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Testing ABBV-CLS-484 for advanced solid tumors

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

Phase 1 Interventional Calico Life Sciences LLC · NCT04777994

This study is testing a new treatment called ABBV-CLS-484 for people with advanced solid tumors that haven't improved with standard therapies to see how well it works on its own and with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment248 (estimated)
Ages18 Years and up
SexAll
SponsorCalico Life Sciences LLC Industry-sponsored
Locations30 sites (Tucson, Arizona and 29 other locations)
Trial IDNCT04777994 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ABBV-CLS-484, both as a standalone treatment and in combination with other therapies targeting PD-1 or VEGFR. The study is structured in three parts: the first part focuses on monotherapy dose escalation, the second part examines combination therapy dose escalation, and the third part involves dose expansion for both monotherapy and combination therapy. Participants with advanced solid tumors that have not responded to standard treatments will be enrolled to determine the optimal dosing and effectiveness of ABBV-CLS-484.

Who should consider this trial

Good fit: Ideal candidates include individuals with locally advanced or metastatic solid tumors who have previously received at least one systemic anticancer therapy.

Not a fit: Patients with tumors that have effective standard therapies available may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that currently have limited effective treatments.

How similar studies have performed: Other studies involving PD-1 inhibitors and targeted therapies have shown promising results, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Tucson, Arizona and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid Tumor CancerCancerTumoranti-PD-1ABBV-CLS-484clear cell renal cell carcinomahead and neck squamous cell carcinomanon-small cell lung cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.