Advanced Solid Tumors CancerPhase 1NCT04417465
First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors
A Phase 1 study testing ABBV-CLS-579, PD-1 inhibitor and VEGFR TKI in people with Advanced Solid Tumors Cancer, run by AbbVie at 17 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors Cancer
- What is being tested?
- ABBV-CLS-579, PD-1 inhibitor and VEGFR TKI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 3 Jun 2020to 21 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must weigh at least 35 kilograms (kg).
- For Monotherapy and Combination Dose Escalation:
- 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.
- 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.
- Indication with outcome of Prior PD-1/PD-L1 Targeted Therapy and other disease characteristics:
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- NSCLC
- 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
- ccRCC
- 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.
- HNSCC
- 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 months)
- 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
- An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy of ≥ 12 weeks.
- Laboratory values meeting protocol criteria.
- 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.
Who cannot join
- 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 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.
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- 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 interstitial lung disease or pneumonitis.
- Major surgery ≤ 28 days prior to first dose of study drug.
- Poorly controlled hypertension
- History of hemorrhage, including hemoptysis, hematemesis, or melena
- History of other malignancy, with the following exceptions:
- 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
- Adequately treated carcinoma in situ without evidence of disease
- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United States5 sites
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Yale University
New Haven, Connecticut, 06519
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Highlands Oncology Group Springdale
Springdale, Arkansas, 72762
Spain4 sites
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Japan3 sites
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
National Cancer Center Hospital East
Kashiwa-Shi, Chiba, 277-8577
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
France2 sites
Hopital Saint-Andre
Bordeaux, 33000
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-579 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
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.
Read more
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.
- Conditions
- Advanced Solid Tumors Cancer
- Being tested
- ABBV-CLS-579, PD-1 inhibitor, VEGFR TKI
- Keywords
- Cancer, Tumor, ABBV-CLS-579, PD-1, VEGFR TKI, ccRCC, NSCLC, MSI-H, HNSCC
- Medical subject headings
- Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-CLS-579Drug
Oral Capsule
PD-1 inhibitorDrug
Intravenous (IV) infusion
VEGFR TKIDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors Receives: Drug: ABBV-CLS-579 |
| Combination Dose Escalation with PD-1 | Experimental | ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors Receives: Drug: ABBV-CLS-579; Drug: PD-1 inhibitor |
| Backfill Cohorts with Monotherapy | Experimental | ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors Receives: Drug: ABBV-CLS-579 |
| Backfill Cohorts in Combination with PD-1 | Experimental | ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors Receives: Drug: ABBV-CLS-579; Drug: PD-1 inhibitor |
| Combination Expansion with PD-1 | Experimental | ABBV-CLS-579 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), microsatellite instability-high (MSI-H) tumors, and advanced clear cell renal cell carcinoma (ccRCC) Receives: Drug: ABBV-CLS-579; Drug: PD-1 inhibitor |
| Combination Expansion with VEGFR TKI | Experimental | ABBV-CLS-579 will be administered at the determined recommended dose in combination with Vascular Endothelial Growth (VEGFR) Factor Receptor Tyrosine Kinase Inhibitor (TKI) in subjects with advanced ccRCC. Receives: Drug: ABBV-CLS-579; Drug: VEGFR TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579
Maximum plasma/serum concentration of ABBV-CLS-579
Measured: Baseline Up to Approximately Day 44
Maximum Observed Plasma/Serum Concentration (Cmax) Of Metabolite M4
Maximum plasma/serum concentration of Metabolite M4
Measured: Baseline Up to Approximately Day 44
Maximum Observed Plasma/Serum Concentration (Cmax) Of PD-1 Inhibitor
Maximum plasma/serum concentration of PD-1 inhibitor
Measured: Baseline Up to Approximately Day 64
Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFR TKI
Maximum plasma/serum concentration of VEGFR TKI
Measured: Baseline Up to Approximately Day 64
Time To Cmax (Tmax) Of ABBV-CLS-579
The amount of time taken to reach Cmax
Measured: Baseline Up to Approximately Day 44
Time To Cmax (Tmax) Of Metabolite M4
The amount of time taken to reach Cmax
Measured: Baseline Up to Approximately Day 44
Time To Cmax (Tmax) Of PD-1 Inhibitor
The amount of time taken to reach Cmax
Measured: Baseline Up to Approximately Day 64
Time To Cmax (Tmax) Of VEGFR TKI
The amount of time taken to reach Cmax
Measured: Baseline Up to Approximately Day 64
Terminal Phase Elimination Rate Constant (β) Of ABBV-CLS-579
Terminal phase elimination rate constant (β or Beta)
Measured: Baseline Up to Approximately Day 44
