Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Lung Neoplasms

Carcinoma

Colorectal Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Tucatinib

Trastuzumab deruxtecan

Capecitabine

Antimetabolites

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

SBT6050 plus tucatinib, trastuzumab, and capecitabine

Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles

SBT6050

5.4 mg/kg by intravenous (IV) infusion in 21-day cycles

trastuzumab deruxtecan

tucatinib

8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles

trastuzumab

1000 mg/m2 PO BID for 14 days of each 21-day cycle

capecitabine

6.4 mg/kg by IV infusion in 21-day cycles

Naomi Hunder, MD

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.

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

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

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.

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.

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.

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.

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.

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.

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.

Silverback Therapeutics

SBT6050 plus trastuzumab deruxtecan

SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles

trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles

SBT6050 + T-DXd (6.4 mg/kg)

SBT6050 plus tucatinib and trastuzumab

SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles

tucatinib: 300 mg by mouth (PO) twice daily (BID)

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

SBT6050 + Tucatinib + Trastuzumab

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Primary Tumor Type

Prior Therapy Regimens

All enrolled participants who received at least one dose of SBT6050.

Early termination leading to small numbers of participants analyzed.

Chief Scientific Officer

Participants who were enrolled and treated with at least 1 dose of SBT6050.

Proportion of Participants With Dose Limiting Toxicities

Number of Participants With Treatment-emergent Adverse Events

Number of Participants With Laboratory Abnormalities

SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles

SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles

No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor.

Number of Participants With an Objective Response Rate

Data not captured; study was terminated by Sponsor.

Duration of Response for Participants With an Objective Response Rate

Proportion of Participants With Clinical Benefit Rate

SBT6050 plus trastuzumab deruxtecan

SBT6050: Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles

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

SBT6050 + T-DXd (5.4 mg/kg)

SBT6050 plus tucatinib, trastuzumab, and capecitabine

SBT6050: Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles

tucatinib: 300 mg by mouth (PO) twice daily (BID)

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

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

Spots Global Cancer Trial Database for A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial