Description:
The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone or
in combination with programmed cell death protein-1 (PD-1) inhibitors in treating solid
cancers.
ABBV-CLS-579 is an investigational drug being developed for the treatment of solid tumors.
The study has two arms - Monotherapy and Combination Therapy. In the monotherapy arm,
participants will receive ABBV-CLS-579 alone, in increasing doses. In the combination therapy
arm, escalating doses of ABBV-CLS-579 will be given in combination with a PD-1 inhibitor.
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 oral ABBV-CLS-579 capsule alone or in combination with intravenous
(IV) PD-1 inhibitor. Participants will receive study drug 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.
Title
- Brief Title: First In Human Study With ABBV-CLS-579 When Given Alone Or In Combination With Programmed Cell Death-1 Inhibitor In Participants With Locally Advanced Or Metastatic Tumors
- Official Title: A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-579 Alone and in Combination With Anti-PD-1 in Subjects With Locally Advanced or Metastatic Tumors
Clinical Trial IDs
- ORG STUDY ID:
M20-124
- SECONDARY ID:
2020-000639-28
- NCT ID:
NCT04417465
Conditions
- Advanced Solid Tumors Cancer
Interventions
Drug | Synonyms | Arms |
---|
ABBV-CLS-579 | | ABBV-CLS-579 And Programmed Cell Death-1 (PD-1) Inhibitor |
Programmed Cell Death-1 (PD-1) Inhibitor | | ABBV-CLS-579 And Programmed Cell Death-1 (PD-1) Inhibitor |
Purpose
The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone or
in combination with programmed cell death protein-1 (PD-1) inhibitors in treating solid
cancers.
ABBV-CLS-579 is an investigational drug being developed for the treatment of solid tumors.
The study has two arms - Monotherapy and Combination Therapy. In the monotherapy arm,
participants will receive ABBV-CLS-579 alone, in increasing doses. In the combination therapy
arm, escalating doses of ABBV-CLS-579 will be given in combination with a PD-1 inhibitor.
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 oral ABBV-CLS-579 capsule alone or in combination with intravenous
(IV) PD-1 inhibitor. Participants will receive study drug 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.
Trial Arms
Name | Type | Description | Interventions |
---|
ABBV-CLS-579 Monotherapy | Experimental | Participants will receive escalating doses of ABBV-CLS-579 | |
ABBV-CLS-579 And Programmed Cell Death-1 (PD-1) Inhibitor | Experimental | Participants will receive escalating doses of ABBV-CLS-579 and PD-1 inhibitor. | - ABBV-CLS-579
- Programmed Cell Death-1 (PD-1) Inhibitor
|
Eligibility Criteria
Inclusion Criteria:
- Must weigh at least 35 kilograms (kg).
- 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 anticancer therapy for the
indication being considered.
- 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 < 450 msec (using Fridericia's correction), and
no clinically significant electrocardiographic findings.
Exclusion Criteria:
- Untreated brain or meningeal metastases (participants 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.
- 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, cardiac arrythmia or peripheral artery
disease.
- 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 participation in
this study or would make the participant an unsuitable candidate to receive study
drug.
- History of uncontrolled, clinically significant endocrinopathy.
- 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
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579 |
Time Frame: | Baseline Up to Approximately Day 44 |
Safety Issue: | |
Description: | Maximum plasma/serum concentration of ABBV-CLS-579 |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 |
Time Frame: | Baseline through Study Completion (approximately 3 years) |
Safety Issue: | |
Description: | ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment |
Measure: | Objective Response Rate (ORR) Of ABBV-CLS-579 Monotherapy Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 |
Time Frame: | Baseline through Study Completion (approximately 3 years) |
Safety Issue: | |
Description: | ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment |
Measure: | Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1 |
Time Frame: | Baseline through Study Completion (approximately 3 years) |
Safety Issue: | |
Description: | BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence |
Measure: | Best Overall Response (BOR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On RECIST v1.1 |
Time Frame: | Baseline through Study Completion (approximately 3 years) |
Safety Issue: | |
Description: | BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence |
Measure: | Change from Baseline QTc |
Time Frame: | Baseline Up to Approximately Day 44 |
Safety Issue: | |
Description: | QT prolongation is measured by the QT interval measurement corrected for heart rate (QTc) change from baseline |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Calico Life Sciences LLC |
Trial Keywords
- Cancer
- Tumor
- ABBV-CLS-579
- anti-PD-1
Last Updated
June 24, 2021