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ARC-20NCT05536141

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

The 50 most recent of 54 versions: 33 with changes below, 17 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 7 words Show 5 more changesShow less
    • Enrollment increased: 362 → 512 participants
    • Interventions modified
    • Trial arms changed: 15 → 18
    • Secondary endpoints: 4 to 14
    • Collaborators expanded, about 5 words
  2. Eligibility criteria expanded, about 12 words
  3. Site details revised at 2 of 25 sitesv49
  4. Trial sites reduced: 29 → 25 locationsv47
  5. Primary and study completion dates: Jul 2027 to Mar 2029v44 Show 4 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Enrollment target: 302 to 362
    • Interventions: Cabozantinib (Drug), Zimberelimab (Drug), casdatifan (Drug) to Cabozantinib (Drug), Ipilimumab (Drug), Zimberelimab (Drug), casdatifan (Drug)
    • Study arms: 13 to 15
Show 28 earlier versionsHide 28 earlier versions
  1. Study sites: 28 to 29v43
  2. Study sites: 27 to 28v42
  3. Study sites: 28 to 27v41
  4. Study sites: 23 to 28v35
  5. Study sites: 28 to 23v34
  6. Study sites: 26 to 28v30
  7. Site details revised at 1 of 26 sitesv29
  8. Study sites: 27 to 26v28
  9. Primary and study completion dates: Jan 2026 to Jul 2027
    • Eligibility criteria shortened, about 53 words
    • Interventions: Cabozantinib (Drug), casdatifan (Drug) to Cabozantinib (Drug), Zimberelimab (Drug), casdatifan (Drug)
    • Study arms: 9 to 13
    v27
  10. Study sites: 26 to 27v26
  11. Study sites: 23 to 26v24
  12. Study sites: 21 to 23v23
  13. Eligibility criteria revised
    • Interventions: AB521 (Drug), Cabozantinib (Drug) to Cabozantinib (Drug), casdatifan (Drug)
    • Secondary endpoints revised (4)
    v22
  14. Study sites: 19 to 21v21
  15. Study sites: 17 to 19v20
  16. Enrollment target: 146 to 302v19 Show 4 more changesShow less
    • Eligibility criteria expanded, about 30 words
    • Interventions: AB521 (Drug) to AB521 (Drug), Cabozantinib (Drug)
    • Study arms: 7 to 9
    • Study title expanded, about 4 words
  17. Study sites revised (17)v16
  18. Study sites: 15 to 17v15
  19. Study sites: 13 to 15v14
  20. Study sites: 12 to 13v13
  21. Enrollment target: 86 to 146
    • Eligibility criteria shortened, about 36 words
    • Study arms: 5 to 7
    v12
  22. Study sites: 10 to 12v11
  23. Study sites: 9 to 10v10
  24. Study sites revised (9)v9
  25. Study sites: 7 to 9v8
  26. Study sites: 5 to 7v7
  27. Eligibility criteria revised
    • Primary endpoints revised (2)
    • Study arms: 4 to 5
    v6
  28. Study sites: 3 to 5v5
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of participants with dose limiting toxicities (DLTs)
Timeframe: Up to 4 months
Number of participants with adverse events (AEs)
Timeframe: Up to 4 months

Secondary (14)

Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Plasma concentration of casdatifan
Area under the plasma concentration time curve (AUC) of casdatifan
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Duration of Response as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Show 9 moreShow less
Progression-free survival as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Overall survival
Area under the plasma concentration time curve (AUC) of casdatifan in combination with tivozanib
Maximum Observed Plasma Concentration (Cmax) of casdatifan in combination with tivozanib
Area under the plasma concentration time curve (AUC) of casdatifan in combination with ivonescimab
Maximum Observed Plasma Concentration (Cmax) of casdatifan in combination with ivonescimab
Percentage of patients who are ADA-positive and ADA-negative against ivonescimab
Area under the plasma concentration time curve (AUC) of casdatifan in combination with zimberelimab and axitinib
Maximum Observed Plasma Concentration (Cmax) of casdatifan in combination with zimberelimab and axitinib

Arms and interventions

Dose Escalation Cohort 1Experimental

Participants will receive casdatifan orally once daily

Dose Escalation Cohort 2Experimental

Participants will receive casdatifan orally once daily

Dose Escalation Cohort 3Experimental

Participants will receive casdatifan orally twice daily

Dose Escalation Cohort 4Experimental

Participants will receive casdatifan orally once daily

Dose Escalation Cohort 5Experimental

Participants will receive casdatifan orally once daily

Dose Expansion Cohort 1Experimental

Participants will receive casdatifan orally

Dose Expansion Cohort 2Experimental

Participants will receive casdatifan orally

Dose Expansion Cohort 3Experimental

Participants will receive casdatifan orally

Dose Expansion Cohort 4Experimental

Participants will receive casdatifan orally with with cabozantinib orally

Dose Expansion Cohort 5Experimental

Participants will receive casdatifan orally

Dose Expansion Cohort 6Experimental

Participants will receive casdatifan orally

Dose Expansion Cohort 7Experimental

Participants will receive casdatifan orally with zimberelimab infusion

Dose Expansion Cohort 8Experimental

Participants will receive casdatifan orally

Dose Expansion Cohort 9Experimental

Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion

Dose Expansion Cohort 10Experimental

Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion

Dose Expansion Cohort 11Experimental

Participants will receive casdatifan orally with tivozanib orally or tivozanib orally only.

Dose Expansion Cohort 12Experimental

Participants will receive casdatifan orally with ivonescimab infusion.

Dose Expansion Cohort 13Experimental

Participants will receive casdatifan orally with zimberelimab infusion and axitinib orally.

Drugs: Casdatifan, Cabozantinib, Zimberelimab, Ipilimumab, Tivozanib, Ivonescimab, Axitinib

Sites

25 sites in 4 countries

United States 20, Australia 3, South Korea 1, Spain 1