Fact CheckerSign in

NCT04777994RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-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 ABBV-CLS-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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
248 (estimated)
First submitted
25 Feb 2021
Start date
9 Mar 2021
Primary completion date
31 Oct 2026
Lead sponsor
Calico Life Sciences LLC
NCT number
NCT04777994
EU CT number
2023-507568-38-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 248
  • From 9 Mar 2021 to the primary completion date, 31 Oct 2026
  • 30 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
  • If treated with a PD-1/aPD-L1 targeting or other immune-oncology agents in the past, excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation.
  • Major surgery \<= 28 days prior to first dose of study drug

Other illness

  • Untreated brain or meningeal metastases (i.e., subjects with history of metastases are eligible provided they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 28 days after definitive therapy)
  • History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis, or clinically significant pericardial effusion or arrythmia.
  • Recent history (within 6 months) of Childs-Pugh B or C classification of liver disease.
  • History of clinically significant medical and/or psychiatric conditions or any other reason that, in the opinion of the investigator, would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
  • History of uncontrolled, clinically significant endocrinopathy.
  • Known gastrointestinal disorders making absorption of oral medications problematic; subject must be able to swallow capsules.
  • Active autoimmune disease requiring systemic treatment in past 2-years (exceptions for endocrinopathies, vitiligo or atopic conditions).
  • History of solid organ transplant or allogeneic stem cell transplant.
  • History of interstitial lung disease or pneumonitis.
  • Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.

Age

  • History of other malignancy, with the following exceptions:
    • No known active disease present within \>= 3 years before first dose of study treatment and felt to be at low recurrence by investigator.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated carcinoma in situ without evidence of disease.

Other

  • Unresolved Grade 2 or higher peripheral neuropathy.

Who the study is looking for

  • Must weigh at least 35 kilograms (kg).
  • An Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
  • Life expectancy of \>= 12 weeks.
  • Laboratory values meeting protocol criteria.
  • QT interval corrected for heart rate \< 470 msec (using Fridericia's correction), and no clinically significant electrocardiographic findings.
  • Measurable disease defined by RECIST 1.1 criteria.
    • For Monotherapy and Combination Dose Escalation:
  • Participants with histologically or cytologically proven metastatic or locally advanced tumors, for which no effective standard therapy exists, or where standard therapy has failed. Participants must have received at least 1 prior systemic anticancer therapy for the indication being considered.
    • For Monotherapy Dose Expansion only:
  • Participants must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy with a best response by RECIST v1.1 of CR/PR/stable (any duration) or stable disease (for greater than 6 months); AND
  • Must have been previously treated with 1 or more prior lines of therapy in the locally advanced or metastatic setting with the following tumor types:
    • Relapsed/refractory HNSCC
    • Relapsed/refractory NSCLC
    • Advanced ccRCC
    • For PD-1 Targeting Agent Combination Dose Expansion only:
  • For the following tumor types, subject must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy with response by RECIST v1.1 of CR/PR (any duration) or stable disease (for greater than 6 months):
    • Relapsed HNSCC
    • Relapsed NSCLC
    • Relapsed Advanced ccRCC
  • For the following tumor types, subject must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy and have had disease progression with PD-1/PD-L1 targeted therapy:
    • Locally Advanced or metastatic MSI-H tumors
    • For VEGFR TKI Combination Dose Expansion only:
  • Relapsed advance ccRCC with no more than 1 prior VEGFR TKI
  • Participants no recent history of hemorrhage, including hemoptysis, hematemesis, or melena
  • Participants with poorly controlled hypertension are excluded.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario 12 de Octubre /ID# 257374
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario HM Sanchinarro /ID# 228034
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Institut Paoli-Calmettes /ID# 260956
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Centre Antoine-Lacassagne /ID# 252606
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Hopital Foch /ID# 252607
Coordinator of this site? Confirm its status
SuresnesFranceRecruiting
IUCT Oncopole /ID# 252673
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Hadassah Medical Center /ID# 252366
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Rabin Medical Center /ID# 263631
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
The Chaim Sheba Medical Center /ID# 226756
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
National Cancer Center Hospital /ID# 225884
Coordinator of this site? Confirm its status
Chuo-kuJapanRecruiting
Wakayama Medical University Hospital /ID# 252988
Coordinator of this site? Confirm its status
WakayamaJapanRecruiting
Samsung Medical Center /ID# 260664
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Yonsei University Health System Severance Hospital /ID# 260665
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital /ID# 254635
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
Johns Hopkins Hospital /ID# 254056
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Beth Israel Deaconess Medical Center /ID# 252009
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Dana-Farber Cancer Institute /ID# 249642
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of Texas Southwestern Medical Center /ID# 251974
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Duke Cancer Center /ID# 251975
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
University of Texas MD Anderson Cancer Center /ID# 252004
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Carolina BioOncology Institute /ID# 225704
Coordinator of this site? Confirm its status
HuntersvilleUnited StatesCompleted
Yale University School of Medicine /ID# 225707
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Perelman Center for Advanced Medicine /ID# 250188
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
UPMC Hillman Cancer Ctr /ID# 225706
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705
Coordinator of this site? Confirm its status
ProvidenceUnited StatesRecruiting
NEXT Oncology /ID# 225708
Coordinator of this site? Confirm its status
San AntonioUnited StatesCompleted
University of Arizona Cancer Center - Tucson /ID# 262698
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.