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RECRUITING
NCT04777994
PHASE1

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

Sponsor: Calico Life Sciences LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2021-03-09

Completion Date

2026-10

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

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

Locations (30)

University of Arizona Cancer Center - Tucson /ID# 262698

Tucson, Arizona, United States

Yale University School of Medicine /ID# 225707

New Haven, Connecticut, United States

Johns Hopkins Hospital /ID# 254056

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center /ID# 252009

Boston, Massachusetts, United States

Dana-Farber Cancer Institute /ID# 249642

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010

Ann Arbor, Michigan, United States

NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869

New York, New York, United States

Duke Cancer Center /ID# 251975

Durham, North Carolina, United States

Carolina BioOncology Institute /ID# 225704

Huntersville, North Carolina, United States

Perelman Center for Advanced Medicine /ID# 250188

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Ctr /ID# 225706

Pittsburgh, Pennsylvania, United States

Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center /ID# 251974

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center /ID# 252004

Houston, Texas, United States

NEXT Oncology /ID# 225708

San Antonio, Texas, United States

Institut Paoli-Calmettes /ID# 260956

Marseille, Bouches-du-Rhone, France

IUCT Oncopole /ID# 252673

Toulouse, Occitanie, France

Centre Antoine-Lacassagne /ID# 252606

Nice, Provence-Alpes-Côte d'Azur Region, France

Hopital Foch /ID# 252607

Suresnes, France

Rabin Medical Center /ID# 263631

Petah Tikva, Central District, Israel

Hadassah Medical Center /ID# 252366

Jerusalem, Jerusalem, Israel

The Chaim Sheba Medical Center /ID# 226756

Ramat Gan, Tel Aviv, Israel

National Cancer Center Hospital /ID# 225884

Chuo-ku, Tokyo, Japan

Wakayama Medical University Hospital /ID# 252988

Wakayama, Wakayama, Japan

Seoul National University Hospital /ID# 254635

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 260664

Seoul, Seoul Teugbyeolsi, South Korea

Yonsei University Health System Severance Hospital /ID# 260665

Seoul, South Korea

Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario 12 de Octubre /ID# 257374

Madrid, Madrid, Spain

Hospital Universitario HM Sanchinarro /ID# 228034

Madrid, Madrid, Spain