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.
- Brief Title: Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors
- Official Title: A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
- NCT ID:
This is a Phase 1b open-label study to evaluate the safety and clinical activity of AB122 in
biomarker-selected participants with advanced solid tumors.
AB122 every 3 weeks (Q3W) will be evaluated in molecularly defined patient populations as
described by the StrataNGS test (to be performed outside of this study protocol).
Participants with any advanced tumor type will be stratified evenly by tumor biomarker status
as follows: TMB-H or Strata Immune Signature positive. Each cohort may enroll approximately
40 participants. Following completion of and/or discontinuation from investigational product
and follow-up, all participants will be followed for survival.
|TMB-H||Experimental||Participants with a tumor biomarker status of TMB-H will receive AB122 every 3 weeks.|
|Strata Immune Signature positive||Experimental||Participants with a tumor biomarker status Strata Immune Signature positive will receive AB122 every 3 weeks.|
1. Capable of giving signed informed consent.
2. Male or female participants ≥ 18 years of age at the time of screening.
3. 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).
4. Pathologically confirmed tumor that is metastatic, advanced, or recurrent with
progression for which no alternative or curative therapy exists. Tumors must be TMB-H
or Strata Immune Signature positive.
5. 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.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
7. 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.
8. 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
9. 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
10. 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
11. 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
12. Adequate organ and marrow function
1. Use of any live attenuated vaccines against infectious diseases within 4 weeks (28
days) of initiation of investigational product.
2. 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 AEs.
3. History of myocardial infarction within 6 months or history of arterial thromboembolic
event within 3 months of the first dose of investigational agent.
4. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
5. 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.
6. Any active or documented history of autoimmune disease or history of a syndrome that
required systemic steroids or immunosuppressive medications.
7. Any acute gastrointestinal symptoms at the time of screening or admission.
8. Prior malignancy active within the previous year except for locally curable cancers
that have been apparently cured.
9. Prior treatment with an anti-PD-L1, anti-PD-1, anti-CTLA-4, or other immune checkpoint
inhibitor or agonist as monotherapy or in combination.
10. Prior treatment with temozolomide.
11. 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
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|
Primary Outcome Measures
|Measure:||Objective response Rate (ORR)|
|Time Frame:||Change from baseline assessed at week 6, 12, 18 and then every 9 weeks thereafter until disease progression, approximately 12 months (however can be longer)|
|Description:||Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Tumor assessments over time will be measured using RECIST v1.1|
Secondary Outcome Measures
|Measure:||Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0|
|Time Frame:||From screening until 90 days after the last dose of investigational product or until initiation of a new systemic anticancer therapy, whichever occurs first.|
|Description:||Number of Participants Treated with AB122 with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0|
|Measure:||Duration of response (DoR)|
|Time Frame:||From the date of initiation of treatment until the date of first documented progression, through completion of the study, approximately 12 months (however may be longer)|
|Description:||The time from first documentation of disease response (CR or PR) until first documentation of progressive disease.|
|Measure:||Time to response (TTR)|
|Time Frame:||From the date of initiation of treatment until the date of first documented response, through completion of the study, approximately 12 months (however may be longer)|
|Description:||The time from treatment initiation to confirmed best overall response of CR or PR.|
|Measure:||Disease control rate at 6 months (DCR6)|
|Time Frame:||6 Months|
|Description:||Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1|
|Measure:||Progression-free survival at 6 (PFS6)|
|Time Frame:||6 Months|
|Description:||The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 6 months|
|Measure:||Progression-free survival at 12 months (PFS12)|
|Time Frame:||12 Months|
|Description:||The percentage of Participants Without Disease Progression per RECIST v1.1 and iRECIST at 12 months|
|Measure:||Overall survival at 12 months (OS12)|
|Time Frame:||12 Months|
|Description:||The percentage of participants who are alive at 12 months based on first dose to date of death.|
|Lead Sponsor:||Arcus Biosciences, Inc.|