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DRUG:

budigalimab (ABBV-181)

i
Other names: ABBV-181, ABBV 181, ABBV181
Company:
AbbVie
Drug class:
PD1 inhibitor
Related drugs:
1m
New P2 trial
|
gemcitabine • paclitaxel • docetaxel • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
2ms
Trial termination
|
5-fluorouracil • oxaliplatin • irinotecan • budigalimab (ABBV-181) • leucovorin calcium • giloralimab (ABBV-927)
2ms
Enrollment closed • Adverse events • Combination therapy • Checkpoint inhibition • Metastases
|
sorafenib • Lenvima (lenvatinib) • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
2ms
Trial completion date • Trial primary completion date • Adverse events
|
CD4 (CD4 Molecule)
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budigalimab (ABBV-181)
2ms
Enrollment open • Adverse events • Combination therapy • Checkpoint inhibition • Metastases
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
3ms
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
carboplatin • albumin-bound paclitaxel • budigalimab (ABBV-181) • giloralimab (ABBV-927) • revdofilimab (ABBV-368)
4ms
Combination treatment with TTX-030, a first-in-class anti-CD39 antibody, in patients with advanced pancreatic cancer (ESMO 2024)
HLA-DQ is an HLA class II molecule expressed on APCs. Patients were enrolled May 2020 to Feb 2022 and treated with standard dosing of G/nP (d1, 8, 15) and either TTX-030 40mg/kg followed by 20mg/kg every two weeks (n = 31) or TTX-030 every 2 weeks and budigalimab (anti-PD1 Ab) 500mg every 4 weeks (n = 28). TTX-030 combinations show promising clinical activity in 1L PDAC with HLA-DQhigh having marked benefit. A randomized phase 2 study (NCT06119217) is underway to further evaluate TTX-030 combination treatment based on HLA-DQ status in metastatic PDAC.
Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
|
ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
|
nCounter® PanCancer Immune Profiling Panel
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budigalimab (ABBV-181) • TTX-030
5ms
New P1 trial • Adverse events • Combination therapy • Checkpoint inhibition • Metastases
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
5ms
A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=163, Active, not recruiting, AbbVie | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date • Metastases
|
budigalimab (ABBV-181) • giloralimab (ABBV-927)
6ms
Trial completion date • Trial primary 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)
7ms
Trial 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
7ms
Trial completion • Phase classification • Adverse events • Combination therapy • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • budigalimab (ABBV-181) • leucovorin calcium • giloralimab (ABBV-927)
7ms
Trial completion date • Adverse events
|
CD4 (CD4 Molecule)
|
budigalimab (ABBV-181)
7ms
Trial primary completion date • Combination therapy • Metastases
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
7ms
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
8ms
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
8ms
Enrollment open • Adverse events • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
8ms
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
8ms
Trial completion date • Combination therapy • Metastases
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
9ms
New P2/3 trial • Adverse events • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
9ms
Trial completion
|
SEZ6 (Seizure Related 6 Homolog)
|
budigalimab (ABBV-181) • ABBV-011
11ms
Enrollment open • Phase classification • Adverse events • Combination therapy • Metastases
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab) • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
1year
New P2 trial • Metastases
|
gemcitabine • albumin-bound paclitaxel • budigalimab (ABBV-181) • TTX-030
1year
New P2 trial • Adverse events • Combination therapy • Metastases
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab) • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
1year
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
over1year
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
over1year
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
over1year
Trial completion date • Trial primary completion date • Adverse events • Combination therapy • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • budigalimab (ABBV-181) • leucovorin calcium • giloralimab (ABBV-927)
over1year
Enrollment closed • Enrollment change • Combination therapy
|
budigalimab (ABBV-181) • ABBV-011
almost2years
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)
almost2years
Enrollment open • Adverse events • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • IDH wild-type
|
cisplatin • carboplatin • budigalimab (ABBV-181) • ABBV-706
2years
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
2years
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)
over2years
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)
over2years
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)
over2years
Trial completion
|
PD-L1 (Programmed death ligand 1)
|
budigalimab (ABBV-181) • revdofilimab (ABBV-368)
over2years
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)
over2years
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