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Study of ABBV-CLS-484 for Advanced Solid Tumors

This study is testing a new drug called ABBV-CLS-484, both alone and in combination with other cancer treatments (a PD-1 inhibitor or a VEGFR tyrosine kinase inhibitor). The goal is to find a safe and effective dose for people with advanced solid tumors. Researchers will look at how the drug moves through your body, its effects, and if it helps shrink tumors. The study is enrolling 248 participants aged 18 and older who weigh at least 35 kg, have a good performance status (meaning you can perform daily tasks), and a life expectancy of at least 12 weeks. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 248 participants. It will be conducted in three parts: monotherapy dose escalation, combination dose escalation, and dose expansion.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints measure drug levels up to approximately Day 42 for monotherapy and Day 64 for combination therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04777994

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Calico Life Sciences LLC
~248 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:ABBV-CLS-484Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)Programmed Cell Death-1 (PD-1) Inhibitor

At a glance

Recruiting sites
28 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-484 (Monotherapy)
Measured over Baseline Up to Approximately Day 42
+17 more outcomes measured

Conditions

Advanced Solid Tumor Cancer

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Where it's being run

30 sites across 23 states
Texas3
Massachusetts2
North Carolina2
Pennsylvania2
Seoul Teugbyeolsi2
Madrid2
Arizona1
Connecticut1

Study leadership

  • Calico Life Sciences LLC · STUDY_DIRECTOR · Calico

Who to contact

Nicole Director Clinical Operations
[email protected]
650-754-6200
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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 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
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.

Exclusion

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)
Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
Unresolved Grade 2 or higher peripheral neuropathy.
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.
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.
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 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.
History of interstitial lung disease or pneumonitis.
Major surgery \<= 28 days prior to first dose of study drug
Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.

What this trial measures

  • Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-484 (Monotherapy)Baseline Up to Approximately Day 42

    Maximum plasma/serum concentration of ABBV-CLS-484

  • Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of Programmed Cell Death-1 (PD-1) Inhibitor (Combination therapy)Baseline Up to Approximately Day 64

    Maximum plasma/serum concentration of PD-1 inhibitor

  • Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFRTKI (Combination therapy) Maximum plasma/serum concentration of PD-1 inhibitorBaseline Up to Approximately Day 64

    Maximum plasma/serum concentration of PD-1 inhibitor

  • Dose Escalation: Time To Cmax (Tmax) Of ABBV-CLS-484 (Monotherapy)Baseline Up to Approximately Day 42

    The amount of time taken to reach Cmax

  • Dose Escalation: Time To Cmax (Tmax) Of PD-1 Inhibitor (Combination therapy)Baseline Up to Approximately Day 64

    The amount of time taken to reach Cmax

  • Dose Escalation Time to Cmax (Tmax) of VEGFR TKI (Combination therapy)Baseline Up to Approximately Day 64

    The amount of time taken to reach Cmax

  • Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of ABBV-CLS-484 (Monotherapy)Baseline Up to Approximately Day 42

    Terminal phase elimination half-life (t1/2)

  • Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of PD-1 Inhibitor (Combination therapy)Baseline Up to Approximately Day 64

    Terminal phase elimination half-life (t1/2)

  • Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of VEGFR TKI (Combination therapy)Baseline Up to Approximately Day 64

    Terminal phase elimination half-life (t1/2)

  • Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-484 (Monotherapy)Baseline Up to Approximately Day 42

    AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose

  • Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor (Combination therapy)Baseline Up to Approximately Day 64

    AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose

  • Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of VEGFR TKI (Combination therapy)Baseline Up to Approximately Day 64

    AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose

  • Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484Baseline Up to Approximately Day 42

    The MTD and/or RP2D of ABBV-CLS-484 will be determined during the monotherapy therapy dose escalation phase of the study

  • Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484 and a PD-1 Inhibitor (Combination therapy)Baseline Up to Approximately Day 64

    The MTD and/or RP2D of ABBV-CLS-484 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study

  • Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484 and a VEGFR TKI (Combination therapy)Baseline Up to Approximately Day 64

    The MTD and/or RP2D of ABBV-CLS-484 and VEGFR TKI will be determined during the combination therapy dose escalation phase of the study

  • Dose Expansion: Objective Response Rate (ORR) Of ABBV-CLS-484 Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Monotherapy)Baseline Up to Approximately Day 42

    ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment

  • Dose Expansion: Objective Response Rate (ORR) Of ABBV-CLS-484 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)Baseline Up to Approximately Day 64

    ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment

  • Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And VEGFR TKI Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)Baseline Up to Approximately Day 64

    ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment