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

Primary Purpose

Advanced Solid Tumor Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-CLS-484
Programmed Cell Death-1 (PD-1) Inhibitor
Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Sponsored by
Calico Life Sciences LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor Cancer focused on measuring Cancer, Tumor, anti-PD-1, ABBV-CLS-484, clear cell renal cell carcinoma (ccRCC), head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), relapsed or refractory (R/R), Microsatellite instability - high tumors (MSI-H), Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 disease (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 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:

  • 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 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.
    • 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.

Sites / Locations

  • Yale UniversityRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • Carolina BioOncology InstituteRecruiting
  • UPMC Hillman Cancer CenterRecruiting
  • Lifespan Cancer Institute at Rhode Island HospitalRecruiting
  • Next OncologyRecruiting
  • IUCT OncopoleRecruiting
  • Hadassah Medical CenterRecruiting
  • The Chaim Sheba Medical CenterRecruiting
  • Wakayama Medical University HospitalRecruiting
  • National Cancer Center HospitalRecruiting
  • Hospital Universitario HM SanchinarroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Monotherapy Dose Escalation

Combination Dose Escalation with PD-1 Inhibitor

Monotherapy Expansion

Combination Expansion with PD-1 Inhibitor

Combination Dose Escalation with VEGFR TKI

Combination Expansion

Arm Description

ABBV-CLS-484 will be administered as a monotherapy in subjects with solid tumors

ABBV-CLS-484 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors

ABBV-CLS-484 will be administered 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 be administered at the determined recommended dose in combination with Programmed Cell Death-1 Inhibitor in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.

ABBV-CLS-484 will be administered in combination with a Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) in subjects with solid tumors

ABBV-CLS-484 will be administered at the determined recommended dose in combination with VEGFR TKI in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.

Outcomes

Primary Outcome Measures

Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-484 (Monotherapy)
Maximum plasma/serum concentration of ABBV-CLS-484
Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of Programmed Cell Death-1 (PD-1) Inhibitor (Combination therapy)
Maximum plasma/serum concentration of PD-1 inhibitor
Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFRTKI (Combination therapy) Maximum plasma/serum concentration of PD-1 inhibitor
Maximum plasma/serum concentration of PD-1 inhibitor
Dose Escalation: Time To Cmax (Tmax) Of ABBV-CLS-484 (Monotherapy)
The amount of time taken to reach Cmax
Dose Escalation: Time To Cmax (Tmax) Of PD-1 Inhibitor (Combination therapy)
The amount of time taken to reach Cmax
Dose Escalation Time to Cmax (Tmax) of VEGFR TKI (Combination therapy)
The amount of time taken to reach Cmax
Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of ABBV-CLS-484 (Monotherapy)
Terminal phase elimination half-life (t1/2)
Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of PD-1 Inhibitor (Combination therapy)
Terminal phase elimination half-life (t1/2)
Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of VEGFR TKI (Combination therapy)
Terminal phase elimination half-life (t1/2)
Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-484 (Monotherapy)
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor (Combination therapy)
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of VEGFR TKI (Combination therapy)
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484
The MTD and/or RP2D of ABBV-CLS-484 will be determined during the monotherapy therapy dose escalation phase of the study
Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484 and a PD-1 Inhibitor (Combination therapy)
The MTD and/or RP2D of ABBV-CLS-484 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484 and a VEGFR TKI (Combination therapy)
The MTD and/or RP2D of ABBV-CLS-484 and VEGFR TKI will be determined during the combination therapy dose escalation phase of the study
Dose Expansion: Objective Response Rate (ORR) Of ABBV-CLS-484 Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Monotherapy)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Dose Expansion: Objective Response Rate (ORR) Of ABBV-CLS-484 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And VEGFR TKI Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment

Secondary Outcome Measures

Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 Based On (RECIST) v1.1 (Monotherapy)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And VEGFR TKI Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment

Full Information

First Posted
February 25, 2021
Last Updated
July 19, 2023
Sponsor
Calico Life Sciences LLC
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04777994
Brief Title
A Phase 1 Study With ABBV-CLS-484 in Subjects With Locally Advanced or Metastatic Tumors
Official Title
A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
February 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calico Life Sciences LLC
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor Cancer
Keywords
Cancer, Tumor, anti-PD-1, ABBV-CLS-484, clear cell renal cell carcinoma (ccRCC), head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), relapsed or refractory (R/R), Microsatellite instability - high tumors (MSI-H), Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy Dose Escalation
Arm Type
Experimental
Arm Description
ABBV-CLS-484 will be administered as a monotherapy in subjects with solid tumors
Arm Title
Combination Dose Escalation with PD-1 Inhibitor
Arm Type
Experimental
Arm Description
ABBV-CLS-484 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors
Arm Title
Monotherapy Expansion
Arm Type
Experimental
Arm Description
ABBV-CLS-484 will be administered 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)
Arm Title
Combination Expansion with PD-1 Inhibitor
Arm Type
Experimental
Arm Description
ABBV-CLS-484 will be administered at the determined recommended dose in combination with Programmed Cell Death-1 Inhibitor in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Arm Title
Combination Dose Escalation with VEGFR TKI
Arm Type
Experimental
Arm Description
ABBV-CLS-484 will be administered in combination with a Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) in subjects with solid tumors
Arm Title
Combination Expansion
Arm Type
Experimental
Arm Description
ABBV-CLS-484 will be administered at the determined recommended dose in combination with VEGFR TKI in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Intervention Type
Drug
Intervention Name(s)
ABBV-CLS-484
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Programmed Cell Death-1 (PD-1) Inhibitor
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-484 (Monotherapy)
Description
Maximum plasma/serum concentration of ABBV-CLS-484
Time Frame
Baseline Up to Approximately Day 42
Title
Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of Programmed Cell Death-1 (PD-1) Inhibitor (Combination therapy)
Description
Maximum plasma/serum concentration of PD-1 inhibitor
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFRTKI (Combination therapy) Maximum plasma/serum concentration of PD-1 inhibitor
Description
Maximum plasma/serum concentration of PD-1 inhibitor
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Time To Cmax (Tmax) Of ABBV-CLS-484 (Monotherapy)
Description
The amount of time taken to reach Cmax
Time Frame
Baseline Up to Approximately Day 42
Title
Dose Escalation: Time To Cmax (Tmax) Of PD-1 Inhibitor (Combination therapy)
Description
The amount of time taken to reach Cmax
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation Time to Cmax (Tmax) of VEGFR TKI (Combination therapy)
Description
The amount of time taken to reach Cmax
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of ABBV-CLS-484 (Monotherapy)
Description
Terminal phase elimination half-life (t1/2)
Time Frame
Baseline Up to Approximately Day 42
Title
Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of PD-1 Inhibitor (Combination therapy)
Description
Terminal phase elimination half-life (t1/2)
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Phase Elimination Rate Half-Life (t1/2) Of VEGFR TKI (Combination therapy)
Description
Terminal phase elimination half-life (t1/2)
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-484 (Monotherapy)
Description
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time Frame
Baseline Up to Approximately Day 42
Title
Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor (Combination therapy)
Description
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of VEGFR TKI (Combination therapy)
Description
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484
Description
The MTD and/or RP2D of ABBV-CLS-484 will be determined during the monotherapy therapy dose escalation phase of the study
Time Frame
Baseline Up to Approximately Day 42
Title
Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484 and a PD-1 Inhibitor (Combination therapy)
Description
The MTD and/or RP2D of ABBV-CLS-484 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose of ABBV-CLS-484 and a VEGFR TKI (Combination therapy)
Description
The MTD and/or RP2D of ABBV-CLS-484 and VEGFR TKI will be determined during the combination therapy dose escalation phase of the study
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Expansion: Objective Response Rate (ORR) Of ABBV-CLS-484 Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Monotherapy)
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline Up to Approximately Day 42
Title
Dose Expansion: Objective Response Rate (ORR) Of ABBV-CLS-484 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline Up to Approximately Day 64
Title
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And VEGFR TKI Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline Up to Approximately Day 64
Secondary Outcome Measure Information:
Title
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 Based On (RECIST) v1.1 (Monotherapy)
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And VEGFR TKI Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline through Study Completion (approximately 3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 disease (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 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: 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 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
847.283.8955
Email
abbvieclinicaltrials@abbvie.com
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Palmeri
Phone
203-361-4367
First Name & Middle Initial & Last Name & Degree
Patricia LoRusso
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-632-3090
First Name & Middle Initial & Last Name & Degree
Kartik Sehgal
Facility Name
Carolina BioOncology Institute
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Davis
Phone
704-947-6599
First Name & Middle Initial & Last Name & Degree
John Powderly
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Behr
Phone
412-623-6028
First Name & Middle Initial & Last Name & Degree
Jason Luke
Facility Name
Lifespan Cancer Institute at Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Nelson
Phone
401-444-6217
First Name & Middle Initial & Last Name & Degree
Benedito Carneiro
Facility Name
Next Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia DeLeon
Phone
210-580-9521
First Name & Middle Initial & Last Name & Degree
David Sommerhalder
Facility Name
IUCT Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33 5 31 15 51 29
First Name & Middle Initial & Last Name & Degree
Iphigenie KORAKIS
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
972 2 677 7111
First Name & Middle Initial & Last Name & Degree
Jonathan Cohen
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
972-3-5304498
First Name & Middle Initial & Last Name & Degree
Talia Golan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
State/Province
Kimiidera
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81-73-447-2300
First Name & Middle Initial & Last Name & Degree
Toshio Shimizu
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81-335422511
First Name & Middle Initial & Last Name & Degree
Noboru Yamamoto
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34-917567825
First Name & Middle Initial & Last Name & Degree
Emiliano Calvo Aller

12. IPD Sharing Statement

Learn more about this trial

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

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