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DRUG:

budigalimab (ABBV-181)

i
Other names: ABBV-181, ABBV 181, ABBV181
Company:
AbbVie
Drug class:
PD1 inhibitor
Related drugs:
6d
Trial completion date • Adverse events
|
CD4 (CD4 Molecule)
|
budigalimab (ABBV-181)
8d
Trial primary completion date • Combination therapy • Metastases
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
17d
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers (clinicaltrials.gov)
P1, N=185, Completed, Trishula Therapeutics, Inc. | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • gemcitabine • docetaxel • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • budigalimab (ABBV-181) • leucovorin calcium • TTX-030
24d
Trial completion date • Trial primary completion date • Adverse events • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • SEZ6 (Seizure Related 6 Homolog)
|
EGFR mutation • IDH wild-type • SEZ6 expression
|
cisplatin • carboplatin • budigalimab (ABBV-181) • ABBV-706
1m
Enrollment open • Adverse events • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
1m
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients (clinicaltrials.gov)
P2, N=180, Recruiting, Trishula Therapeutics, Inc. | Not yet recruiting --> Recruiting | Initiation date: Dec 2023 --> Mar 2024
Enrollment open • Trial initiation date • Metastases
|
gemcitabine • albumin-bound paclitaxel • budigalimab (ABBV-181) • TTX-030
1m
Trial completion date • Combination therapy • Metastases
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
2ms
New P2/3 trial • Adverse events • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
3ms
Trial completion
|
SEZ6 (Seizure Related 6 Homolog)
|
budigalimab (ABBV-181) • ABBV-011
4ms
Enrollment open • Phase classification • Adverse events • Combination therapy • Metastases
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab) • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
6ms
New P2 trial • Metastases
|
gemcitabine • albumin-bound paclitaxel • budigalimab (ABBV-181) • TTX-030
6ms
New P2 trial • Adverse events • Combination therapy • Metastases
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab) • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
6ms
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
9ms
Phase I study of ABBV-706, an anti-SEZ6 antibody-drug conjugate, alone or in combination in adults with advanced solid tumors (ESMO 2023)
The study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and antitumor activity of ABBV-706 as monotherapy and in combination with budigalimab (a PD-1 inhibitor), carboplatin, or cisplatin, and determine the recommended phase 2 dose (RP2D) of ABBV-706. Tumor tissue submission for retrospective SEZ6 expression analysis is required. The study began in December 2022 and enrollment is ongoing.
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
|
SEZ6 (Seizure Related 6 Homolog)
|
SEZ6 expression
|
cisplatin • carboplatin • budigalimab (ABBV-181) • ABBV-706
9ms
First-in-human study of ABBV-514 as monotherapy and in combination with budigalimab in patients with advanced solid tumors (ESMO 2023)
In dose expansion, patients with R/R non-small cell lung cancer will be enrolled in ABBV-514 monotherapy (N=12) and ABBV-514 + BDG (N=12) cohorts, and patients with R/R head and neck squamous cell carcinoma in an ABBV-514 + BDG (N=12) cohort. Enrollment initiated in November 2021, with 30 patients enrolled as of April 2023.
Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CCR8 (C-C Motif Chemokine Receptor 8)
|
budigalimab (ABBV-181) • ABBV-514
10ms
Trial completion date • Trial primary completion date • Adverse events • Combination therapy • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • budigalimab (ABBV-181) • leucovorin calcium • giloralimab (ABBV-927)
11ms
Enrollment closed • Enrollment change • Combination therapy
|
budigalimab (ABBV-181) • ABBV-011
1year
Enrollment closed • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • PD-L1 negative
|
carboplatin • albumin-bound paclitaxel • budigalimab (ABBV-181) • giloralimab (ABBV-927) • revdofilimab (ABBV-368)
over1year
Enrollment open • Adverse events • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • IDH wild-type
|
cisplatin • carboplatin • budigalimab (ABBV-181) • ABBV-706
over1year
New P1 trial • Adverse events • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • IDH wild-type
|
cisplatin • carboplatin • budigalimab (ABBV-181) • ABBV-706
over1year
Trial completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • PD-L1 negative
|
carboplatin • albumin-bound paclitaxel • budigalimab (ABBV-181) • giloralimab (ABBV-927) • revdofilimab (ABBV-368)
almost2years
Circulating L-Arginine predicts the survival of cancer patients treated with immune checkpoint inhibitors. (PubMed, Ann Oncol)
We demonstrate that baseline ARG levels predict ICI response. Plasma ARG quantification may therefore represent an attractive biomarker to tailor novel therapeutic regimens targeting the ARG pathway in combination with ICIs.
Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
budigalimab (ABBV-181)
almost2years
Trial completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • PD-L1 negative
|
carboplatin • albumin-bound paclitaxel • budigalimab (ABBV-181) • giloralimab (ABBV-927) • revdofilimab (ABBV-368)
almost2years
Trial completion
|
PD-L1 (Programmed death ligand 1)
|
budigalimab (ABBV-181) • revdofilimab (ABBV-368)
2years
A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=182, Completed, AbbVie | Active, not recruiting --> Completed
Trial completion • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Venclexta (venetoclax) • budigalimab (ABBV-181) • Rova-T (rovalpituzumab tesirine)
2years
Safety and efficacy of TTX-030, an anti-CD39 antibody, in combination with chemoimmunotherapy for the first line treatment of locally advanced or metastatic gastric/GEJ cancer (AACR 2022)
The addition of nivolumab to chemotherapy has recently become the standard of care of 1st‑line (1L) treatment of locally advanced or metastatic (LA/M) gastric cancer but further improvements are needed. An expansion cohort of Study TTX‑030‑002 (ongoing, US and South Korea) is evaluating the safety and efficacy of the combination of TTX-030, budigalimab (anti-PD-1) and FOLFOX for the 1L treatment of patients (pts) with LA/M HER2− gastric/GEJ adenocarcinoma... Preliminary results indicate that the combination of TTX-030, budigalimab and FOLFOX exhibited promising efficacy as 1L treatment of LA/M gastric/GEJ cancer regardless of CPS status and has a manageable safety profile without evidence of excessive toxicities. To our knowledge, this represents the first report of an anti-CD39 antibody in combination with chemo-immunotherapy in gastric cancer. Updated clinical and biomarker data will be included in the final presentation.
Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
|
Opdivo (nivolumab) • 5-fluorouracil • budigalimab (ABBV-181) • leucovorin calcium • TTX-030
2years
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=170, Active, not recruiting, AbbVie | Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Sep 2021 --> Feb 2022
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
budigalimab (ABBV-181) • revdofilimab (ABBV-368)
over2years
Association of Baseline and Pharmacodynamic Biomarkers With Outcomes in Patients Treated With the PD-1 Inhibitor Budigalimab. (PubMed, J Immunother)
Univariate analysis demonstrated an association between prolonged progression-free survival and higher tumor mutational burden/neoantigen load, smaller tumor size, lower platelet-lymphocyte ratios, lower CCL23, lower colony-stimulating factor 1, and lower interleukin-6 levels at baseline. The biomarker analysis presented herein identified additional early pharmacodynamic biomarkers associated with anti-PD-1 activity and improved clinical responses to budigalimab in patients with advanced HNSCC and NSCLC.
Clinical • PK/PD data • Journal • Tumor Mutational Burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CSF1 (Colony stimulating factor 1)
|
PD-L1 expression • IL6-L
|
budigalimab (ABBV-181)
over2years
Enrollment open • Adverse events • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • budigalimab (ABBV-181) • ABBV-514
over2years
Clinical • Enrollment change • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
over2years
Clinical • Trial completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • ER negative • PGR negative
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
over2years
Clinical • New P1 trial • Adverse events • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • budigalimab (ABBV-181) • ABBV-514
over2years
Safety, pharmacokinetics, and efficacy of budigalimab with rovalpituzumab tesirine in patients with small cell lung cancer. (PubMed, Cancer Treat Res Commun)
Combination therapy with budigalimab and Rova-T had promising efficacy and appeared to be tolerated in patients with SCLC. Although Rova-T development has been discontinued, development of budigalimab combined with other anticancer agents is ongoing.
Clinical • PK/PD data • Journal • PD(L)-1 Biomarker • IO biomarker
|
DLL3 (Delta Like Canonical Notch Ligand 3)
|
DLL3 expression
|
budigalimab (ABBV-181) • Rova-T (rovalpituzumab tesirine)
almost3years
First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma. (PubMed, Cancer Immunol Immunother)
The safety, efficacy and biomarker profiles of budigalimab are similar to other PD-1 inhibitors. Development of budigalimab in combination with novel anticancer agents is ongoing.
Clinical • P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
|
PD-L1 expression
|
budigalimab (ABBV-181)
almost3years
A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=182, Active, not recruiting, AbbVie | Trial completion date: Mar 2021 --> May 2022 | Trial primary completion date: Mar 2021 --> May 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Venclexta (venetoclax) • budigalimab (ABBV-181) • Rova-T (rovalpituzumab tesirine)
over3years
Clinical • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • PD-L1 negative
|
carboplatin • albumin-bound paclitaxel • budigalimab (ABBV-181) • giloralimab (ABBV-927) • revdofilimab (ABBV-368)
over3years
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=140, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | Trial completion date: Jan 2021 --> Sep 2021 | Trial primary completion date: Jan 2021 --> Sep 2021
Clinical • Enrollment closed • Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
budigalimab (ABBV-181) • revdofilimab (ABBV-368)
over3years
A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=221, Recruiting, AbbVie | Trial primary completion date: Sep 2021 --> Dec 2021
Clinical • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Venclexta (venetoclax) • budigalimab (ABBV-181) • Rova-T (rovalpituzumab tesirine)
almost4years
Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
TGFB1 (Transforming Growth Factor Beta 1)
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)