Terminal Phase Elimination Rate Constant (β) Of Metabolite M4
Terminal phase elimination rate constant (β or Beta)
Measured: Baseline Up to Approximately Day 44
Terminal Phase Elimination Rate Constant (β) Of PD-1 Inhibitor
Terminal phase elimination rate constant (β or Beta)
Measured: Baseline Up to Approximately Day 64
Terminal Phase Elimination Rate Constant (β) Of VEGFR TKI
Terminal phase elimination rate constant (β or Beta)
Measured: Baseline Up to Approximately Day 64
Terminal Phase Elimination Half-Life (t1/2) Of ABBV-CLS-579
Terminal phase elimination half-life (t1/2)
Measured: Baseline Up to Approximately Day 44
Terminal Phase Elimination Half-Life (t1/2) Of Metabolite M4
Terminal phase elimination half-life (t1/2)
Measured: Baseline Up to Approximately Day 44
Terminal Phase Elimination Half-Life (t1/2) Of PD-1 Inhibitor
Terminal phase elimination half-life (t1/2)
Measured: Baseline Up to Approximately Day 64
Terminal Phase Elimination Half-Life (t1/2) Of VEGFR TKI
Terminal phase elimination half-life (t1/2)
Measured: Baseline Up to Approximately Day 64
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Measured: Baseline Up to Approximately Day 44
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of Metabolite M4
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Measured: Baseline Up to Approximately Day 44
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Measured: Baseline Up to Approximately Day 64
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of VEGFR TKI
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Measured: Baseline Up to Approximately Day 64
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579
The Expansion Dose and/or MTD of ABBV-CLS-579 will be determined during the monotherapy dose escalation phase of the study
Measured: Baseline through Study Completion (approximately 3 years)
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579 and a PD-1 Inhibitor
The Expansion Dose and/or MTD of ABBV-CLS-579 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Measured: Baseline through Study Completion (approximately 3 years)
Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Base On Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ABBV-CLS-579 in locally or metastatic HNSCC, NSCLC, MSI-H tumors, and advanced ccRCC
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Measured: Baseline through Study Completion (approximately 3 years)
Objective Response Rate (ORR) on RECIST v1.1, of ABBV-CLS-579 administered in combination with VEGFR TKI in advanced ccRCC
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Measured: Baseline through Study Completion (approximately 3 years)
Secondary outcomes (5)
Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Measured: Baseline through Study Completion (approximately 3 years)
Objective Response Rate (ORR) Of ABBV-CLS-579 Monotherapy Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Measured: Baseline through Study Completion (approximately 3 years)
Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1
BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Measured: Baseline through Study Completion (approximately 3 years)
Best Overall Response (BOR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On RECIST v1.1
BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Measured: Baseline through Study Completion (approximately 3 years)
Change from Baseline QTc
QT prolongation is measured by the QT interval measurement corrected for heart rate (QTc) change from baseline
Measured: Baseline through Study Completion (approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start3 Jun 2020
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Calico Life Sciences LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417465
- Sponsor's protocol ID
- M20-124
- Other IDs
- 2020-000639-28
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2020
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-579 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
- ClinicalTrials.gov ID
- NCT04417465
- Acronym / sponsor ID
- M20-124
- Conditions
- Advanced Solid Tumors Cancer
- Keywords
- Cancer, Tumor, ABBV-CLS-579, PD-1, VEGFR TKI, ccRCC, NSCLC, MSI-H
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Calico Life Sciences LLC
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: ABBV-CLS-579ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors |
| Combination Dose Escalation with PD-1 | Experimental | Drug: ABBV-CLS-579, Drug: PD-1 inhibitorABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors |
| Backfill Cohorts with Monotherapy | Experimental | Drug: ABBV-CLS-579ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors |
| Backfill Cohorts in Combination with PD-1 | Experimental | Drug: ABBV-CLS-579, Drug: PD-1 inhibitorABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors |
| Combination Expansion with PD-1 | Experimental | Drug: ABBV-CLS-579, Drug: PD-1 inhibitorABBV-CLS-579 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), microsatellite instability-high (MSI-H) tumors, and advanced clear cell renal cell carcinoma (ccRCC) |
| Combination Expansion with VEGFR TKI | Experimental | Drug: ABBV-CLS-579, Drug: VEGFR TKIABBV-CLS-579 will be administered at the determined recommended dose in combination with Vascular Endothelial Growth (VEGFR) Factor Receptor Tyrosine Kinase Inhibitor (TKI) in subjects with advanced ccRCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Must weigh at least 35 kilograms (kg).
