OncoMatch/Clinical Trials/NCT05491083
Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer
Is NCT05491083 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Pembrolizumab & ADG106 (Phase Ib) and Pembrolizumab & ADG106 (Phase II) for advanced solid tumor.
Treatment: Pembrolizumab & ADG106 (Phase Ib) · Pembrolizumab & ADG106 (Phase II) — This is a phase Ib followed by phase II clinical trial evaluating the safety and efficacy of combination of ADG106 with pembrolizumab in patients with metastatic cancers. The Phase Ib dose finding part will include all solid tumor subtypes with treatment refractory disease, while phase II will focus on only patients with TNBC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <1% (<1%)
expression of estrogen (ER) ... <1%
Required: PR (PGR) expression <1% (<1%)
expression of ... progesterone receptors (PR) of <1%
Required: HER2 (ERBB2) IHC score of 0 or 1+ or IHC score of 2+ but FISH negative (IHC 0 or 1+ or 2+ but FISH negative)
HER2 IHC score of 0 or 1+ or HER2 IHC score of 2+ but HER2 FISH negative
Required: PD-L1 (CD274) CPS ≥1 (CPS ≥1)
Tumor CPS≥1 determined by the DAKO 22C3 assay assessed by local or central laboratory
Disease stage
Metastatic disease required
advanced or metastatic solid tumors who have radiological evidence of progressive disease on study entry; Measurable disease by RECIST 1.1 criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — metastatic
Received at least 1 line but no more than 2 prior lines of systemic therapy in the metastatic setting, including chemotherapy or targeted therapy (e.g., PARP inhibitors)
Cannot have received: immune checkpoint inhibitor
Exception: prior immune checkpoint inhibitors are allowed for phase Ib
Prior treatment with immune checkpoint inhibitor in phase II; prior immune checkpoint inhibitors are allowed for phase Ib
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L; Hemoglobin ≥9 x 10^9/L
Kidney function
Calculated creatinine clearance of ≥60 mL/min (Cockroft and Gault formula)
Liver function
Bilirubin ≤1.5x ULN; ALT or AST ≤2.5x ULN (or ≤5x ULN with presence of liver metastases)
Adequate bone marrow function and organ function within 2 weeks of study treatment. Hematologic: ANC ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L; Hemoglobin ≥9 x 10^9/L. Hepatic: Bilirubin ≤1.5x ULN; ALT or AST ≤2.5x ULN (or ≤5x ULN with presence of liver metastases). Renal: Calculated creatinine clearance of ≥60 mL/min (Cockroft and Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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