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A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05091528
Recruitment Status : Terminated (Sponsor decision based on strategic re-alignment)
First Posted : October 25, 2021
Results First Posted : August 18, 2022
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Silverback Therapeutics

Brief Summary:
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer HER2-positive Gastric Cancer HER2-positive Colorectal Cancer HER2-expressing Non-small Cell Lung Cancer Drug: SBT6050 Drug: trastuzumab deruxtecan Drug: tucatinib Drug: trastuzumab Drug: capecitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers
Actual Study Start Date : February 8, 2022
Actual Primary Completion Date : July 7, 2022
Actual Study Completion Date : July 7, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SBT6050 + T-DXd (5.4 mg/kg)
SBT6050 plus trastuzumab deruxtecan
Drug: SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles

Drug: trastuzumab deruxtecan
5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
Other Name: ENHERTU

Experimental: SBT6050 + T-DXd (6.4 mg/kg)
SBT6050 plus trastuzumab deruxtecan
Drug: SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles

Drug: trastuzumab deruxtecan
6.4 mg/kg by IV infusion in 21-day cycles
Other Name: ENHERTU

Experimental: SBT6050 + Tucatinib + Trastuzumab + Capecitabine
SBT6050 plus tucatinib, trastuzumab, and capecitabine
Drug: SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles

Drug: tucatinib
300 mg by mouth (PO) twice daily (BID)
Other Name: TUKYSA

Drug: trastuzumab
8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
Other Name: HERCEPTIN

Drug: capecitabine
1000 mg/m2 PO BID for 14 days of each 21-day cycle
Other Name: XELODA

Experimental: SBT6050 + Tucatinib + Trastuzumab
SBT6050 plus tucatinib and trastuzumab
Drug: SBT6050
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles

Drug: tucatinib
300 mg by mouth (PO) twice daily (BID)
Other Name: TUKYSA

Drug: trastuzumab
8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
Other Name: HERCEPTIN




Primary Outcome Measures :
  1. Proportion of Participants With Dose Limiting Toxicities [ Time Frame: 21 days ]
    Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.

  2. Number of Participants With Treatment-emergent Adverse Events [ Time Frame: 18 weeks ]
    Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.

  3. Number of Participants With Laboratory Abnormalities [ Time Frame: 18 weeks ]
    Clinically significant treatment-emergent laboratory abnormalities as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.

  4. Number of Participants With an Objective Response Rate [ Time Frame: 0 weeks ]
    Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose expansion cohorts.


Secondary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events [ Time Frame: 0 weeks ]
    Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose expansion cohorts.

  2. Number of Participants With an Objective Response Rate [ Time Frame: 18 weeks ]
    Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose escalation cohorts.

  3. Duration of Response for Participants With an Objective Response Rate [ Time Frame: 0 weeks ]
    The length of time from the participant's first complete response or partial response as assessed by RECIST Version 1.1 Criteria until disease progression or death. This outcome measure applies to all participants.

  4. Proportion of Participants With Clinical Benefit Rate [ Time Frame: 0 weeks ]
    Complete response, partial response, or durable stable disease as assessed by RECIST Version 1.1 Criteria. This outcome measure applied only to participants in the dose expansion cohorts.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced or metastatic HER2-expressing (IHC 2+ or 3+) or HER2-amplified solid tumors
  • Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria
  • Tumor lesion amenable for biopsy or able to submit an adequate recent archived tumor tissue for baseline testing, as follows:

    1. Breast cancer and colorectal cancer (CRC): archival biopsy tissue obtained after the last HER2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy
    2. Gastric cancer and non-small-cell lung cancer (NSCLC): archival biopsy tissue taken within the past 12 months and after completion of last HER2-directed therapy, or a fresh biopsy
  • ECOG Performance Status of 0 or 1
  • Adequate hematologic, hepatic, renal, and cardiac function

Exclusion Criteria:

  • History of allergic reactions to certain components of study treatment therapies
  • Untreated brain metastases
  • Currently active (or history of) autoimmune disease
  • Taking the equivalent of >10 mg / day of prednisone
  • Taking a medication that moderately induces CYP2C, strongly inhibits CYP2C8, or interacts with both enzymes (CYP3A and CYP2C8)
  • Uncontrolled or clinically significant interstitial lung disease (ILD) / pneumonitis that requires systemic corticosteroid treatment or suspected ILD / pneumonitis
  • HIV infection, active hepatitis B or hepatitis C infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05091528


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Silverback Therapeutics
Investigators
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Study Director: Naomi Hunder, MD Silverback Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Silverback Therapeutics:
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Responsible Party: Silverback Therapeutics
ClinicalTrials.gov Identifier: NCT05091528    
Other Study ID Numbers: SBT6050-201
First Posted: October 25, 2021    Key Record Dates
Results First Posted: August 18, 2022
Last Update Posted: August 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silverback Therapeutics:
SBT6050
HER2
breast cancer
gastric cancer
colorectal cancer
non-small cell lung cancer
TLR8
trastuzumab deruxtecan
tucatinib
trastuzumab
capecitabine
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Stomach Neoplasms
Neoplasms by Site
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Capecitabine
Trastuzumab
Tucatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors