OncoMatch/Clinical Trials/NCT07137416
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
Is NCT07137416 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Trastuzumab Deruxtecan and Pidnarulex for anatomic stage iii breast cancer ajcc v8.
Treatment: Pidnarulex · Trastuzumab Deruxtecan — This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
HER2-positive (IHC 3+) solid cancers
Required: HER2 (ERBB2) low expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)
HER2-low, with HER2-low defined as IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested
Required: HER2 (ERBB2) ultralow expression (IHC 0 with membrane staining)
HER2-ultralow defined as IHC 0 with membrane staining
Allowed: ESR1 expression
Any estrogen receptor (ER) and progesterone receptor (PR) expression is permitted but must be known
Allowed: PR (PGR) expression
Any estrogen receptor (ER) and progesterone receptor (PR) expression is permitted but must be known
Disease stage
Required: Stage III, IV (AJCC v8)
Metastatic disease required
locally advanced or metastatic disease; unresectable
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy
Patients must have had at least one prior line of cytotoxic chemotherapy
Cannot have received: anthracycline
Exception: Receipt of anthracycline in the (neo)adjuvant setting is allowed, provided that disease recurrence occurred later than 6 months after the completion of treatment
Patients must not have progressed on a prior anthracycline in the metastatic setting
Lab requirements
Blood counts
ANC ≥ 1,500/mcL (no G-CSF within 1 week prior to screening); Platelets ≥ 100,000/mcL (no transfusions within 1 week prior to screening)
Kidney function
Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 (using Cockcroft-Gault equation for participants with creatinine levels above institutional ULN)
Liver function
Total bilirubin ≤ 1.5 × institutional ULN (or ≤ 2 × institutional ULN in patients with documented Gilbert's syndrome); AST/ALT ≤ 3 × institutional ULN (or ≤ 5 × ULN in patients with liver metastases)
Cardiac function
LVEF ≥ 50% by ECHO or MUGA within 28 days before enrollment; NYHA class II or better
ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Total bilirubin ≤ 1.5 × institutional ULN (or ≤ 2 × institutional ULN in patients with documented Gilbert's syndrome); AST/ALT ≤ 3 × institutional ULN (or ≤ 5 × ULN in patients with liver metastases); INR/PT and aPTT ≤ 1.5 × ULN; GFR ≥ 60 mL/min/1.73 m^2; LVEF ≥ 50% by ECHO or MUGA; NYHA class II or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber - Harvard Cancer Center LAO · Boston, Massachusetts
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