Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision based on strategic re-alignment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-expressing Non-small Cell Lung Cancer | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| HER2-positive Colorectal Cancer | HER2-Positive Colorectal Carcinoma | ALIAS | 0.90 |
| HER2-positive Gastric Cancer | HER2-Positive Gastric Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| SBT6050 | Drug | — | UNRESOLVED |
| trastuzumab | Drug | Trastuzumab | ALIAS |
| trastuzumab deruxtecan | Drug | — | UNRESOLVED |
| tucatinib | Drug | Tucatinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- SBT6050 + T-DXd (5.4 mg/kg)
- description
- SBT6050 plus trastuzumab deruxtecan
- interventionNames
- Drug: SBT6050
- Drug: trastuzumab deruxtecan
- type
- EXPERIMENTAL
- label
- SBT6050 + T-DXd (6.4 mg/kg)
- description
- SBT6050 plus trastuzumab deruxtecan
- interventionNames
- Drug: SBT6050
- Drug: trastuzumab deruxtecan
- type
- EXPERIMENTAL
- label
- SBT6050 + Tucatinib + Trastuzumab + Capecitabine
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available