Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ABBV-CLS-484 alone or with another cancer drug in people with tumors that have grown nearby or spread to other parts of the body. It aims to find a safe dose, learn how the drug works in the body, and see whether it helps treat cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Weigh at least 35 kg (about 77 pounds). Be able to care for yourself and be up and about for more than half of your waking hours.
- Be expected to live at least 12 weeks and have blood test results that meet study rules.
- Have cancer that can be measured. Have a heart tracing test that meets the study’s heart rhythm rules.
- For groups testing higher doses: have advanced cancer confirmed by a tissue or cell test. You must have had at least one cancer drug treatment, and standard treatment must have failed or no effective standard treatment must exist.
- For the later group taking ABBV-CLS-484 alone: have certain head and neck, non-small cell lung, or clear cell kidney cancers. You must have had prior treatment for advanced cancer, including PD-1/PD-L1 treatment, which helps the immune system fight cancer, and meet rules about how it worked.
- For later groups combining it with a PD-1 drug: have certain head and neck, lung, or clear cell kidney cancers that came back. Prior PD-1/PD-L1 treatment must have made the cancer disappear or shrink, or kept it stable for more than 6 months.
- The later PD-1 combination group also accepts advanced MSI-H tumors, which have certain DNA changes, that grew despite prior PD-1/PD-L1 treatment.
- For the later VEGFR TKI combination group: have advanced clear cell kidney cancer that came back and no more than one prior VEGFR TKI, a drug that blocks blood vessel growth. You must not have recent bleeding or poorly controlled high blood pressure.
Who can't join
- Untreated cancer in the brain or its lining. Treated cancer there may be allowed if it has been stable for at least 28 days and does not need ongoing steroid treatment.
- Ongoing moderate or worse side effects from past cancer treatment, except hair loss, or moderate or worse nerve damage.
- A history of hepatitis B, hepatitis C, or HIV infection; or a known active infection with the virus that causes COVID-19.
- Certain serious heart problems or moderate to severe liver disease within the past 6 months; uncontrolled serious hormone disorders; or other health or mental health problems that could make joining unsafe.
- Trouble absorbing medicines through the gut or inability to swallow capsules. Major surgery within 28 days before the first study dose.
- Past lung inflammation or lung scarring disease. Past immune-based cancer treatment that caused lung inflammation, severe immune side effects, an allergic reaction, or side effects that required stopping treatment.
- An active disease in which the immune system attacks the body that needed whole-body treatment within the past 2 years, with some exceptions. A past organ transplant or stem cell transplant from a donor.
- A history of another cancer, unless it meets the study’s exceptions, such as certain fully treated early cancers or cancer inactive for at least 3 years with a low risk of returning.
Simplified for readability. The official criteria below are what the study team uses.
Official 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: * Participants with histologically or cytologically proven metastatic or locally advanced tumors, 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 Monotherapy Dose Expansion only: * Participants 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 * Participants no recent history of hemorrhage, including hemoptysis, hematemesis, or melena * Participants 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.
Study sites (15)
AZ
- University of Arizona Cancer Center - Tucson /ID# 262698 · Tucson, AZ 85724More trials in Tucson
CT
- Yale University School of Medicine /ID# 225707 · New Haven, CT 06510More trials in New Haven
MA
- Beth Israel Deaconess Medical Center /ID# 252009 · Boston, MA 02215-5400More trials in Boston
- Dana-Farber Cancer Institute /ID# 249642 · Boston, MA 02215More trials in Boston
MD
- Johns Hopkins Hospital /ID# 254056 · Baltimore, MD 21287Site Coordinator · Study contact · 443-287-8312More trials in Baltimore
MI
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010 · Ann Arbor, MI 48109More trials in Ann Arbor
NC
- Duke Cancer Center /ID# 251975 · Durham, NC 27710Site Coordinator · Study contact · (919) 681-7460More trials in Durham
- Carolina BioOncology Institute /ID# 225704 · Huntersville, NC 28078More trials in Huntersville
NY
- NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869 · New York, NY 10016Site Coordinator · Study contact · (212)-731-6230More trials in New York
PA
- Perelman Center for Advanced Medicine /ID# 250188 · Philadelphia, PA 19104Site Coordinator · Study contact · (215) 316-5151More trials in Philadelphia
- UPMC Hillman Cancer Ctr /ID# 225706 · Pittsburgh, PA 15232More trials in Pittsburgh
RI
- Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705 · Providence, RI 02903-4923More trials in Providence
TX
- University of Texas Southwestern Medical Center /ID# 251974 · Dallas, TX 75390-7208More trials in Dallas
- University of Texas MD Anderson Cancer Center /ID# 252004 · Houston, TX 77030Site Coordinator · Study contact · 713-792-2121More trials in Houston
- NEXT Oncology /ID# 225708 · San Antonio, TX 78229More trials in San Antonio