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Advanced Solid Tumors CancerPhase 1NCT02955251

A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

A Phase 1 study testing ABBV-428 and Nivolumab in people with Advanced Solid Tumors Cancer, run by AbbVie at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
ABBV-428 and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
15 sitesin 4 countries
Study dates
18 Nov 2016to 29 Oct 2019
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
  • Participants have adequate bone marrow, renal, hepatic and coagulation function.
  • For all dose expansion arms, participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
  • Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.

Who cannot join

  • Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
  • History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
  • Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
  • Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
  • Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

United States7 sites

  • University of Chicago /ID# 154440

    Chicago, Illinois, 60637-1443

  • Greenville Hospital System /ID# 154437

    Greenville, South Carolina, 29605

  • MD Anderson Cancer Center at Texas Medical Center /ID# 154441

    Houston, Texas, 77030-4000

  • Fox Chase Cancer Center /ID# 170665

    Philadelphia, Pennsylvania, 19111

  • UC Davis Comprehensive Cancer Center - Main /ID# 154439

    Sacramento, California, 95817

  • South Texas Accelerated Research Therapeutics /ID# 154442

    San Antonio, Texas, 78229

  • HonorHealth Research Institute - Pima /ID# 155461

    Scottsdale, Arizona, 85258-2345

Other trials in United States

France5 sites

  • Institut Bergonie /ID# 202391

    Bordeaux, Gironde, 33000

  • Centre Leon Berard /ID# 168072

    Lyon, Rhone, 69373

  • Hopital de la Timone /ID# 162256

    Marseille, Provence-Alpes-Côte d'Azur Region, 13385

  • Institut Curie /ID# 162258

    Paris, Île-de-France Region, 75248

  • Gustave Roussy /ID# 162257

    Villejuif, Île-de-France Region, 94805

Other trials in France

Australia2 sites

  • Chris O'Brien Lifehouse /ID# 163131

    Camperdown, New South Wales, 2050

  • Northern Cancer Institute /ID# 163132

    St Leonards, New South Wales, 2065

Other trials in Australia

Taiwan1 site

  • National Taiwan Univ Hosp /ID# 169034

    Taipei City, Taipei, 10002

Other trials in Taiwan

About this study

Official title: A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

Being tested
ABBV-428, Nivolumab
Keywords
Cancer, Neoplasm, Advanced solid tumor, Nivolumab, Non-small cell lung cancer (NSCLC), Non-squamous NSCLC, Ovarian cancer
Medical subject headings
Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-428Drug

    ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.

  • NivolumabDrug

    Also called OPDIVO

    Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.

Study groups in NCT02955251
Study groupRoleWhat they receive
Arm 1ExperimentalABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).
Receives: Drug: ABBV-428
Arm A, B, and CExperimentalAdditional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.
Receives: Drug: ABBV-428
Arm DExperimentalAdditional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.
Receives: Drug: ABBV-428; Drug: Nivolumab
Arm 2ExperimentalABBV-428 plus nivolumab.
Receives: Drug: ABBV-428; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    Measured: First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose

  2. Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab

    If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.

    Measured: 1 day of study drug administration within the 28-day cycle at the designated cohort dose

  3. Area under the serum concentration-time curve (AUC) of ABBV-428

    Measured: Up to 30 days after a 24-month treatment period

  4. Terminal half-life (t1/2) of ABBV-428

    Measured: Up to 30 days after a 24-month treatment period

  5. Maximum observed serum concentration (Cmax) of ABBV-428

    Measured: Up to 30 days after a 24-month treatment period

  6. Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab

    The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.

    Measured: Up to 2 years

  7. Time to Cmax (Tmax) of ABBV-428

    Measured: Up to 30 days after a 24-month treatment period

Secondary outcomes (4)

  1. Duration of Objective Response (DOR)

    DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.

    Measured: Up to 30 days after a 24-month of treatment period

  2. Clinical benefit rate (CBR)

    CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.

    Measured: Up to 30 days after a 24-month of treatment period

  3. Progression-Free Survival (PFS)

    PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first

    Measured: Up to 30 days after a 24-month of treatment period

  4. Objective Response Rate (ORR)

    ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.

    Measured: Up to 30 days after a 24-month of treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2016 (estimated)
  2. Study start18 Nov 2016
  3. Primary completion29 Oct 2019
  4. Study completion29 Oct 2019

Resources

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
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955251
Sponsor's protocol ID
M15-819
Other IDs
2016-001461-88, 2016
Status last verified
Jul 2020
First submitted
2 Nov 2016
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2):e002015. doi: 10.1136/jitc-2020-002015.

    PubMed 33608377

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-428 and Nivolumab in people with Advanced Solid Tumors Cancer, run by AbbVie at 15 sites in 4 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 4 inclusion and 6 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 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, France, Australia, Taiwan. 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?

Number of participants with adverse events (time frame: First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02955251, which also lists 1 linked publication.

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 20 Jul 2020.

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