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CTRI Number  CTRI/2022/05/042392 [Registered on: 05/05/2022] Trial Registered Prospectively
Last Modified On: 19/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study in patients with advanced breast cancer  
Scientific Title of Study   A Phase 1 Study to Determine Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone receptor positive, HER-2 negative Advanced Breast Cancer Patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT04942054  ClinicalTrials.gov 
SCO-120-19-22 Version 01/17 Sep 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Inamdar 
Designation  Vice President, Clinical Development 
Affiliation  Sun Pharma Advanced Research Limited 
Address  17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)

Mumbai
MAHARASHTRA
400093
India 
Phone    
Fax    
Email  clinical.trials@sparcmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Inamdar 
Designation  Vice President, Clinical Development 
Affiliation  Sun Pharma Advanced Research Limited 
Address  17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)

Mumbai
MAHARASHTRA
400093
India 
Phone    
Fax    
Email  clinical.trials@sparcmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Inamdar 
Designation  Vice President, Clinical Development 
Affiliation  Sun Pharma Advanced Research Limited 
Address  17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)

Mumbai
MAHARASHTRA
400093
India 
Phone    
Fax    
Email  clinical.trials@sparcmail.com  
 
Source of Monetary or Material Support  
Sun Pharma Advanced Research Company Limited 
 
Primary Sponsor  
Name  Sun Pharma Advanced Research Company Limited 
Address  17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400093, India.  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment
Modification(s)  		   India
United States of America  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pavithran Kheechilat  Amrita Institute of Medical Sciences (AIMS)  Ponnekara P.O, Kochi - 682041, India
Ernakulam
KERALA 		 4842851234

pavithrank@aims.amrita.edu 
Dr Aditya Adhav  HCG Manavata cancer Centre  Behind Shivang Auto, Mumbai Naka, 422002, India
Nashik
MAHARASHTRA 		 02536661111

draditya@mcrinasik.com 
Dr Satheesh CT  HealthCare Global Enterprises Ltd  HCG Tower, #8, P. Kalinga Rao Road, Sampangiram Nagar, 560027, India
Bangalore
KARNATAKA 		 8046607700

drsatheeshct@gmail.com 
Dr Chetan Deshmukh  LMMFs Deenanath Mangeshkar Hospital & Research Centre  Off Karve Road, Mhatre Bridge, Erandawane, 411004, India
Pune
MAHARASHTRA 		 02049152434

drchetandeshmukh@gmail.com 
Dr Krishna Kumar Rathnam  Meenakshi Mission Hospital  Lake Area, Melur Road, 625107, India
Madurai
TAMIL NADU 		 4524263000

kkrathnam@gmail.com 
Dr Minish Jain  Noble Hospital Pvt. Ltd.,  153 A, Magarpatta City Road, Hadapsar, 411013, India
Pune
MAHARASHTRA 		 022-69315555

minishjain009@gmail.com 
DrTapan Saikai  Prince Aly Khan Hospital  Prince Aly Khan Hospital Aga Hall, Nesbit Road, Mazgoan, 400010 India
Mumbai
MAHARASHTRA 		 2223777800

tapan.saikai@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
HealthCare Global Enterprises Central Ethics Committee  Approved 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee-DEENANATH MANGESHKAR HOSPITAL & RESEARCH CENTER  Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Noble Hospital Institutional Ethics Committee  Approved 
Prince Aly Khan Hospital Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Part 1: Dose escalation cohort   Drug : SCO-120 Dosage form: tablets frequency of administration: after an overnight fast of at least 8 hours and should maintain fasting for approximately 2 hours after SCO-120 dosing throughout the study. route of administration: Oral total duration of therapy: approx. of 12 months treatment duration 
Intervention  Part 2: Pharmacodyanamic (PD) dose exploration cohorts   Drug : SCO-120 Dosage form: tablets frequency of administration: after an overnight fast of at least 8 hours and should maintain fasting for approximately 2 hours after SCO-120 dosing throughout the study. route of administration: Oral total duration of therapy: approx. of 12 months treatment duration 
Intervention  Part 3: Dose expansion at dose(s) less than equal to maximum tolerated dose (MTD) cohort  Drug : SCO-120 Dosage form: tablets frequency of administration: after an overnight fast of at least 8 hours and should maintain fasting for approximately 2 hours after SCO-120 dosing throughout the study. route of administration: Oral total duration of therapy: approx. of 12 months treatment duration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All 3 parts of Study:

