Clinical trial · Interventional
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Reasons
Summary
Brief summary (as posted)
This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER-2 Protein Overexpression | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACTR T Cell Product | Biological | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ACTR T cell product in combination with trastuzumab
- interventionNames
- Biological: ACTR T Cell Product
- Drug: Trastuzumab
Primary outcomes (2)
- measure
- Safety and tolerability of ACTR T cell product with trastuzumab as assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of adverse events (AEs) and clinically significant abnormalities of laboratory values
- timeFrame
- 42 days
- measure
- Determination of recommended phase 2 dose (RP2D) regimen
- timeFrame
- 42 days
- description
- Review of DLTs, maximum tolerated dose (MTD), incidence and severity of AEs and clinically significant abnormalities of laboratory values
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent obtained prior to study procedures * Histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer * Subjects must have previously received adequate standard therapy for treatment of their malignancy * For those with metastatic breast cancer, must have received HER2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting * For those with advanced gastric cancer, adequate prior treatment with HER2-directed chemotherapy is required * At least 1 measurable lesion by iRECIST * Able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-HER2 mAb-directed therapy * ECOG of 0 or 1 * Life expectancy ≥ 6 months * LVEF ≥ 50% by MUGA or ECHO * Absolute neutrophil (ANC) count ≥ 1500/ µL * Platelet count ≥ 100,000/µL * Hemoglobin ≥ 9g/dL * Estimated GFR \>30mL/min/1.73m2 Exclusion Criteria: * glioblastoma multiforme or other primary CNS tumors are excluded * clinically significant cardiac disease * clinically significant active infection * clinical history, prior diagnosis, or overt evidence of autoimmune disease * current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid) * Prior treatment as follows: * prior cumulative doxorubicin dose greater than or equal to 300 mg/m\^2 or equivalent * chemotherapy within 2 weeks of enrollment * external beam radiation within 2 weeks of enrollment (28 days if CNS-directed therapy) * any monoclonal antibody (mAb) or other protein therapeutic containing Fc-domains within 4 weeks of enrollment * pertuzumab within 4 months of enrollment * Experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter * allogeneic hematopoietic stem cell transplant (HSCT) * prior infusion of a genetically modified therapy * Pregnant or breastfeeding
References
Publications (0)
Data not yet available