A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants with Advanced Malignancies
primary:
To assess the safety and tolerability of AB598 in patients with advanced malignancies
secondary:
To describe the PK profile of AB598 in patients with advanced malignancies
To assess the immunogenicity to AB598 in patients with advanced malignancies
To assess the preliminary clinical activity of AB598 in patients with advanced malignancies
AB598
PEMETREXED
FOLFOX
AB122 (Zimberelimab)
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.