• Male or females, Age 18 years or older
• Histologically or cytologically diagnosed with ER+/HER2- adenocarcinoma of the breast cancer with an evidence of metastatic/loco-regionally recurrent disease/unresectable advanced disease not amenable to treatment with curative intent
• Documentation of ER-positive, HER2-negative status determined based on a biopsy performed at or after diagnosis of local or metastatic recurrence, utilizing an assay consistent with local standards
• Not more than 3 prior chemotherapeutic regimens
• ECOG performance status 0-1.
• Resolution of all adverse events of prior therapy or surgical procedures to National Cancer Institute (NCI) CTCAE v 5.0 Grade ≤1 (except alopecia)
• Adequate organ and immune system function as indicated by
laboratory values
• Patients of childbearing potential must practice an acceptable method of birth control as judged by the Investigator
• Female subjects must be non-lactating and non-breast feeding
• Male subjects should not father a child and must practice an acceptable method of birth control measures
Willing and available to participate for the entire study
• Willing and able to comply with protocol requirements
2. For Part 1& 2:
• Patient must have evaluable disease (according to RECIST 1.1).
• Documented disease progression or resistance to at least 1 prior
endocrine therapy (with or without CDK 4/6 therapy).
3. For Part 3
• Patient must have measurable lesions (according to RECIST 1.1)
• Part 3a: HR+ve, HER2- MBC patients with ESR1 mutations, resistance to atleast one priro endocrine therapy
• Part 3b: HR+ve HER2- MBC patients resistant to atleast one priro endocrine therapy
• Part 3c: HR+ve HER2- MBC patients resistant to atleast one priro endocrine therapy, disease progression on Fulvestrant and CDK4/6i
• Part 3d: Brain metastases secondary to ER+ve HER–ve Breast Cancer:
Measurable brain lesion (≥ 1) as per RANO-BM Criteria,
Tretament naive/ Treated- Stable/ Not requiring immediate local therapy
known/ Suspected leptomeningeal disease
on Stable corticosteriod dose for 7 days prior screeing
 
 
ExclusionCriteria 
Details 
1. All 3 parts of Study

• Major surgery <4 weeks of C1D1
• Evidence of organ dysfunction or inadequate bone marrow reserve or any clinically significant finidngs
• Patients with visceral crisis or impending visceral crisis and rapidly progressing disease
• Serology tests +ve for HIV, HCV, HBsAg
• Inability to swallow oral medication
• H/o any relevant allergy/hypersensitivity/idiosyncrasy to drugs/ chemically related to Study drug or its excipients
• Received an IMP within 30 days/5 half life to C1D1
• Prior treatment with other oral SERDs
• Use of concomitant medication that might reasonably influence the results or interpretation of the study
• Requires concurrent systemic anticancer treatment at any time during the study treatment period
• Known or suspected history of significant drug abuse/Alcohol as judged by the Investigator
• Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry
• Malabsorption syndrome/IBD/other illness that would affect oral absorption of Study drug
• Uncontrolled intercurrent illness that would limit compliance with study requirements / have impact on endpoints / safety
• ≤6 months H/o MI/unstable angina, ongoing > G2 cardiac dysrhythmia, prolonged QTcF/ uncontrolled AF, coronary/peripheral artery bypass graft,
HF of NYHA_Class II or greater and CVA (+TIA)
• H/o Endometrial intraepithelial neoplasia, other malignancy < 5 yrs prior to enrollment
• Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases, or leptomeningeal disease as indicated by clinical symptoms (not applicable to Part 3d), carcinomatous meningitis, cerebral edema, and/or progressive growth or pulmonary lymphangitic metastases.
• Current abnormal vaginal bleeding or symptomatic endometrial disorders.
2. For Part 2: Use of other ET that block the estrogen receptor: atleast 8 weeks before enrollment (28 weeks for fulvestrant)
For Part 2: Liver-only metastases (are not evaluable by FES-PET/CT imaging)
3. For Part 3: Any brain lesion requiring immediate local therapy (which includes but is not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases)
Requires increase in the dose of corticosteroids for control of CNS symptoms due to brain metastases
Poorly controlled (> 2 per month ) generalized or complex partial seizures
Who are taking concurrent enzyme-inducing antiepileptic drugs (EIAED)
Who has evidence of significant (ie, symptomatic) intracranial haemorrhage
Contra indications for repeated MRI assessments
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of dose limiting toxicities at each dose levels (Part 1 only)  28 Days/End of Cycle 1 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence and severity of adverse events with each dose level
The intensity of adverse events will be graded as per CTCAE, Version 5.0 and categorized as serious adverse events or non-serious adverse events. 		 upto 30 days of last dose 
evaluation of Cmax (Part 1 and Part 2)
Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will
be used in the final pharmacokinetic parameter calculations 		 Through Cycle 1 and Cycle 2 (Each cycle of 28 Days) 
evaluation of tmax (Part 1 and Part 2)
Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will
be used in the final pharmacokinetic parameter calculations 		 Through Cycle 1 and Cycle 2 (Each cycle of 28 Days) 
evaluation of AUC (Part 1 and Part 2)
Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will
be used in the final pharmacokinetic parameter calculations 		 Through Cycle 1 and Cycle 2 (Each cycle of 28 Days) 
tumour response  Every 8 weeks, for Time point Response (Partial Response[PR], Stable Disease[SD], Disease
progression [DP] or Complete Response [CR]), Through study completion, an average of 1 year 
pharmacodynamic biomarker  At Screening and End of Cycle 1 (Each Cycle of 28 days) 
 
Target Sample Size
Modification(s)  		 Total Sample Size="9"
Sample Size from India="8" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)
Modification(s)  		 22/07/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/11/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A Phase 1, Open label, Dose escalation and Dose expansion study of SCO-120 in HR +ve HER2-ve advanced/ metastatic breast cancer (MBC) patients to evalaute the safety, tolerability and prelimnary efficacy. Initial part with dose escalation is to determine the MTD and RP2D, and PK and PD characterisation. RP2D will be further evalauted for prelimnary efficacy in MBC patients with tretament failure on Aromatase Inhibitor/Fulvestrant/CDK4-6 inhibitors with or with out ESR1 mutation. 
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