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

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: Zimberelimab; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: AB598

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 in participants with advanced malignancies.

Enrollment: 87 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

• Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1.

• Monotherapy-specific criteria for dose escalation and PD cohorts:

  • Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor for which standard therapy has proven ineffective, intolerable, or is considered inappropriate.
  • Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy.

• Dose Expansion cohort criteria:

  • Histologically confirmed, documented diagnosis of 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 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)

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87 participants in 8 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

Pharmacodynamic Cohort 1

Experimental group

Description:

Participants will receive AB598 IV infusion once every 3 weeks

Treatment:

Drug: AB598

Pharmacodynamic Cohort 2

Experimental group

Description:

Participants will receive AB598 IV infusion once every 3 weeks

Treatment:

Drug: AB598

Pharmacodynamic Cohort 3

Experimental group

Description:

Participants will receive AB598 IV infusion once every 3 weeks

Treatment:

Drug: AB598

Dose Expansion Gastric/GEJ Cancer (phase 1b)

Experimental group

Description:

Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil)

Treatment:

Drug: AB598

Drug: Fluorouracil

Drug: Oxaliplatin

Drug: Leucovorin

Drug: Zimberelimab