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

  • STATUS
    Recruiting
  • End date
    Feb 22, 2024
  • participants needed
    248
  • sponsor
    Calico Life Sciences LLC
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Updated on 8 July 2022
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Summary

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.

Details
Condition Advanced Solid Tumor Cancer
Treatment Programmed Cell Death-1 (PD-1) Inhibitor, ABBV-CLS-484, Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Clinical Study IdentifierNCT04777994
SponsorCalico Life Sciences LLC
Last Modified on8 July 2022

Eligibility

 Yes No Not Sure

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
• Subjects with histologically or cytologically proven metastatic or locally advanced
tumors, for which no effective standard therapy exists, or where standard therapy has
failed. Subjects must have received at least 1 prior systemic anticancer therapy for the
indication being considered
For Monotherapy Dose Expansion only
Subjects 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
Relapsed/refractory HNSCC
Must have been previously treated with 1 or more prior lines of therapy in the locally
disease (for greater than 6 months); AND
Relapsed/refractory NSCLC
advanced or metastatic setting with the following tumor types
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
Subjects no recent history of hemorrhage, including hemoptysis, hematemesis, or melena
Subjects with poorly controlled hypertension are excluded

Exclusion Criteria

Unresolved Grade 2 or higher peripheral neuropathy
History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
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
History of uncontrolled, clinically significant endocrinopathy
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
History of solid organ transplant or allogeneic stem cell transplant
History of other malignancy, with the following exceptions
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
Adequately treated carcinoma in situ without evidence of disease
Recent history (within 6 months) of Childs-Pugh B or C classification of liver
History of interstitial lung disease or pneumonitis
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
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)
treatment and felt to be at low recurrence by investigator
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease
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
No known active disease present within ≥ 3 years before first dose of study
Clear my responses
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