Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers (ARC-25)

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Arcus Biosciences

Status and phase

Enrolling
Phase 1

Conditions

Advanced Malignancies
Triple Negative Breast Cancer (TNBC)
Esophageal Cancer
Non-Small Cell Lung Cancer (NSCLC)
Gastroesophageal-junction Cancer (GEJ)
Ovarian Cancer
Advanced Cancer
Bladder Cancer
Renal Cell Carcinoma (RCC)
Gastric Cancer
Head and Neck Squamous Cell Carcinoma (HNSCC)
Cervical Cancer

Treatments

Drug: AB598
Drug: Pemetrexed
Drug: Fluorouracil
Drug: Leucovorin
Drug: Carboplatin
Drug: Zimberelimab
Drug: Oxaliplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05891171
ARC-25

Details and patient eligibility

About

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.

Enrollment

81 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

81 participants in 6 patient groups

Dose Escalation Cohort 1
Experimental group
Description:
Participants will receive AB598 intravenous (IV) infusion once every 3 weeks
Treatment:
Drug: AB598
Dose Escalation Cohort 2
Experimental group
Description:
Participants will receive AB598 IV infusion once every 3 weeks
Treatment:
Drug: AB598
Dose Escalation Cohort 3
Experimental group
Description:
Participants will receive AB598 IV infusion once every 3 weeks
Treatment:
Drug: AB598
Dose Escalation Cohort 4
Experimental group
Description:
Participants will receive AB598 IV infusion once every 3 weeks
Treatment:
Drug: AB598
Dose Expansion Cohort 1 NSCLC
Experimental group
Description:
Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years
Treatment:
Drug: Carboplatin
Drug: Zimberelimab
Drug: Pemetrexed
Drug: AB598
Dose Expansion Cohort 2 Gastric/GEJ Cancer
Experimental group
Description:
Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab once every 4 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years
Treatment:
Drug: Oxaliplatin
Drug: Zimberelimab
Drug: Leucovorin
Drug: Fluorouracil
Drug: AB598

Trial contacts and locations

10

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Central trial contact

Medical Director

Data sourced from clinicaltrials.gov

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