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ARC-25NCT05891171

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 42 versions: 26 with changes below, 16 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 14 → 19 locations
  2. Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 6 entries
  3. Primary and study completion pushed from Mar 2026 to Sep 2027
    • Study sites: 15 to 14
    v37
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 87 to confirmed 40
    • Study sites: 20 to 15
    v29
  5. Study sites: 14 to 20v27
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 20 to 14v26
  2. Study sites: 19 to 20v23
  3. Eligibility criteria expanded, about 23 words
    • Secondary endpoints revised (6)
    v22
  4. Study sites: 18 to 19v21
  5. Study sites: 14 to 18v20
  6. Primary and study completion dates: Aug 2025 to Mar 2026v18 Show 5 more changesShow less
    • Enrollment target: 81 to 87
    • Interventions: AB598 (Drug), Carboplatin (Drug), Fluorouracil (Drug), Leucovorin (Drug), Oxaliplatin (Drug), Pemetrexed (Drug), Zimberelimab (Drug) to AB598 (Drug), Fluorouracil (Drug), Leucovorin (Drug), Oxaliplatin (Drug), Zimberelimab (Drug)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Study arms: 6 to 8
  7. Study sites: 10 to 14v17
  8. Study sites: 9 to 10v15
  9. Study sites: 7 to 9v14
  10. Study sites: 6 to 7v13
  11. Eligibility criteria expanded, about 4 wordsv12
  12. Study sites: 5 to 6v11
  13. Study sites: 4 to 5v10
  14. Study sites: 3 to 4v9
  15. Primary and study completion dates: Nov 2025 to Aug 2025
    • Start date changed from estimate of Oct 2023 to Oct 13, 2023
    v8
  16. Study sites: 1 to 3
    • Start date: Sep 2023 to Oct 2023
    v7
  17. Start date: Aug 2023 to Sep 2023v6
  18. Study site revisedv4
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Jul 2023 to Aug 2023
    v3
  20. Start date: Jun 30, 2023 to Jul 2023v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 2 years
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Timeframe: Up to 2 years

Secondary (6)

Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma
Maximum Concentration (Cmax) in Whole Blood and Plasma
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Objective Response Rate (ORR)
Show 1 moreShow less
Dose Expansion Cohort: Duration of Response (DOR)

Arms and interventions

Dose Escalation Cohort 1Experimental

Participants will receive AB598 intravenous (IV) infusion once every 3 weeks

Dose Escalation Cohort 2Experimental

Participants will receive AB598 IV infusion once every 3 weeks

Dose Escalation Cohort 3Experimental

Participants will receive AB598 IV infusion once every 3 weeks

Dose Escalation Cohort 4Experimental

Participants will receive AB598 IV infusion once every 3 weeks

Pharmacodynamic Cohort 1Experimental

Participants will receive AB598 IV infusion once every 3 weeks

Pharmacodynamic Cohort 2Experimental

Participants will receive AB598 IV infusion once every 3 weeks

Pharmacodynamic Cohort 3Experimental

Participants will receive AB598 IV infusion once every 3 weeks

Dose Expansion Gastric/GEJ Cancer (phase 1b)Experimental

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

Drugs: AB598, Zimberelimab, Fluorouracil, Leucovorin, Oxaliplatin

Sites

19 sites in 3 countries

United States 14, Taiwan 4, Australia 1