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New cancer drug combo trial launches for Hard-to-Treat tumors

NCT ID NCT04777994

Disease control Sponsor: Calico Life Sciences LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing an experimental oral drug called ABBV-CLS-484, either alone or combined with other cancer treatments, in people with advanced solid tumors that have spread or cannot be removed by surgery. The study aims to find safe and tolerable doses and to see if the drug can shrink tumors. About 248 participants will take part across multiple cancer types, including head and neck, lung, and kidney cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABBV-CLS-484 (oral drug)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early Phase 1 trial, so the main goals are safety and dosing, not yet proving effectiveness. Many experimental cancer drugs do not succeed in later trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 248 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma nonpapillary renal cell carcinoma Recurrence renal cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beth Israel Deaconess Medical Center /ID# 252009

    RECRUITING

    Boston, Massachusetts, 02215-5400, United States

  • Carolina BioOncology Institute /ID# 225704

    COMPLETED

    Huntersville, North Carolina, 28078, United States

  • Centre Antoine-Lacassagne /ID# 252606

    RECRUITING

    Nice, Provence-Alpes-Côte d'Azur Region, 06189, France

  • Dana-Farber Cancer Institute /ID# 249642

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Center /ID# 251975

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hadassah Medical Center /ID# 252366

    RECRUITING

    Jerusalem, Jerusalem, 91120, Israel

  • Hopital Foch /ID# 252607

    RECRUITING

    Suresnes, 92151, France

  • Hospital Universitario 12 de Octubre /ID# 257374

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario HM Sanchinarro /ID# 228034

    RECRUITING

    Madrid, Madrid, 28050, Spain

  • IUCT Oncopole /ID# 252673

    RECRUITING

    Toulouse, Occitanie, 31059, France

  • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 252524

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Institut Paoli-Calmettes /ID# 260956

    RECRUITING

    Marseille, Bouches-du-Rhone, 13009, France

  • Johns Hopkins Hospital /ID# 254056

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705

    RECRUITING

    Providence, Rhode Island, 02903-4923, United States

  • NEXT Oncology /ID# 225708

    COMPLETED

    San Antonio, Texas, 78229, United States

  • NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869

    RECRUITING

    New York, New York, 10016, United States

  • National Cancer Center Hospital /ID# 225884

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • Perelman Center for Advanced Medicine /ID# 250188

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Rabin Medical Center /ID# 263631

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Samsung Medical Center /ID# 260664

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital /ID# 254635

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • The Chaim Sheba Medical Center /ID# 226756

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

  • UPMC Hillman Cancer Ctr /ID# 225706

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Arizona Cancer Center - Tucson /ID# 262698

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Texas MD Anderson Cancer Center /ID# 252004

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center /ID# 251974

    RECRUITING

    Dallas, Texas, 75390-7208, United States

  • Wakayama Medical University Hospital /ID# 252988

    RECRUITING

    Wakayama, Wakayama, 641-8510, Japan

  • Yale University School of Medicine /ID# 225707

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Yonsei University Health System Severance Hospital /ID# 260665

    RECRUITING

    Seoul, 03722, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.