A Phase 1 interventional study of INBRX-105 - PDL1x41BB antibody and Pembrolizumab in Metastatic Solid Tumors, Non-small Cell Lung Cancer and Melanoma, sponsored by Inhibrx Biosciences, Inc. Terminated at 23 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Inhibrx Biosciences, Inc · Phase 1, Interventional, and Treatment
This is a first-in-human, open-label, nonrandomized, four-part 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.
Exclusion Criteria:
INBRX-105 will be escalated in patients with locally advanced or metastatic solid tumors.
Drug: INBRX-105 - PDL1x41BB antibody
Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Drug: INBRX-105 - PDL1x41BB antibody
Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Drug: INBRX-105 - PDL1x41BB antibody
Patients with gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Drug: INBRX-105 - PDL1x41BB antibody
Patients with head and neck squamous cell carcinoma (NPC or OPC) will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Drug: INBRX-105 - PDL1x41BB antibody
INBRX-105 will be escalated in combination with Pembrolizumab in pateitns with locally advanced or metastatic solid tumors.
Drug: INBRX-105 - PDL1x41BB antibody · Drug: Pembrolizumab
CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.
Drug: INBRX-105 - PDL1x41BB antibody · Drug: Pembrolizumab
CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.
Drug: INBRX-105 - PDL1x41BB antibody · Drug: Pembrolizumab
CPI-relapsed/refractory patients with head and neck squamous cell carcinoma, gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with INBRX-105 in combination with Pembrolizumab.
Drug: INBRX-105 - PDL1x41BB antibody · Drug: Pembrolizumab
CPI naive patients (PD-L1 IHC between 1 and 49%) will be treated with INBRX-105 in combination with Pembrolizumab.
Drug: INBRX-105 - PDL1x41BB antibody · Drug: Pembrolizumab
CPI naive patients (PD-L1 IHC \>50%) will be treated with INBRX-105 in combination with Pembrolizumab.
Drug: INBRX-105 - PDL1x41BB antibody
The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Also known as: Keytruda
Frequency of adverse events of INBRX-105
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: Up to 2-3 years
Severity of adverse events of INBRX-105
Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time frame: Up to 2-3 years
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-105
The MTD and/or RP2D of INBRX-105 will be determined.
Time frame: Up to 2-3 years
Area under the serum concentration time curve (AUC) of INBRX-105
Area under the serum concentration time curve (AUC) of INBRX-105 will be determined.
Time frame: Up to 2-3 years
Maximum observed serum concentration (Cmax) of INBRX-105
Maximum observed serum concentration (Cmax) of INBRX-105 will be determined.
Time frame: Up to 2-3 years
Trough observed serum concentration (Ctrough) of INBRX-105
Trough observed serum concentration (Cmax) of INBRX-105 will be determined.
Time frame: Up to 2-3 years
Time to Cmax (Tmax) of INBRX-105
Time to Cmax (Tmax) of INBRX-105 will be determined.
Time frame: Up to 2-3 years
Immunogenicity of INBRX-105
Frequency of anti-drug antibodies (ADA) against INBRX-105 will be determined.
Time frame: Up to 2-3 years
Anti-tumor activity of INBRX-105
Tumor response will be determined by immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Time frame: Up to 2-3 years
Plan to share: No
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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Inhibrx Biosciences, Inc