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NeoplasmsPhase 1NCT02134197

Dose-escalation Study of Lupartumab Amadotin (BAY1129980)

A Phase 1 study testing Lupartumab Amadotin (BAY1129980) in people with Neoplasms, run by Bayer at 15 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate: The side effects of BAY1129980 when given every 21 days different dose levels. Determine the dose level of BAY1129980 that should be tested in future clinical research studies. Measure how much BAY1129980 is in the blood at specific times after administration. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Lupartumab Amadotin (BAY1129980)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
15 sitesUnited States
Study dates
22 May 2014to 30 Aug 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects must be ≥ 18 years at the first screening examination / visit
  • All subjects must provide a tumor tissue sample from [Formalin Fixed Paraffin Embedded (FFPE) slides] archival tissue or fresh biopsy collected before Cycle 1, Day 1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
  • Life expectancy of at least 12 weeks
  • Radiographically or clinically evaluable tumor. In the expansion phase, disease must be measurable according to RECIST 1.1.
  • Adequate bone marrow, liver, and renal function
Show all 9Show fewer
  • Histologically or cytologically confirmed solid tumors known to express C4.4a (eg, carcinomas of the lung, head \& neck SCC, esophagus SCC (squamous cell carcinoma),colon, ovary, prostate, and breast) that are refractory to any standard therapy, or have no standard therapy available, or for which subjects actively refuse any treatment that would be regarded as standard and in whom, in the opinion of the investigator, experimental therapy with BAY1129980 may be beneficial.
  • A signed informed consent must be obtained prior to any study-specific procedures.
  • Measurable disease with at least one lesion that can be accurately measured in at least one dimension according to RECIST 1.1

Who cannot join

  • Anticancer chemotherapy, experimental cancer therapy, or cancer immunotherapy within 4 weeks prior to first dose study drug. Anticancer therapy is defined as any agent or combination of agents with clinically proven anti tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints.
  • Skin toxicity including but not limited to erythema, rash, ulceration, and open wound that is still clinically present and considered as acute or chronic.
  • Subjects with psoriasis or other severe skin disease (eg, autoimmune skin disease, active erythematous skin lesions, etc.)
  • Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
  • Prior local radiotherapy is allowed if it is completed at least 4 weeks prior to the first dose of study drug and the subject has evaluable lesions not previously irradiated
  • Significant liver dysfunction determined as Child-Pugh score B or C
Show all 18Show fewer
  • History of symptomatic metastatic brain or meningeal tumors unless the subject is >3 months from the end of definitive therapy before the first dose of study drug and has clinically or radiologically no evidence of tumor growth.
  • History of clinically significant cardiac disease.
  • Anti-platelet drugs within 4 weeks prior to the first dose of study drug. Anti-platelet drugs are defined as any agent or combination of agents with clinically proven anti-thrombotic activity administered by any route with the purpose of affecting blood clotting ability of the subject.
  • Participation in another clinical trial in which they received active therapy within 4 weeks prior to the first dose of study drug.
  • Subjects with CNS symptoms should undergo a CT scan or MRI of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable. However, subjects with spinal cord compression should be excluded.
  • Subjects with severe renal impairment (GFR <50 mL/min/1.73 m²) or on dialysis.
  • History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of study drug.
  • Current evidence or previous medical history of (ie, any absolute risk of latent infection) hepatitis B or C, any active hepatitis, or human immunodeficiency virus (HIV) infection. Active clinically serious infections > CTCAE Grade 2.
  • Major surgery or significant trauma within 2 weeks prior to the first dose of study drug.
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study result.
  • Subjects who are pregnant or are breast-feeding.
  • Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance to the study.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Buffalo, New York, 14263

  • Study site

    Dallas, Texas, 75230

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Gainesville, Georgia, 32610

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Houston, Texas, 77030

  • Study site

    La Jolla, California, 92093

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Seattle, Washington, 98109-1023

  • Study site

    Stanford, California, 94305

  • Study site

    Washington D.C., District of Columbia, 20007-2197

  • Study site

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: An Open-label Phase I Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetics, and Pharmacodynamics of the Anti-C4.4a Antibody Drug Conjugate BAY1129980 in Subjects With Advanced Solid Tumors Known to Express C4.4a

The purpose of this study is to evaluate:

