A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced HR Positive and HER2-Negative BC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Carrick Therapeutics Limited

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 Oct 2023 → 3 Sep 2025

Decision date (initial)

2023-12-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Carrick Therapeutics Limited

External identifiers

EU CT number

2023-503903-27-00

WHO UTN

U1111-1288-5256

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Pharmacodynamic, Safety

To evaluate the efficacy of two doses of samuraciclib in combination with fulvestrant.

Secondary objectives 3

1. To further characterize the safety and tolerability of two doses of samuraciclib in combination with fulvestrant.
2. To further characterize the efficacy of two doses of samuraciclib in combination with fulvestrant (includes TP53 correlation).
3. To evaluate the PK of samuraciclib and fulvestrant.

Conditions and MedDRA coding

metastatic or locally advanced Hormone Receptor positive and Human Epidermal Growth Factor Receptor 2 negative breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Histologically confirmed diagnosis of BC. Evidence of metastatic or locally advanced disease, not amenable to resection or radiation therapy with curative intent and having the following specifics: estrogen receptor positive with or without progesterone receptor positive tumor; HER2-negative.
2. Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
3. Received prior AI in combination with a CDK4/6i in the following settings: locally advanced or metastatic, or adjuvant.
4. Known TP53 mutation status.
5. Participants must have measurable disease or bone only disease (which can be measurable or non-measurable) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
6. Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
8. Expected life expectancy of >12 weeks in the judgement of the treating investigator.

Exclusion criteria 7

1. Inflammatory BC.
2. Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
3. Prior treatment with: a selective estrogen receptor degrader (SERD) or similar agents in the advanced/metastatic setting; more than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
4. Inadequate hepatic, renal, and bone marrow function.
5. Clinically significant cardiovascular disease.
6. Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
7. Pregnant or breastfeeding women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical benefit response (CBR) (complete response [CR], partial response [PR], or stable disease [SD] (≥ 24 weeks after randomization)).

Secondary endpoints 3

1. Adverse events (AEs) and laboratory abnormalities as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
2. Progression free survival (PFS); Objective response rate (ORR); Duration of response (DOR).
3. Samuraciclib: Cmax and Ctrough; Fulvestrant: Ctrough.

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Carrick Therapeutics Limited

Sponsor organisation

Carrick Therapeutics Limited

Address

Block 1, Blanchardstown Corporate Park 1 Blanchardstown Corporate Park 1

City

Dublin 15

Postcode

D15 AKK1

Country

Ireland

Scientific contact point

Organisation

Carrick Therapeutics Limited

Contact name

Sheila O'Mahony

Public contact point

Organisation

Carrick Therapeutics Limited

Contact name

Sheila O'Mahony

Third parties 3

Locations

2 EU/EEA countries · 5 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 40 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