A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors (ARC-20)

Arcus Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors; Clear Cell Renal Cell Carcinoma

Treatments: Drug: Zimberelimab; Drug: casdatifan; Drug: Cabozantinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05536141

2024-519142-70-00 (EU Trial (CTIS) Number)

ARC-20

Details and patient eligibility

About

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 in participants with ccRCC in the dose expansion stage

Enrollment: 302 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Must have at least one measurable lesion per RECIST guidance

• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1

• Disease-specific criteria for dose escalation:

  • Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
  • Creatinine clearance ≥ 40 mL/min

Disease-specific criteria for dose-expansion:

• Histologically confirmed ccRCC
• Creatinine clearance ≥ 40 mL/min

Key Exclusion Criteria:

• Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
• Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous
• History of trauma or major surgery within 28 days prior to the first dose of investigational product
• For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

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)

---

302 participants in 13 patient groups

Dose Escalation Cohort 1

Experimental group

Description:

Participants will receive casdatifan orally once daily

Treatment:

Drug: casdatifan

Dose Escalation Cohort 2

Experimental group

Description:

Participants will receive casdatifan orally once daily

Treatment:

Drug: casdatifan

Dose Escalation Cohort 3

Experimental group

Description:

Participants will receive casdatifan orally twice daily

Treatment:

Drug: casdatifan

Dose Escalation Cohort 4

Experimental group

Description:

Participants will receive casdatifan orally once daily

Treatment:

Drug: casdatifan

Dose Escalation Cohort 5

Experimental group

Description:

Participants will receive casdatifan orally once daily

Treatment:

Drug: casdatifan

Dose Expansion Cohort 1

Experimental group

Description:

Participants will receive casdatifan orally

Treatment:

Drug: casdatifan

Dose Expansion Cohort 2

Experimental group

Description:

Participants will receive casdatifan orally

Treatment:

Drug: casdatifan

Dose Expansion Cohort 3

Experimental group

Description:

Participants will receive casdatifan orally

Treatment:

Drug: casdatifan

Dose Expansion Cohort 4

Experimental group

Description:

Participants will receive casdatifan orally with with cabozantinib orally

Treatment:

Drug: Cabozantinib

Drug: casdatifan

Dose Expansion Cohort 5

Experimental group

Description:

Participants will receive casdatifan orally

Treatment:

Drug: casdatifan

Dose Expansion Cohort 6

Experimental group

Description:

Participants will receive casdatifan orally

Treatment:

Drug: casdatifan

Dose Expansion Cohort 7

Experimental group

Description:

Participants will receive casdatifan orally with zimberelimab infusion

Treatment:

Drug: casdatifan

Drug: Zimberelimab

Dose Expansion Cohort 8

Experimental group

Description:

Participants will receive casdatifan orally

Treatment:

Drug: casdatifan