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

Conditions

• Clear Cell Renal Cell Carcinoma
• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• casdatifan — DRUG
  Administered as specified in the treatment arm
• Cabozantinib — DRUG
  Administered as specified in the treatment arm
• Zimberelimab — DRUG
  Administered as specified in the treatment arm
• Ipilimumab — DRUG
  Administered as specified in the treatment arm

Study Details

The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Key Dates

Start date

Oct 26, 2022

Status verified

Apr 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

362 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation Cohort 1
  Participants will receive casdatifan orally once daily
• Experimental: Dose Escalation Cohort 2
  Participants will receive casdatifan orally once daily
• Experimental: Dose Escalation Cohort 3
  Participants will receive casdatifan orally twice daily
• Experimental: Dose Escalation Cohort 4
  Participants will receive casdatifan orally once daily
• Experimental: Dose Escalation Cohort 5
  Participants will receive casdatifan orally once daily
• Experimental: Dose Expansion Cohort 1
  Participants will receive casdatifan orally
• Experimental: Dose Expansion Cohort 2
  Participants will receive casdatifan orally
• Experimental: Dose Expansion Cohort 3
  Participants will receive casdatifan orally
• Experimental: Dose Expansion Cohort 4
  Participants will receive casdatifan orally with with cabozantinib orally
• Experimental: Dose Expansion Cohort 5
  Participants will receive casdatifan orally
• Experimental: Dose Expansion Cohort 6
  Participants will receive casdatifan orally
• Experimental: Dose Expansion Cohort 7
  Participants will receive casdatifan orally with zimberelimab infusion
• Experimental: Dose Expansion Cohort 8
  Participants will receive casdatifan orally
• Experimental: Dose Expansion Cohort 9
  Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
• Experimental: Dose Expansion Cohort 10
  Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 4 months ]

Central Contacts

• Medical Director
  +1-510-462-3330
  [email protected]

Locations (20)

Find similar trials in Birmingham, AL

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