- For Monotherapy and Combination Dose Escalation:
- For Combination Dose Expansion:
- Indication with outcome of Prior PD-1/PD-L1 Targeted Therapy and other disease characteristics:
- NSCLC
Key exclusion criteria (20 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-CLS-579Oral Capsule | Drug | Backfill Cohorts in Combination with PD-1, Backfill Cohorts with Monotherapy, Combination Dose Escalation with PD-1, Combination Expansion with PD-1, Combination Expansion with VEGFR TKI, Monotherapy Dose Escalation |
| PD-1 inhibitorIntravenous (IV) infusion | Drug | Backfill Cohorts in Combination with PD-1, Combination Dose Escalation with PD-1, Combination Expansion with PD-1 |
| VEGFR TKIOral Tablet | Drug | Combination Expansion with VEGFR TKI |
Primary outcome
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
Time frame: Baseline Up to Approximately Day 44
Maximum plasma/serum concentration of Metabolite M4
Maximum Observed Plasma/Serum Concentration (Cmax) Of PD-1 Inhibitor
Time frame: Baseline Up to Approximately Day 64
Maximum plasma/serum concentration of PD-1 inhibitor
Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFR TKI
Time frame: Baseline Up to Approximately Day 64
Maximum plasma/serum concentration of VEGFR TKI
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
Time To Cmax (Tmax) Of VEGFR TKI
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 Constant (β) Of VEGFR TKI
Time frame: Baseline Up to Approximately Day 64
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination 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 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 Half-Life (t1/2) Of PD-1 Inhibitor
Time frame: Baseline Up to Approximately Day 64
Terminal phase elimination half-life (t1/2)
Terminal Phase Elimination Half-Life (t1/2) Of VEGFR TKI
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
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of VEGFR TKI
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 Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579
Time frame: Baseline through Study Completion (approximately 3 years)
The Expansion Dose and/or MTD of ABBV-CLS-579 will be determined during the monotherapy dose escalation phase of the study
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579 and a PD-1 Inhibitor
Time frame: Baseline through Study Completion (approximately 3 years)
The Expansion Dose and/or MTD of ABBV-CLS-579 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Base On Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ABBV-CLS-579 in locally or metastatic HNSCC, NSCLC, MSI-H tumors, and advanced ccRCC
Time frame: Baseline through Study Completion (approximately 3 years)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Objective Response Rate (ORR) on RECIST v1.1, of ABBV-CLS-579 administered in combination with VEGFR TKI in advanced ccRCC
Time frame: Baseline through Study Completion (approximately 3 years)
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
5 secondary outcomes
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)
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)
Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1
Time frame: Baseline through Study Completion (approximately 3 years)
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)
Change from Baseline QTc
Time frame: Baseline through Study Completion (approximately 3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-CLS-579, PD-1 inhibitor and VEGFR TKI in people with Advanced Solid Tumors Cancer, run by AbbVie at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Spain, Japan, France, Israel and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579 (time frame: Baseline Up to Approximately Day 44). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.