OncoMatch/Clinical Trials/NCT06353997
Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients
Is NCT06353997 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and INBRX-106 for triple negative breast cancer.
Treatment: Pembrolizumab · INBRX-106 — This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression ≤ 10% (≤ 10%)
ER/PR ≤ 10% allowed
Required: PR (PGR) expression ≤ 10% (≤ 10%)
ER/PR ≤ 10% allowed
Required: HER2 (ERBB2) negative (IHC 0, 1+, or 2+ with negative ISH)
HER2- as defined by ASCO guidelines. HER2 negative permitted to enroll as IHC 0, 1, or 2+ with negative ISH.
Disease stage
Required: Stage II, III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy
Exception: Patients who have received these agents more than 3 years prior for other malignancies may be considered if they are not still at clinically significant risk of systemic recurrence in the opinion of the investigator.
Prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100 000/µL; Hemoglobin ≥8.0 g/dL or ≥5.0 mmol/L
Kidney function
Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN. Patients with elevated LFTs that are suggestive of Gilbert's disease (a benign process) are eligible.
Patients must have adequate organ function as defined below. ... see full criteria for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ellison Institute of Technology (EITM) · Los Angeles, California
- Providence Portland Cancer Institute - Franz Clinic · Portland, Oregon
- Providence St. Vincent Medical Center · Portland, Oregon
- Swedish Cancer Institute · Seattle, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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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