Durham, NCNCT04777994Now EnrollingIRB Ready

Advanced Solid Tumor Cancer Clinical Trial in Durham, NC

Access cutting-edge advanced solid tumor cancer treatment through this clinical trial at a research site in Durham. Study-provided care at no cost to qualified participants.

Sponsored by Calico Life Sciences LLC

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Expert Care in Durham

Access advanced solid tumor cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related advanced solid tumor cancer treatment provided free

Apply for This Durham Location

Check if you qualify for this advanced solid tumor cancer clinical trial in Durham, NC

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Durham

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Durham site if eligible
  4. 4Begin participation

About This Advanced Solid Tumor Cancer Study in Durham

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.

Sponsor: Calico Life Sciences LLC

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT04777994) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Solid Tumor Cancer Treatment Options in Durham, NC

If you're searching for advanced solid tumor cancer treatment options in Durham, NC, this clinical trial (NCT04777994) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced solid tumor cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced solid tumor cancer clinical trials near you to find additional studies recruiting in your area.

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