NCT04777994RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 248 (estimated)
- First submitted
- 25 Feb 2021
- Start date
- 9 Mar 2021
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Calico Life Sciences LLC
- Diseases
- Head and neck cancer, Kidney cancer, Lung cancer
- NCT number
- NCT04777994
- EU CT number
- 2023-507568-38-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 248
- From 9 Mar 2021 to the primary completion date, 31 Oct 2026
- 30 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
- 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.
- Major surgery \<= 28 days prior to first dose of study drug
Other illness
- 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)
- 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.
- 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.
- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.
Age
- 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.
Other
- Unresolved Grade 2 or higher peripheral neuropathy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524 Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario 12 de Octubre /ID# 257374 Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro /ID# 228034 Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Institut Paoli-Calmettes /ID# 260956 Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Antoine-Lacassagne /ID# 252606 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Hopital Foch /ID# 252607 Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| IUCT Oncopole /ID# 252673 Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Hadassah Medical Center /ID# 252366 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Rabin Medical Center /ID# 263631 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 226756 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| National Cancer Center Hospital /ID# 225884 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Recruiting |
| Wakayama Medical University Hospital /ID# 252988 Coordinator of this site? Confirm its status | Wakayama | Japan | Recruiting |
| Samsung Medical Center /ID# 260664 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Yonsei University Health System Severance Hospital /ID# 260665 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital /ID# 254635 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010 Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Johns Hopkins Hospital /ID# 254056 Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Beth Israel Deaconess Medical Center /ID# 252009 Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Dana-Farber Cancer Institute /ID# 249642 Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Texas Southwestern Medical Center /ID# 251974 Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Duke Cancer Center /ID# 251975 Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| University of Texas MD Anderson Cancer Center /ID# 252004 Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Carolina BioOncology Institute /ID# 225704 Coordinator of this site? Confirm its status | Huntersville | United States | Completed |
| Yale University School of Medicine /ID# 225707 Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Perelman Center for Advanced Medicine /ID# 250188 Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| UPMC Hillman Cancer Ctr /ID# 225706 Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705 Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| NEXT Oncology /ID# 225708 Coordinator of this site? Confirm its status | San Antonio | United States | Completed |
| University of Arizona Cancer Center - Tucson /ID# 262698 Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.