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

SBT6050 + Tucatinib + Trastuzumab + Capecitabine

Overall Study

Triple Negative Breast Neoplasms

Head and Neck Neoplasms

Biliary Tract Cancer

Pembrolizumab

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Cemiplimab

Immunoglobulins

Immune Checkpoint Inhibitors

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

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.

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

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

pembrolizumab

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

This study has 5 parts. Part 1 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 to estimate the maximum tolerated dose (MTD) and determine the dose recommended for Part 2. Part 2 of the study will further evaluate SBT6050 in select HER2 expressing or amplified advanced malignancies.

Part 3 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 in combination with pembrolizumab to estimate the MTD and determine the dose recommended for Part 4. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies.

Part 5 of the study will evaluate the safety, tolerability, and activity of SBT6050 in combination with cemiplimab in select HER2 expressing or amplified advanced malignancies.

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

A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers	NCT05091528	HER2-positive B... HER2-positive G... HER2-positive C... HER2-expressing...	SBT6050 trastuzumab der... tucatinib trastuzumab capecitabine trastuzumab der...	18 Years -	Silverback Therapeutics
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors	NCT04460456	HER2 Positive S...	SBT6050 pembrolizumab Cemiplimab	18 Years -	Silverback Therapeutics

Spots Global Cancer Trial Database for tlr8

Every month we try and update this database with for tlr8 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tlr8

Every month we try and update this database with for tlr8 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tlr8 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.