Actively Recruiting
Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Led by Calico Life Sciences LLC · Updated on 2025-12-23
248
Participants Needed
30
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must weigh at least 35 kilograms (kg).
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Have a life expectancy of at least 12 weeks.
- Meet laboratory test criteria as defined in the protocol.
- Have a QT interval corrected for heart rate less than 470 msec without significant ECG abnormalities.
- Have measurable disease according to RECIST 1.1 criteria.
- For dose escalation: Have histologically or cytologically confirmed metastatic or locally advanced tumors with no effective standard therapy or failed standard therapy.
- Have received at least one prior systemic anticancer therapy for the tumor indication.
- For monotherapy dose expansion: Have received at least one prior PD-1/PD-L1 targeted therapy with best response of complete response, partial response, or stable disease.
- Have relapsed or refractory head and neck squamous cell carcinoma, non-small cell lung cancer, or advanced clear cell renal cell carcinoma.
- For PD-1 combination dose expansion: Have relapsed head and neck squamous cell carcinoma, non-small cell lung cancer, or advanced clear cell renal cell carcinoma with prior PD-1/PD-L1 therapy response.
- Have locally advanced or metastatic microsatellite instability-high tumors refractory to PD-1/PD-L1 therapy.
- For VEGFR TKI combination dose expansion: Have relapsed advanced clear cell renal cell carcinoma with no more than one prior VEGFR TKI.
- Have no recent history of bleeding such as hemoptysis, hematemesis, or melena.
- Have controlled blood pressure without poorly controlled hypertension.
You will not qualify if you...
- Have untreated brain or meningeal metastases or require ongoing steroid treatment for them.
- Have unresolved grade 2 or higher toxicities from previous cancer treatments, except alopecia.
- Have unresolved grade 2 or higher peripheral neuropathy.
- Have a history of hepatitis B, hepatitis C, or HIV infection.
- Have had congestive heart failure (NYHA Class 2 or higher), ischemic cardiovascular events, pericarditis, or significant pericardial effusion or arrhythmia within the past 6 months.
- Have liver disease classified as Child-Pugh B or C within the past 6 months.
- Have significant medical or psychiatric conditions that could interfere with study participation.
- Have uncontrolled significant endocrine disorders.
- Have gastrointestinal problems preventing oral medication absorption or inability to swallow capsules.
- Have previous pneumonitis, grade 3 or higher immune-related toxicity, hypersensitivity, or drug-related toxicity requiring stopping PD-1/PD-L1 or other immune-oncology treatments.
- Have active autoimmune disease requiring systemic treatment in the past 2 years (except certain endocrinopathies, vitiligo, or atopic conditions).
- Have a history of solid organ or allogeneic stem cell transplant.
- Have had another cancer within the past 3 years except adequately treated skin cancer or carcinoma in situ.
- Have a history of interstitial lung disease or pneumonitis.
- Have had major surgery within 28 days before starting study drug.
- Have active severe COVID-19 infection as per local testing guidelines.
AI-Screening
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Trial Site Locations
Total: 30 locations
1
University of Arizona Cancer Center - Tucson /ID# 262698
Tucson, Arizona, United States, 85724
Actively Recruiting
2
Yale University School of Medicine /ID# 225707
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Johns Hopkins Hospital /ID# 254056
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Beth Israel Deaconess Medical Center /ID# 252009
Boston, Massachusetts, United States, 02215-5400
Actively Recruiting
5
Dana-Farber Cancer Institute /ID# 249642
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869
New York, New York, United States, 10016
Actively Recruiting
8
Duke Cancer Center /ID# 251975
Durham, North Carolina, United States, 27710
Actively Recruiting
9
Carolina BioOncology Institute /ID# 225704
Huntersville, North Carolina, United States, 28078
Completed
10
Perelman Center for Advanced Medicine /ID# 250188
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
UPMC Hillman Cancer Ctr /ID# 225706
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705
Providence, Rhode Island, United States, 02903-4923
Actively Recruiting
13
University of Texas Southwestern Medical Center /ID# 251974
Dallas, Texas, United States, 75390-7208
Actively Recruiting
14
University of Texas MD Anderson Cancer Center /ID# 252004
Houston, Texas, United States, 77030
Actively Recruiting
15
NEXT Oncology /ID# 225708
San Antonio, Texas, United States, 78229
Completed
16
Institut Paoli-Calmettes /ID# 260956
Marseille, Bouches-du-Rhone, France, 13009
Actively Recruiting
17
IUCT Oncopole /ID# 252673
Toulouse, Occitanie, France, 31059
Actively Recruiting
18
Centre Antoine-Lacassagne /ID# 252606
Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
Actively Recruiting
19
Hopital Foch /ID# 252607
Suresnes, France, 92151
Actively Recruiting
20
Rabin Medical Center /ID# 263631
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
21
Hadassah Medical Center /ID# 252366
Jerusalem, Jerusalem, Israel, 91120
Actively Recruiting
22
The Chaim Sheba Medical Center /ID# 226756
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
23
National Cancer Center Hospital /ID# 225884
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
24
Wakayama Medical University Hospital /ID# 252988
Wakayama, Wakayama, Japan, 641-8510
Actively Recruiting
25
Seoul National University Hospital /ID# 254635
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
26
Samsung Medical Center /ID# 260664
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
27
Yonsei University Health System Severance Hospital /ID# 260665
Seoul, South Korea, 03722
Actively Recruiting
28
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
29
Hospital Universitario 12 de Octubre /ID# 257374
Madrid, Madrid, Spain, 28041
Actively Recruiting
30
Hospital Universitario HM Sanchinarro /ID# 228034
Madrid, Madrid, Spain, 28050
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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