NCT04777994

Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors

A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Calico Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will assess the safety, PK, PD, and preliminary efficacy of ABBVCLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial aims to establish a safe, tolerable, and efficacious dose of ABBVCLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy). Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.

Conditions

• Advanced Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	ABBV-CLS-484	Oral Capsule
DRUG	Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)	Oral Tablet
DRUG	Programmed Cell Death-1 (PD-1) Inhibitor	Intravenous (IV) infusion

Timeline

• Start date: 2021-03-09
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2021-03-02
• Last updated: 2025-12-23

Locations

30 sites across 6 countries: United States, France, Israel, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study