Clinical trial · Interventional
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Non-small-cell-lung-cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Triple-Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-181 | Drug | — | UNRESOLVED |
| ABBV-368 | Drug | — | UNRESOLVED |
| ABBV-927 | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors
- description
- Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.
- interventionNames
- Drug: ABBV-927
- Drug: ABBV-368
- type
- EXPERIMENTAL
- label
- Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
- description
- Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.
- interventionNames
- Drug: ABBV-927
- Drug: ABBV-368
- Drug: ABBV-181
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Dose-Escalation: * Arm A: Participants with an advanced solid tumor who have progressed on standard therapies known to provide clinical benefit and/or participants who have refused or are intolerant of such therapy. * Arm B (non-small-cell-lung-cancer \[NSCLC\]): Participants with histologically or cytologically confirmed NSCLC who previously progressed during or after an anti-programmed cell death (PD)-1 or PD ligand 1 (PD-L1) therapy and a platinum-based regimen in the recurrent or metastatic setting. Dose-Expansion: * Arm 1, 2, and 3 (triple-negative breast cancer \[TNBC\]): Participants with histologically or cytologically confirmed breast adenocarcinoma that is estrogen receptor/progesterone receptor/human epidermal growth factor receptor (HER)2-negative who must have disease progression during or after at least 1 systemic therapy that included a taxane in the metastatic or recurrent setting and who are treatment-naïve to immunotherapy. * Arm 4 (TNBC): Participants with histologically or cytologically confirmed TNBC who have received no previous anti-cancer therapy for TNBC, and who are PD-L1 negative on tumor tissue by immunohistochemistry (IHC) assay. * Arm 5 (NSCLC): Participants with histologically or cytologically confirmed NSCLC who previously progressed either during or after an anti-PD-1 or PD-L1 therapy and a platinum-based regimen in the recurrent or metastatic setting. Exclusion Criteria: * Has history of inflammatory bowel disease or pneumonitis. * Has uncontrolled metastases to the central nervous system. * Has a concurrent malignancy that is clinically significant, treatment is required, or the participant is not clinically stable. * Has had a major surgery ≤ 28 days prior to the first dose of study drug or the surgical wound is not fully healed. * Has previously treated with an anti-PD- or PD-L1-targeting agent and had during the course of their therapy: * any immune-mediated toxicity of Grade 3 or worse severity * treatment of the toxicity with systemic corticosteroids * any hypersensitivity to the PD-1 or PD-L1-targeting agent * any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent
References
Publications (0)
Data not yet available