subjects with GIST

Conditions and MedDRA coding

gastrointestinal stromal tumor

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST (Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.)
2. Documented disease progression on or intolerance to imatinib. Imatinib intolerance is defined as discontinuation of imatinib due to (an) adverse event(s) related to treatment with imatinib that was not manageable with dose modifications.
3. Subjects must have received the following treatment: − Part 1a: Treatment with ≥1 prior lines of therapy for GIST − Part 1b: Treatment with ≥2 prior TKI for GISTs. (Note: Each different TKI is counted once regardless of how often it was used. If 2 different TKIs were used in combination, both TKIs are counted.) − Part 2: Prior treatment with imatinib only
4. Have at least 1 measurable lesion according to mRECIST v1.1 (non-nodal lesions must be ≥1.0 cm in the long axis or ≥double the slice thickness in the long axis)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
6. other protocol defined inclusion criteria apply

Exclusion criteria 5

1. Prior anticancer drug less than 5 half-lives of the parent drug and/or its active metabolite(s) or 14 days (whichever is shorter) prior to the first dose of study drug.
2. Known hypersensitivity to components of bezuclastinib or sunitinib
3. Known PDGFR driving mutations or known succinate dehydrogenase deficiency
4. Clinically significant cardiac disease
5. other protocol defined exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Part 2: PFS (defined as the time from randomization to disease progression or death from any cause, whichever occurs first) as determined by BICR using mRECIST v1.1

Secondary endpoints 2

1. Part 2 (key sec.): OS, defined as the time from randomization until the date of death
2. Part 2 (key sec.): ORR, as determined by BICR using mRECIST v1.1

Investigational products

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

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cogent Biosciences Inc.

Sponsor organisation

Cogent Biosciences Inc.

Address

275 Wyman Street

City

Waltham

Postcode

02451-1200

Country

United States

Scientific contact point

Organisation

Cogent Biosciences Inc.

Contact name

Peak Clinical Trial Information

Public contact point

Organisation

Cogent Biosciences Inc.

Contact name

Peak Clinical Trial Information

Third parties 14

Locations

11 EU/EEA countries · 47 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 274 files

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

Application history

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