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
    100
  • sponsor
    Calico Life Sciences LLC
Updated on 19 June 2021

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. 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 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 agent in subjects with locally advanced or metastatic, relapsed or refractory gastric or GEJ adenocarcinoma.

Details
Condition Advanced Solid Tumor Cancer
Treatment Programmed Cell Death-1 (PD-1) Inhibitor, ABBV-CLS-484
Clinical Study IdentifierNCT04777994
SponsorCalico Life Sciences LLC
Last Modified on19 June 2021

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 1 prior line containing PD-1/PD-L1 targeted therapy with a best response of CR/PR/stable disease by RECIST v1.1 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 Combination Dose Expansion only
Subjects with gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS 1)
Must not have received a PD-1/PD-L1 targeting agent, or other immune-oncology agents as part of a prior line of therapy
Must have received, and progressed on, at least 2 prior lines of chemotherapy in the locally advanced or metastatic setting; . If tumor is HER2/neu positive, subject must have received prior treatment with an approved HER2 targeting therapy

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 for 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
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