Investigational Drug
Budigalimab
TrialFetch AI Analysis
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Overview
Budigalimab (ABBV-181; PR-1648817) is an investigational humanized IgG1 monoclonal antibody targeting programmed cell death protein 1 (PD-1). It has been studied as monotherapy and in combination regimens for advanced cancers, and at substantially lower doses as a potential immune-based intervention for HIV-1. (pmc.ncbi.nlm.nih.gov)
Mechanism of action
Budigalimab binds PD-1 and blocks its interaction with PD-L1 and PD-L2, relieving inhibitory signaling and potentially restoring T-cell activity. Its Fc region contains mutations intended to reduce Fc-receptor interactions and associated effector functions. Phase 1 pharmacodynamic studies found rapid, sustained PD-1 receptor saturation at the oncology doses evaluated. (pmc.ncbi.nlm.nih.gov)
Efficacy
In a phase 1 monotherapy expansion study, 81 checkpoint-inhibitor-naive patients received 250 mg every two weeks or 500 mg every four weeks:
- Head and neck squamous-cell carcinoma: confirmed objective response rate (ORR) was 13% among 40 evaluable patients; median response duration was 9.4 months and median progression-free survival (PFS) was 3.6 months.
- Non-small-cell lung cancer: confirmed ORR was 19% among 37 evaluable patients, including one complete response; median response duration was 10.1 months and median PFS was 1.9 months. (pmc.ncbi.nlm.nih.gov)
Earlier mixed-tumor dose-escalation and expansion cohorts reported four responses during dose escalation but none in the multihistology expansion cohort. (pmc.ncbi.nlm.nih.gov)
In a small randomized phase 1b HIV-1 study, six of 11 participants receiving four 10-mg doses every two weeks experienced delayed viral rebound and/or at least six weeks of low-level viral control during analytical treatment interruption. Two maintained HIV-1 RNA below 200 copies/mL without antiretroviral therapy through study end at 204 and 252 days. These exploratory findings are based on very small numbers and do not establish efficacy. (pmc.ncbi.nlm.nih.gov)
Safety
In the cancer expansion cohorts, investigator-attributed treatment-related adverse events occurred in 63% of patients with head and neck cancer and 58% with lung cancer. Common events included hypothyroidism, diarrhea, pruritus and fatigue. Grade 3 or higher treatment-related events occurred in 10% and 13%, respectively; no treatment-related deaths were reported. (pmc.ncbi.nlm.nih.gov)
In the 41-participant HIV study, most adverse events were grade 1–2. No grade 3 or higher treatment-related events, treatment-related serious events or deaths occurred. Two participants developed reversible grade 1 immune-related thyroid disorders. (pmc.ncbi.nlm.nih.gov)
Further reading
- First-in-human oncology study in NSCLC and head and neck cancer
- Phase 1 dose selection, pharmacokinetics and mixed-solid-tumor results
- Randomized phase 1b HIV-1 study
- NCI Drug Dictionary entry
Last updated: Sep 2026
Active trials using Budigalimab
Found 5 active trials using this drug:
TrialFetch AI summary: Adults with advanced squamous tumors who have progressed after standard therapy or cannot receive it are eligible; expansion cohorts focus on squamous non-small cell lung cancer and head and neck squamous cell carcinoma. Treatment is oral ABBV-711, an investigational PARP7 inhibitor, alone or with intravenous budigalimab, an anti-PD-1 antibody.
ClinicalTrials.gov ID: NCT07241039
TrialFetch AI summary: Adults with advanced or metastatic nonsquamous NSCLC are eligible; the randomized portion requires no prior systemic treatment for advanced disease and no known actionable genomic alterations, while dose escalation permits one prior regimen. Treatment combines telisotuzumab adizutecan, an investigational c-Met–targeted antibody–drug conjugate carrying a topoisomerase I inhibitor, with the investigational PD-1 antibody budigalimab; randomized comparators are budigalimab or pembrolizumab plus platinum/pemetrexed.
ClinicalTrials.gov ID: NCT06772623
TrialFetch AI summary: Adults with previously untreated metastatic nonsquamous NSCLC and no actionable genomic alteration receive platinum–pemetrexed chemotherapy followed by pemetrexed maintenance, combined with investigational livmoniplimab (which inhibits activation of TGF-β1) plus budigalimab (anti–PD-1), budigalimab alone in dose selection, or pembrolizumab (anti–PD-1).
ClinicalTrials.gov ID: NCT06236438
TrialFetch AI summary: Adults with previously untreated, unresectable, locally advanced or metastatic HCC (BCLC B/C), Child-Pugh A or B7 liver function, and ECOG 0–1 are randomized to livmoniplimab, which blocks activation of immunosuppressive TGF-β1 via the GARP–latent TGF-β1 complex, plus the anti–PD-1 antibody budigalimab, or an active control. Controls are atezolizumab/bevacizumab or tremelimumab/durvalumab during dose optimization, and tremelimumab/durvalumab in the subsequent efficacy comparison.
ClinicalTrials.gov ID: NCT06109272
TrialFetch AI summary: Adults with ECOG 0–1 and refractory advanced solid tumors are eligible for dose escalation; expansion focuses on unresectable or metastatic NSCLC or HNSCC previously treated with platinum chemotherapy and PD-1/PD-L1 blockade, excluding NSCLC with known EGFR mutations or ALK rearrangements. Patients receive intravenous ABBV-514, an investigational anti-CCR8 antibody designed to deplete tumor-infiltrating regulatory T cells, alone or with budigalimab, an investigational anti-PD-1 antibody.
ClinicalTrials.gov ID: NCT05005403
