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
Official title: Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors
Is NCT07137416 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Targeted therapy
Other
Cancer type
Breast Carcinoma
Tumor Agnostic
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+/ISH- or IHC 1+/ISH- or IHC 1+/ISH untested)
HER2-positive (IHC 3+) solid cancers; HER2 positive defined by the current ASCO/CAP guidelines; HER2-low defined as IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested
Required: HER2 (ERBB2) 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) expression (IHC 0 with membrane staining)
HER2-ultralow defined as IHC 0 with membrane staining
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 in the metastatic setting
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. Receipt of anthracycline in the (neo)adjuvant setting is allowed, provided that disease recurrence occurred later than 6 months after the completion of treatment
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
GFR ≥ 60 mL/min/1.73 m^2 (Cockcroft-Gault equation for participants with creatinine above ULN)
Liver function
Total bilirubin ≤ 1.5 × ULN (or ≤ 2 × ULN in patients with Gilbert's syndrome); AST/ALT ≤ 3 × 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; no G-CSF within 1 week prior to screening; platelets ≥ 100,000/mcL; no transfusions within 1 week prior to screening; total bilirubin ≤ 1.5 × ULN (or ≤ 2 × ULN in patients with Gilbert's syndrome); AST/ALT ≤ 3 × ULN (or ≤ 5 × ULN in patients with liver metastases); 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 Cancer Institute · Boston, Massachusetts
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07137416 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anthracycline in the metastatic setting disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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