A Study in Patients With Advanced Breast Cancer

NCT04942054 | Terminated Phase 1 FDA Drug

• 1 other identifier: SCO-120-19-22
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 6

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.

Conditions

HER2-negative Breast Cancer; Advanced Breast Cancer; Hormone Receptor-positive Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicities at each dose levels (Part 1 only)

  28 Days/End of Cycle 1

• 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

Secondary Outcomes (4)

• evaluation of Cmax (Part 1 and Part 2)

  Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)

• evaluation of tmax (Part 1 and Part 2)

  Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)

• evaluation of AUC (Part 1 and Part 2)

  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.

Other Outcomes (1)

• pharmacodynamic biomarker

  At Screening and End of Cycle 1' (Each Cycle of 28 days)

Study Arms (1)

SCO-120

EXPERIMENTAL

Drug: Part 1; Drug: Part 2; Drug: Part 3

Interventions

Part 1 DRUG

Dose escalation cohort

SCO-120

Part 2 DRUG

Pharmacodyanamic (PD) dose exploration cohorts

SCO-120

Part 3 DRUG

Dose expansion at dose(s) ≤ maximum tolerated dose (MTD) cohort

SCO-120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (6)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

HealthCare Global Enterprises Ltd

Bangalore, Karnataka, 560027, India

Location

HCG Manavata cancer Centre

Nashik, Maharashtra, 422002, India

Location

LMMF's Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, 411004, India

Location

Noble Hospital Pvt. Ltd.,

Pune, Maharashtra, 411013, India

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 3 X 3 Design, sequential doses of 300 mg, 600 mg, 800 mg, 1200 mg will be studied. Other dose strength will be studied based on results.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 28, 2021
• Study Start: May 20, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IN (4)