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DRUG:

enristomig (INBRX-105)

i
Other names: INBRX 105, INBRX-105, ES-101, INBRX105, ES101, ES 101
Associations
Company:
Elpiscience, Inhibrx Biosci
Drug class:
CD137 agonist, PD-L1 antagonist
Associations
2ms
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov)
P1, N=160, Terminated, Inhibrx Biosciences, Inc | Trial completion date: Dec 2025 --> Oct 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Oct 2024; Program terminated due to lack of meaningful efficacy signal.
Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
|
TMB (Tumor Mutational Burden)
|
TMB-H
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)
4ms
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov)
P1, N=160, Active, not recruiting, Inhibrx Biosciences, Inc | Phase classification: P2 --> P1 | N=300 --> 160
Phase classification • Enrollment change • Combination therapy • Metastases
|
TMB (Tumor Mutational Burden)
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)
5ms
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer (clinicaltrials.gov)
P2, N=300, Active, not recruiting, Inhibrx Biosciences, Inc | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
|
TMB (Tumor Mutational Burden)
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)
over1year
Phase classification • Combination therapy • Metastases
|
TMB (Tumor Mutational Burden)
|
TMB-H
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)
almost2years
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors (clinicaltrials.gov)
P1, N=300, Recruiting, Inhibrx, Inc. | N=170 --> 300 | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
TMB (Tumor Mutational Burden)
|
TMB-H
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)
over2years
A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=22, Terminated, Elpiscience Biopharma, Ltd. | N=180 --> 22 | Recruiting --> Terminated | Trial primary completion date: Nov 2021 --> Apr 2022; Sponsor's clinical development strategy adjustment
Enrollment change • Trial termination • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
enristomig (INBRX-105)
over2years
A Study of ES101 (PD-L1x4-1BB Bispecific Antibody) in Patients With Advanced Malignant Thoracic Tumors (clinicaltrials.gov)
P1b/2, N=0, Withdrawn, Elpiscience Biopharma, Ltd. | N=276 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • ALK rearrangement
|
enristomig (INBRX-105)
almost3years
Study of INBRX-105 in Patients With Solid Tumors (clinicaltrials.gov)
P1, N=170, Recruiting, Inhibrx, Inc. | Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Nov 2022 --> Aug 2023
Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)
3years
Key pharmacokinetic and pharmacodynamic parameters that correlate with the anti-tumor activity of a bispecific PD-L1 conditional 4-1BB agonist (SITC 2021)
Early efforts to develop 4-1BB targeted agonists were limited by poor tolerability (Urelumab) or insufficient efficacy (Utomilumab). INBRX-105 is currently being evaluated in patients with advanced solid tumors in a first-in-human trial (NCT03809624). Trial Registration INBRX-105 is currently being evaluated in patients with advanced solid tumors in a first-in-human trial (NCT03809624).
PK/PD data • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
|
PD-L1 expression
|
utomilumab (PF-05082566) • enristomig (INBRX-105) • urelumab (BMS-663513)
over3years
Study of INBRX-105 in Patients With Solid Tumors (clinicaltrials.gov)
P1, N=170, Recruiting, Inhibrx, Inc. | N=90 --> 170 | Trial completion date: Dec 2021 --> Mar 2023 | Trial primary completion date: Jul 2021 --> Nov 2022
Clinical • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK rearrangement
|
Keytruda (pembrolizumab) • enristomig (INBRX-105)