Clinical trial · Interventional
Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors
A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors
NCT04087018CI-TRIAL-00080853completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a Phase 1b open-label study to evaluate the safety and clinical activity of zimberelimab (AB122) in biomarker-selected participants with advanced solid tumors.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| zimberelimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TMB-H
- description
- Participants with a tumor biomarker status of TMB-H will receive zimberelimab every 3 weeks.
- interventionNames
- Drug: zimberelimab
- type
- EXPERIMENTAL
- label
- Strata Immune Signature positive
- description
- Participants with a tumor biomarker status Strata Immune Signature positive will receive zimberelimab every 3 weeks.
- interventionNames
- Drug: zimberelimab
Primary outcomes (1)
- measure
- Objective response Rate (ORR)
- timeFrame
- Approximately 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Capable of giving signed informed consent. * Male or female participants ≥ 18 years of age at the time of screening. * Negative serum pregnancy test at screening and negative serum or urine pregnancy test every 3 months during the treatment period (women of childbearing potential only). * Pathologically confirmed tumor that is metastatic, advanced, or recurrent with progression for which no alternative known to improve survival or curative therapy exists. Tumors must be TMB-H or Strata Immune Signature positive. * Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Prior chemotherapy or certain immune therapies or biologic agents must have been completed at least 4 weeks (28 days) before investigational product administration and all AEs have either returned to baseline or stabilized. * Previously treated brain or meningeal metastases with no evidence of progression by magnetic resonance imaging (MRI) for at least 4 weeks (28 days) prior to the first dose. * Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \> 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids \< 10 mg/day of prednisone or its equivalent may be permitted * Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before investigational product administration * Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative ribonucleic acid \[RNA; qualitative\]), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening * Adequate organ and marrow function Exclusion Criteria: * Use of any live attenuated vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product. * Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous or obscure the interpretation of toxicity determination or Adverse events (AEs). * History of myocardial infarction within 6 months or history of arterial thromboembolic event within 3 months of the first dose of investigational agent. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 90 days after the last dose of investigational product. * Any active or documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications. * Any acute gastrointestinal symptoms at the time of screening or admission. * Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured. * Prior treatment with an anti-PD-L1 or anti-PD-1 as monotherapy or in combination. * Prior treatment with temozolomide. * Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before investigational product administration.
References
Publications (0)
Data not yet available
No reference posted for this study.