A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

NCT04460456 | Unknown Phase 1 FDA Drug

• 1 other identifier: SBT6050-101
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 12

Brief Summary

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies

Conditions

HER2 Positive Solid Tumors

Keywords

HER2; ERBB2; Immunotherapy; Gastric Cancer; Gastroesophageal junction; Breast Cancer; Triple Negative Breast Cancer; Stomach Cancer; Colorectal Cancer; Gastrointestinal Cancer; Non-Small Cell Lung Cancer; Monoclonal antibody; TLR8; TLR8 agonist; Antibody drug conjugate; Biliary tract cancer; Head and neck cancer; Urothelial cancer; Endometrial cancer; Pembrolizumab; Anti-PD-1 mAb; Cemiplimab

Outcome Measures

Primary Outcomes (4)

• The proportion of subjects experiencing dose limiting toxicities

  Part 1 and 3 only

  28 days

• The incidence and severity of adverse events (AEs) and serious adverse events

  Parts 1, 2, 3, 4, and 5

  2 years

• Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)

  Parts 2, 4, and 5

  2 years

• Duration of response, defined as the time from date of first response (CR or PR)

  Parts 2, 4, and 5

  2 years

Secondary Outcomes (7)

• Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)

  2 years

• Duration of response, defined as the time from date of first response (CR or PR)

  2 years

• Disease control rate, defined as CR, PR, or stable disease for at least 6 months

  2 years

• Estimates of selected pharmacokinetics (PK ) parameters for SBT6050

  2 years

• Estimates of selected pharmacokinetics (PK ) parameters for SBT6050

  2 years

Study Arms (3)

SBT6050 Monotherapy

EXPERIMENTAL

Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.

Drug: SBT6050

SBT6050 and pembrolizumab

EXPERIMENTAL

Escalating doses of SBT6050 in combination with pembrolizumab in Part 3 followed by expansion in Part 4 at the recommended dose determined in Part 3.

Drug: SBT6050; Drug: pembrolizumab

SBT6050 and cemiplimab

EXPERIMENTAL

SBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.

Drug: SBT6050; Drug: Cemiplimab

Interventions

SBT6050 DRUG

Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2

SBT6050 Monotherapy; SBT6050 and cemiplimab; SBT6050 and pembrolizumab

pembrolizumab DRUG

400 mg IV

SBT6050 and pembrolizumab

Cemiplimab DRUG

350 mg IV

SBT6050 and cemiplimab

Eligibility Criteria

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

You may qualify if:

• Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor
• Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive)
• Measurable disease per RECIST 1.1
• Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic, hepatic, and cardiac function

You may not qualify if:

• History of allergic reactions to certain components of SBT6050 or similar drugs
• Untreated brain metastases
• Active autoimmune disease or a documented history of autoimmune disease or syndrome
• Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection

Sponsors & Collaborators

• Silverback Therapeutics: lead

Study Sites (12)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sarah Cannon Research Institute/Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

Macquarie University Hospital Clinical Trials Unit

Sydney, New South Wales, 2109, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Breast Cancer Research Centre - WA

Nedlands, Western Australia, 6009, Australia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Breast Neoplasms; Triple Negative Breast Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms; Carcinoma, Non-Small-Cell Lung; Biliary Tract Neoplasms; Head and Neck Neoplasms; Endometrial Neoplasms

Interventions

pembrolizumab; cemiplimab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Biliary Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Naomi Hunder, MD

  Silverback Therapeutics

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 7, 2020
• Study Start: July 27, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); AU (3); KR (3)