First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors

  • End date
    Sep 30, 2023
  • participants needed
  • sponsor
    Calico Life Sciences LLC
Updated on 4 October 2022


The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone and in combination with a PD-1 target agent or with a VEGF TKI.

ABBV-CLS-579 is an investigational drug being developed for the treatment of tumors.

The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-579 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 Combination Dose Expansion.

Part 1, ABBV-CLS-579 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.

Part 2, ABBV-CLS-579 will be administered at escalating dose levels in combination with a PD-1 targeting agent to eligible subjects who have advanced solid tumors.

Part 3, ABBV-CLS-579 will be administered at the determined recommended dose in combination with a PD-1 target agent or with a VEGFR TKI 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).

Adult participants with a diagnosis of some solid tumors for which no effective standard therapy exists or has failed will be enrolled. Participants will receive study treatment until disease progresses or discontinued.

There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Condition Advanced Solid Tumors Cancer
Treatment PD-1 Inhibitor, ABBV-CLS-579, Programmed Cell Death-1 (PD-1) Inhibitor, VEGFR TKI
Clinical Study IdentifierNCT04417465
SponsorCalico Life Sciences LLC
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Must weigh at least 35 kilograms (kg)
For Monotherapy and Combination Dose Escalation
An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Histologically or cytologically proven metastatic or locally advanced tumors (with measurable disease defined by Response Evaluation Criteria In Solid Tumors [RECIST] v1.1), 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
Life expectancy of ≥ 12 weeks
For Combination Dose Expansion
For the following tumor types, the subject must have received at least 1 prior line containing PD-1/PD-L1 target therapy
Laboratory values meeting protocol criteria
Indication with outcome of Prior PD-1/PD-L1 Targeted Therapy and other disease
Relapsed: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved
Agilent PD-L1 IHC 22C3 pharmDx kit
Refractory: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved
Agilent PD-L1 IHC 22C3 pharmDx kit
Relapsed or Refractory: Advanced disease (locally advanced or metastatic)
MSI-H tumors
Refractory: Locally advanced or metastatic MSI-H tumors whose tumors are
determined to have a MSI-H status by PCR or NGS tests, or dMMR by IHC tests
Relapsed or Refractory: Tumors express PD-L1 (CPS ≥ 1] as determined by the FDA
approved PD-L1 Agilent IHC 22C3 pharmDx kit
For Combination Dose Expansion
Locally advanced or metastatic, advanced ccRCC who have relapsed after at least 1
prior VEGFR TKI therapy
Received at least 1 prior line containing PD 1/PD L1 targeted therapy with a best
response by RECIST v1.1 of CR/PR (any duration) or stable disease (for greater than 6
Received at least 1 prior line containing PD-1/PD-L1 targeted therapy and have had
disease progression (in the absence of best response of CR/PR/stable disease by RECIST
v1.1) with PD 1/PD L1 targeted therapy
If the subject is on anticoagulant therapy, INR must be within therapeutic goal
QT interval corrected for heart rate < 450 msec (using Fridericia's correction), and
no clinically significant electrocardiographic findings

Exclusion Criteria

History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
History of uncontrolled, clinically significant endocrinopathy
History of solid organ transplant or allogeneic stem cell transplant
History of other malignancy, with the following exceptions
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
Untreated brain or meningeal metastases (participants with history of metastases are
eligible provide 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
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, cardiac arrythmia or peripheral artery
Recent history (within 6 months) of Childs-Pugh B or C classification of liver
History of clinically significant medical and/or psychiatric conditions or any other
reason that, in the opinion of the investigator, would interfere with participation in
this study or would make the participant an unsuitable candidate to receive study
Known gastrointestinal disorders making absorption of oral medications problematic
Inability to swallow capsules
If treated with anti-programmed cell death protein-1 (aPD-1)/antiprogrammed cell death
protein-ligand 1(aPD-L1) targeting or other immunostimulatory 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
Active autoimmune disease requiring systemic treatment in past 2-years (exceptions for
endocrinopathies, vitiligo or atopic conditions)
Poorly controlled hypertension
History of hemorrhage, including hemoptysis, hematemesis, or melena
No known active disease present for 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
Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
per local testing practices
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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