Georgia's Online Cancer Information Center

Find A Clinical Trial

Study of INBRX-105 in Patients With Solid Tumors

Status
Active
Cancer Type
Lung Cancer
Melanoma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03809624
Protocol IDs
Ph 1 INBRX-105 (primary)
NCI-2019-02844
Study Sponsor
Inhibrx, Inc.

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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.