  • The side effects of BAY1129980 when given every 21 days different dose levels.
  • Determine the dose level of BAY1129980 that should be tested in future clinical research studies.
  • Measure how much BAY1129980 is in the blood at specific times after administration.
  • If treatment with BAY1129980 shows any effect on reducing the tumor growth.
  • If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not.
  • If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).
Read the detailed description

The relatively restricted C4.4a expression pattern provides a target for the selective delivery of a cytotoxic drug to C4.4.a-expressing tumor cells by means of a suitable antibody-drug conjugate. The subject population eligible for the current study will be those subjects with advanced malignancies known to express C4.4a, which are refractory to standard therapy or those without standard therapy or actively refusing any treatment, which would be regarded as standard and in whom, in the opinion of the investigator, experimental therapy with BAY1129980 may be beneficial.Depending on the number of dose-escalating steps and the occurrence of DLTs, the planned numbers of subjects could vary.It is expected that up to 90 subjects may participate in the dose-expansion phase of the study and up to 6-9 subjects may particpate in the dose re-esclation phase.The study assessments in the expansion phase of the study are identical to those in the dose-escalation phase.

Amendment # 3 includes changes to DLT criteria (hematological and non-hematological) and allows for frequent follow-up for subjects experiencing drug-related liver toxicity that warrants dose reduction or dose interruptions.

Conditions
Neoplasms
Being tested
Lupartumab Amadotin (BAY1129980)
Keywords
Oncology, Solid tumors, Antibody drug conjugate, Maximum tolerated dose
Medical subject headings
Neoplasms

What participants receive

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

  • Lupartumab Amadotin (BAY1129980)Drug

    Starting dose is 0.15mg/kg intravenous (I.V.) administration every 21 days.

Study groups in NCT02134197
Study groupRoleWhat they receive
Lupartumab Amadotin (BAY1129980)ExperimentalDose escalation with consecutive expansion at MTD (maximum tolerated dose) with BAY1129980.
Receives: Drug: Lupartumab Amadotin (BAY1129980)

What is being measured

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

  1. Maximum tolerated dose (MTD)

    MTD is defined as the maximum dose at which the incidence of DLTs (dose limiting toxicities) during Cycle 1 is below 20%, or the maximum dose administered, whichever is achieved first during dose escalation.

    Measured: 21 days

  2. Number of participants with adverse events as a measure of safety and tolerability

    Measured: Up to 2 years

Secondary outcomes (4)

  1. C4.4a expression levels in tumour tissue as measured by immunohistochemistry (IHC)

    Measured: Baseline

  2. Tumor response evaluation following RECIST 1.1 criteria

    Measured: Up to 2 years

  3. Plasma concentration of BAY1129980 characterized by AUC (0-tlast)

    Measured: 2 years

  4. Antidrug and antibody titer

    Measured: Baseline and up to 2 years

Timeline

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

  1. First posted9 May 2014 (estimated)
  2. Study start22 May 2014
  3. Primary completion30 Aug 2018
  4. Study completion30 Aug 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02134197
Sponsor's protocol ID
16044
Status last verified
Dec 2019
First submitted
6 May 2014
Last updated
11 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Willuda J, Linden L, Lerchen HG, Kopitz C, Stelte-Ludwig B, Pena C, Lange C, Golfier S, Kneip C, Carrigan PE, Mclean K, Schuhmacher J, von Ahsen O, Muller J, Dittmer F, Beier R, El Sheikh S, Tebbe J, Leder G, Apeler H, Jautelat R, Ziegelbauer K, Kreft B. Preclinical Antitumor Efficacy of BAY 1129980-a Novel Auristatin-Based Anti-C4.4A (LYPD3) Antibody-Drug Conjugate for the Treatment of Non-Small Cell Lung Cancer. Mol Cancer Ther. 2017 May;16(5):893-904. doi: 10.1158/1535-7163.MCT-16-0474. Epub 2017 Mar 14.

    PubMed 28292941

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lupartumab Amadotin (BAY1129980) in people with Neoplasms, run by Bayer at 15 sites in United States.

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 9 inclusion and 18 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: stopped early, as of the sponsor's last update on 11 Dec 2019. 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. 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 was stopped early. Results are not available in the source record.

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?

Maximum tolerated dose (MTD) (time frame: 21 days). The study lists 2 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 NCT02134197, 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 11 Dec 2019.

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