Trial Title:
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
NCT ID:
NCT05891171
Condition:
Advanced Cancer
Advanced Malignancies
Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Gastroesophageal-junction Cancer (GEJ)
Head and Neck Squamous Cell Carcinoma (HNSCC)
Non-Small Cell Lung Cancer (NSCLC)
Ovarian Cancer
Renal Cell Carcinoma (RCC)
Triple Negative Breast Cancer (TNBC)
Conditions: Official terms:
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Leucovorin
Carboplatin
Oxaliplatin
Fluorouracil
Pemetrexed
Conditions: Keywords:
AB598
AB122
Zimberelimab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AB598
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Escalation Cohort 1
Arm group label:
Dose Escalation Cohort 2
Arm group label:
Dose Escalation Cohort 3
Arm group label:
Dose Escalation Cohort 4
Arm group label:
Dose Expansion Cohort 1 NSCLC
Arm group label:
Dose Expansion Cohort 2 Gastric/GEJ Cancer
Intervention type:
Drug
Intervention name:
Zimberelimab
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 1 NSCLC
Arm group label:
Dose Expansion Cohort 2 Gastric/GEJ Cancer
Other name:
AB122
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 1 NSCLC
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 1 NSCLC
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 2 Gastric/GEJ Cancer
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 2 Gastric/GEJ Cancer
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Administered as specified in the treatment arm
Arm group label:
Dose Expansion Cohort 2 Gastric/GEJ Cancer
Summary:
The primary purpose of this study is to assess the safety and tolerability of AB598 when
taken alone, and in combination with zimberelimab and standard chemotherapy in
participants with advanced malignancies.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid
Tumors (RECIST) guidance
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Monotherapy-specific criteria for dose escalation cohorts:
- Participants may have any pathologically confirmed advanced or metastatic solid
tumor malignancy for which standard therapy has proven ineffective,
intolerable, or considered inappropriate
- Disease-specific criteria for dose-expansion Cohort 1 (NSCLC):
- Histologically confirmed, documented diagnosis of locally advanced unresectable
or metastatic non-squamous NSCLC
- Treatment-naive in the unresectable locally advanced or metastatic setting
- Cannot have progressed within 6 months of prior platinum-based chemotherapy for
earlier stage disease
- Mixed small-cell lung cancer histology is not permitted
- Disease-specific criteria for dose expansion Cohort 2 (Gastric/GEJ):
- Histologically confirmed, documented diagnosis of human epidermal growth factor
2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ
adenocarcinoma
- No prior systemic treatment for locally advanced unresectable or metastatic
disease
- Cannot have progressed within 6 months of prior platinum-based chemotherapy for
earlier stage disease
Key Exclusion Criteria:
- Use of any live vaccines against infectious diseases (eg, influenza, varicella)
within 4 weeks (28 days) of initiation of study
- Underlying medical conditions or AEs that, in the investigator's or sponsor's
opinion, will make the administration of the study drugs hazardous
- Any active or documented history of autoimmune disease including but not limited to
inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome,
systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis,
within 3 years of the first dose of study treatment
- History of trauma or major surgery within 28 days prior to the first dose of study
drug
- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment, or anticipation of need for systemic
immunosuppressant medication during study treatment with certain protocol specified
exceptions
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lake City Cancer Care, LLC.
Address:
City:
Lake City
Zip:
32024
Country:
United States
Status:
Recruiting
Facility:
Name:
Affinity Health-Hope and Healing Cancer Services, LLC
Address:
City:
Hinsdale
Zip:
60521
Country:
United States
Status:
Recruiting
Facility:
Name:
Goshen Center for Cancer Care
Address:
City:
Goshen
Zip:
46526
Country:
United States
Status:
Recruiting
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Gabrail Cancer Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology Dallas
Address:
City:
Dallas
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Start date:
October 13, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Arcus Biosciences, Inc.
Agency class:
Industry
Source:
Arcus Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891171
