Clinical Trials List
Protocol NumberM20-124
NCT Number(ClinicalTrials.gov Identfier)NCT04417465
2020-08-01 - 2025-07-01
Phase I
Not yet recruiting1
Recruiting3
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
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Trial Applicant
AbbVie
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Sponsor
Calico Life Sciences LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Jih-Hsiang Lee 無
- 徐偉勛 無
- Wei-Wu Chen 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Tsai-Sheng Yang 無
- Ming-Mo Hou 無
- See-Tong Pang 無
- I-hung Shao 無
- 沈鼎文 無
- Yung-Chang Lin 無
- Chi-Ting Liau 無
- 黃文冠 無
- Kai-Jie Yu 無
- Yuan-Cheng Chu 無
- Jen-Shi Chen 無
- Hung-Chih Hsu 無
- 張境夫 無
- PO-HUNG LIN 無
- 黃亮鋼 無
- Hung-Ming Wang 無
- Wen-Chi Chou 無
- Yung-Chia Kao 無
- Hong-Cheng Gan 無
- 吳俊德 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 賴建豪 無
- Shau-Hsuan Li 無
- 陳友木 無
- 李易濰 無
- 王逸熙 無
- Tai-Jan Chiu 無
- 張育平 無
- 張晃智 無
- Chia-Cheng Tseng 無
- Yu-Li Su 無
- 趙東瀛 無
- 林孟志 無
- 黃國棟 無
- 鍾聿修 無
- 林理涵 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Min Yeh 無
- Wen-Pin Su 無
- 劉奕廷 無
- 顏志傑 無
- Shang-Yin Wu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Locally Advanced or Metastatic Tumors
Objectives
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.
Test Drug
ABBV-CLS-579
Active Ingredient
ABBV-CLS-579
Dosage Form
N/A
Dosage
N/A
Endpoints
Primary Outcome Measures :
Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
Maximum plasma/serum concentration of ABBV-CLS-579
Maximum Observed Plasma/Serum Concentration (Cmax) Of Metabolite M4 Maximum Observed Plasma/Serum Concentration (Cmax) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
Maximum plasma/serum concentration of Metabolite M4
Maximum Observed Plasma/Serum Concentration (Cmax) Of Programmed Cell Death-1 (PD-1) Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
Maximum plasma/serum concentration of PD-1 inhibitor
Time To Cmax (Tmax) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
The amount of time taken to reach Cmax
Time To Cmax (Tmax) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
The amount of time taken to reach Cmax
Time To Cmax (Tmax) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
The amount of time taken to reach Cmax
Terminal Phase Elimination Rate Constant (β) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Constant (β) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Constant (β) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Half-Life (t1/2) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
Terminal phase elimination half-life (t1/2)
Terminal Phase Elimination Rate Half-Life (t1/2) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
Terminal phase elimination half-life (t1/2)
Terminal Phase Elimination Rate Half-Life (t1/2) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
Terminal phase elimination half-life (t1/2)
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-579 [ Time Frame: Baseline through Study Completion (approximately 3 years) ]
The MTD and/or RP2D of ABBV-CLS-579 will be determined during the monotherapy dose escalation phase of the study
Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-579 and a PD-1 Inhibitor [ Time Frame: Baseline through Study Completion (approximately 3 years) ]
The MTD and/or RP2D of ABBV-CLS-579 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
Maximum plasma/serum concentration of ABBV-CLS-579
Maximum Observed Plasma/Serum Concentration (Cmax) Of Metabolite M4 Maximum Observed Plasma/Serum Concentration (Cmax) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
Maximum plasma/serum concentration of Metabolite M4
Maximum Observed Plasma/Serum Concentration (Cmax) Of Programmed Cell Death-1 (PD-1) Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
Maximum plasma/serum concentration of PD-1 inhibitor
Time To Cmax (Tmax) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
The amount of time taken to reach Cmax
Time To Cmax (Tmax) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
The amount of time taken to reach Cmax
Time To Cmax (Tmax) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
The amount of time taken to reach Cmax
Terminal Phase Elimination Rate Constant (β) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Constant (β) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Constant (β) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Half-Life (t1/2) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
Terminal phase elimination half-life (t1/2)
Terminal Phase Elimination Rate Half-Life (t1/2) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
Terminal phase elimination half-life (t1/2)
Terminal Phase Elimination Rate Half-Life (t1/2) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
Terminal phase elimination half-life (t1/2)
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579 [ Time Frame: Baseline Up to Approximately Day 44 ]
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of Metabolite M4 [ Time Frame: Baseline Up to Approximately Day 44 ]
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor [ Time Frame: Baseline Up to Approximately Day 64 ]
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-579 [ Time Frame: Baseline through Study Completion (approximately 3 years) ]
The MTD and/or RP2D of ABBV-CLS-579 will be determined during the monotherapy dose escalation phase of the study
Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-579 and a PD-1 Inhibitor [ Time Frame: Baseline through Study Completion (approximately 3 years) ]
The MTD and/or RP2D of ABBV-CLS-579 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Inclution 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.
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
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.
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.
The Estimated Number of Participants
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Taiwan
28 participants
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Global
280 participants
