Study of INBRX-105 in Patients With Solid Tumors
18 Years and older, Male and Female
Ph 1 INBRX-105 (primary)
NCI-2019-02844
Summary
This is a first-in-human, open-label, nonrandomized, four-part Phase 1 trial to determine the
safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose
(RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next
generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor
and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation
through 4-1BB agonism.
Eligibility
- Parts 1 and 3 (escalation cohorts): Patients with locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite standard therapy and for whom no further standard therapy exists.
- Parts 2 and 4 (expansion cohorts): Patients with non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, or urothelial (transitional) cell carcinoma, with locally advanced or metastatic, non-resectable disease, which has progressed despite standard therapy or for whom no standard or clinically acceptable therapy exists.
- Part 4 treatment naive NSCLC cohort: Locally advanced or metastatic, non-resectable NSCLC, who have not received prior systemic treatment, including CPI, for advanced or metastatic disease. PD-L1 IHC Tumor Proportion Score (TPS) = 1% and < 50%. In Part 4, all patients with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.
- Refractory or relapsed to anti-PD-1 or anti-PD-L1, and anti-CTLA4 if applicable (NOTE: For all tumor types with checkpoint inhibitor approvals) with exception of the treatment naive NSCLC cohort.
- PD-L1 positivity by immunohistochemistry (IHC): Parts 1 and 3 (escalation cohorts) PD-L1 positivity is not required. Parts 2 and 4 (expansion cohorts): Combined Positive Score (CPS) or Tumor Proportion Score (TPS) above certain thresholds as defined per protocol.
- Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Treatment Sites in Georgia
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