Overview

A Study in Patients With Advanced Breast Cancer

Status:
Not yet recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Criteria
Inclusion Criteria:

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

Exclusion Criteria:

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