A study to learn more about how well treatment with sevabertinib (BAY2927088) tablets works and how safe it is in participants who have a solid tumor with mutations of the human epidermal growth factor receptor 2 (HER2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bayer Consumer Care AG, Bayer AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 Feb 2025 → ongoing

Decision date (initial)

2025-02-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bayer Consumer Care AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of sevabertinib in objective response rate (ORR) as assessed by blinded independent central review (BICR)

Secondary objectives 5

1. To further evaluate the efficacy of sevabertinib on tumor growth as assessed by BICR and investigator
2. To further characterize the efficacy of sevabertinib on tumor growth as assessed by BICR and investigator
3. To evaluate the efficacy of sevabertinib in overall survival (OS)
4. To assess the safety and tolerability of sevabertinib
5. To evaluate patient-reported outcomes (PROs) of sevabertinib

Conditions and MedDRA coding

HER2 mutation

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC)
2. Participant must be ≥18 years of age or over the legal age of consent
3. Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
4. Documented activating HER2 mutation
5. At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria

Exclusion criteria 4

1. Primary diagnosis of non-small cell lung cancer(NSCLC)
2. Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
3. Active brain metastases
4. Uncontrolled, severe, intercurrent illness

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR)

Secondary endpoints 16

1. Duration of response (DOR) per RECIST 1.1 as assessed by BICR
2. Time to response (TTR) per RECIST 1.1 as assessed by BICR
3. ORR per RECIST 1.1 as assessed by the investigator
4. Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
5. DCR ≥12 weeks per RECIST 1.1 as assessed by BICR
6. Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
7. Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
8. DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator
9. Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator
10. DOR per RECIST 1.1 as assessed by the investigator
11. TTR per RECIST 1.1 as assessed by the investigator
12. Overall survival (OS)
13. Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity. Number of participants who discontinue study treatment due to an AE
14. Time to deterioration in EORTC QLQ-C30 physical functioning domain score
15. Change from baseline in EORTC QLQ-C30 physical functioning domain score
16. Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)

Investigational products

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

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer Consumer Care AG

Sponsor organisation

Bayer Consumer Care AG

Address

Peter Merian-Strasse 84

City

Basel

Postcode

4052

Country

Switzerland

Scientific contact point

Organisation

Bayer AG

Contact name

Bayer Clinical Trials Contact

Public contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Third parties 11

Bayer AG

Sponsor organisation

Bayer AG

Address

-

City

Leverkusen

Postcode

51368

Country

Germany

Sponsor responsibilities

Article 77 compliance

Bayer Consumer Care AG

Article 77 implementation

Bayer Consumer Care AG

Locations

4 EU/EEA countries · 18 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 49 files

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

Application history

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