Clinical Trials Register

Summary
EudraCT Number:	2021-005238-40
Sponsor's Protocol Code Number:	EQ132-201
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-03-14
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2021-005238-40

A.3

Full title of the trial

A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants with Advanced Breast Cancer

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to evaluate the safety and efficacy of Lerociclib in participants with advanced breast cancer

A.4.1

Sponsor's protocol code number

EQ132-201

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05085002

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	EQRx, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	EQRx, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	EQRx, Inc.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	50 Hampshire Street
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	MA 02139
B.5.3.4	Country	United States
B.5.4	Telephone number	+1(617) 315-2255
B.5.5	Fax number	+1(866) 500-6515

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.1.1	Trade name	Lerociclib
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lerociclib
D.3.2	Product code	EQ132, G1T38
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lerociclib
D.3.9.1	CAS number	2096938-59-3
D.3.9.3	Other descriptive name	EQ132, G1T38
D.3.9.4	EV Substance Code	SUB201851
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.1.1	Trade name	Lerociclib
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lerociclib
D.3.2	Product code	EQ132, G1T38
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lerociclib
D.3.9.1	CAS number	2096938-59-3
D.3.9.3	Other descriptive name	EQ132, G1T38
D.3.9.4	EV Substance Code	SUB201851
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Metastatic Breast Cancer

E.1.1.1

Medical condition in easily understood language

Advanced Breast Cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10055113
E.1.2	Term	Breast cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10006289
E.1.2	Term	Benign and malignant breast neoplasms
E.1.2	System Organ Class	100000004872

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10006290
E.1.2	Term	Breast and nipple neoplasms malignant
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To characterize the safety and tolerability of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC.

E.2.2

Secondary objectives of the trial

• To investigate the efficacy of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC by line of therapy.
• To further characterize the safety and tolerability of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC.
• To assess change from baseline in global health status and qualify of life (QoL) in participants with 1L and 2L HR+/HER2- mBC by line of therapy
• To characterize the pharmacokinetic (PK) profile of lerociclib in combination with endocrine therapy in partipcants with 1L and 2L HR+/HER2- mBC

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Is capable of giving signed informed consent. This includes compliance with the requirements and restrictions listed in the study informed consent form (ICF) and in this protocol.
2. Must be at least 18 years of age, or the legal age of consent in the jurisdiction in which the study is taking place, at the time of giving signed informed consent.

Type of Participant and Disease Characteristics
3. Has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor-positive breast cancer by local laboratory.
4. Breast cancer is also HER2-negative and advanced (locoregionally recurrent; not amenable to curative therapy, eg, surgery and/or radiotherapy; or metastatic) and meets one of the following criteria:
• Newly diagnosed advanced/metastatic breast cancer, treatment-naïve.
• Relapsed with documented evidence of relapse following neoadjuvant (adjuvant) endocrine therapy, with no treatment for advanced/metastatic disease.
• Relapsed with documented evidence of relapse following completion of adjuvant endocrine therapy, then subsequently progressed with documented evidence of progression after one (1) line of endocrine therapy (with either tamoxifen or an AI) for advanced/metastatic disease.
• Newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one (1) line of endocrine therapy (with either tamoxifen, exemestane, or an AI [other than fulvestrant]).
5. Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 or 1.
6. Has adequate bone marrow and organ function, as defined by all of the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• Platelets ≥ 100 × 109/L
• Hemoglobin ≥ 9.0 g/dL
• International normalized ratio (INR) ≤ 1.5
• Creatinine clearance (CLcr) ≥ 60/mL, as estimated by Cockcroft-Gault equation
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) below
2.5 × upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 × ULN; OR, for participants with well-documented Gilbert’s Syndrome, direct bilirubin within normal range of the central laboratory
7. Baseline QTc interval is < 470 msec.
8. Is able to take/swallow oral medications.
9. Has received a locally approved vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Sex and Contraceptive/Barrier Requirements
10. Must meet all of the applicable requirements for pregnancy and contraception (...)

For the complete information on the “inclusion criteria” please check the Protocol section 5.1

E.4

Principal exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions
1. Has symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy, per the Investigator’s best judgment.
2. Has peritoneal carcinomatosis.
3. Has inflammatory breast cancer at Screening.
4. Has central nervous system (CNS) involvement, unless participant is at least 4 weeks from prior therapy completion to starting study treatment, has stable CNS tumor at the time of Screening, and is not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
5. Has any clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
6. Has a history of prolonged QT syndrome or Torsades de Pointes.

Prior/Concomitant Therapy
7. Has received prior treatment with chemotherapy (except neoadjuvant/adjuvant chemotherapy), or with any CDK4/6 inhibitor.
8. Has received prior treatment with fulvestrant.
9. Use of systemic estrogens (eg, hormonal contraception, hormone replacement therapy [HRT]).
10. Is currently receiving any of the following substances and cannot be discontinued 14 days prior to starting lerociclib:
• Known strong or moderate CYP3A inducers or strong inhibitors of CYP3A
• Substances that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5

Diagnostic Assessments
11. Ejection fraction of ≤ 45% on echocardiogram performed within the past 12 months, or documented history of congestive heart failure with reduced ejection fraction.
12. Oral temperature of > 38°C at Screening, or any evidence of SARS-CoV-2 infection.
13. Interstitial pneumonia or severe impairment of lung function, with the latter defined as having vital capacity AND diffusing capacity of the lung for carbon monoxide (DLCO) that are ≤ 50% of the normal predicted values OR having an oxygen (O2) saturation at rest in ambient environment of ≤ 88%.

E.5 End points

E.5.1

Primary end point(s)

Incidence of adverse events (AEs) and serious adverse events (SAEs)

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary analysis will occur approximately 6 months after the last participant receives the first dose.

E.5.2

Secondary end point(s)

• Objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) as assessed by Investigator
• Clinical benefit rate (CBR), defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD) (for at least 8 weeks) according to RECIST v1.1 as assessed by Investigator
• Progression-free survival (PFS), defined as the time from first dose of lerociclib until the date of documented progression of disease (PD) or death, according to RECIST v1.1 as assessed by Investigator
• Overall survival (OS), defined as the time from the date of first dose of lerociclib to the date of death due to any cause
• Duration of response (DOR), defined as the time from the date of first documented response until the date of confirmed PD or death, according to RECIST v1.1 as assessed by Investigator
• Time to response (TTR), defined as the time from first dose of lerociclib until the first documented response (CR or PR)
• Change from baseline in clinical laboratory parameters (hematology, clinical chemistry, coagulation, fasting lipid panel, and urinalysis)
• Change from baseline in vital signs and 12 lead electrocardiogram (ECG) parameters
• Clinically significant findings on physical examination

E.5.2.1

Timepoint(s) of evaluation of this end point

For time-point(s) see section E.5.1

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability, Patient-reported outcome (PRO)

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Mexico

United States

Italy

Belgium

Georgia

Moldova, Republic of

Ukraine

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LSLV

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

100

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Participants who have completed all scheduled clinical study visits and continue to show benefit from lerociclib will be eligible to participate in a rollover study for continued access to lerociclib.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-05-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-11-30

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials