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NeoplasmsPhase 2NCT04596150

Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

A Phase 2 study testing CX-2009 and CX-072 in people with Neoplasms and Breast Neoplasms, run by CytomX Therapeutics at 42 sites in 3 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

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CX-2009 and CX-072
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
42 sitesin 3 countries
Study dates
29 Dec 2020to 2 Jun 2023
Phase
Phase 2
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

  • Arm A: inoperable, locally advanced or metastatic HR-positive/HER2-negative breast cancer. Patients must have received 0 to 2 prior cytotoxic chemotherapy in the inoperable, locally advanced, or metastatic setting
  • Arm B and Arm C: inoperable, locally advanced or metastatic TNBC; archival or fresh tumor tissue must have high CD166 expression by immunohistochemistry (IHC). Patients must have received 1 - 3 prior lines of therapy for inoperable, locally advanced, or metastatic TNBC
  • Arm C only: Patients must be Programmed Death Ligand 1 (PD-L1) positive by an FDA-approved test. For patients who have received prior checkpoint inhibitors (CPI) therapy: if the CPI was the most recent treatment given prior to enrollment into this study, the patient must not have progressed within 120 days of the first dose of the CPI
  • Measurable disease per RECIST v1.1
  • Adults, at least 18 years of age
  • Eastern Cooperative Oncology Group performance status of 0 or 1
Show all 10Show fewer
  • Adequate baseline Laboratory Values
  • Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control at least 1 month prior to first dose, during study treatment, and for a period of 50 days after the last dose of CX-2009 and 105 days after the last dose of CX-072 (Arm C).
  • Patients with brain metastases that are ≤ 1 cm, are asymptomatic, and require no treatment may be eligible after discussion with Medical Monitor.
  • Additional inclusion criteria may apply

Who cannot join

  • History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator present a low risk for recurrence
  • Untreated symptomatic brain and/or leptomeningeal metastases
  • Unresolved prior therapy-related acute toxicity Grade > 1, including neuropathy. Alopecia and other nonacute toxicities are not exclusionary
  • Active or chronic corneal disorder
  • Serious concurrent illness
  • History of allogeneic tissue/solid organ transplant, stem cell transplant, or bone marrow transplant
Show all 15Show fewer
  • Arm C only:
  • History of or current active autoimmune diseases
  • History of myocarditis regardless of the cause
  • History of intolerance to prior immune CPI therapy defined as the need to discontinue treatment due to an immune-related Adverse Event (AE)
  • Immunosuppressive therapy including chronic systemic steroid (≥ 10 mg daily prednisone equivalents) within 14 days of Cycle 1 Day 1 (C1D1). However, patients who require brief courses of steroids (eg, as prophylaxis for IV contrast or for treatment of an allergic reaction) may be eligible with Medical Monitor approval. Inhaled or topical steroids are permitted.
  • History of severe allergic or anaphylactic reactions to previous monoclonal antibody (mAb) therapy or known hypersensitivity to any component of Probody therapeutic
  • Prior treatment with maytansinoid-containing drug conjugates (eg, DM1 or DM4 antibody drug conjugate, including trastuzumab emtansine)
  • Pregnant or breastfeeding
  • Additional exclusion criteria may apply

Trial locations and contacts

42 sites in 3 countries.

42 sites in 3 countries

United States27 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 78809

  • MGH

    Boston, Massachusetts, 02114

  • DRCI

    Boston, Massachusetts, 02215

  • MUSC

    Charleston, South Carolina, 29425

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • FCS - South

    Fort Myers, Florida, 33901

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Baptist Medical Center

    Jacksonville, Florida, 32207

  • Moores Cancer Center

    La Jolla, California, 92093

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Los Angeles Hematology Oncology Medical

    Los Angeles, California, 90017

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Allina Health System

    Minneapolis, Minnesota, 55407

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • UPMC Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Hematology Oncology Assoc of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Huntsman Cancer Institute Research

    Salt Lake City, Utah, 84112

  • UCLA David Geffen

    Santa Monica, California, 90404

  • Summit Cancer Centers

    Spokane, Washington, 99208

  • FCS - North

    St. Petersburg, Florida, 33705

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • UT Health East Texas HOPE Cancer Center

    Tyler, Texas, 75701

Other trials in United States

Spain8 sites

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Vall d'Hebron University Hospital

    Barcelona, 08036

  • Institut Catala Oncologia

    Barcelona, 08908

  • Hospital Universitario Ramn y Cajal

    Madrid, 28034

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • NEXT Oncology

    Madrid, 28050

  • Hospital Parc Tauli

    Sabadell, 08208

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

South Korea7 sites

  • Soon Chun Hyang University Cheonan Hospital SCHMC

    Cheonan

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination With Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC

Read the detailed description

Eligible patients will be enrolled to the treatment arm based on breast cancer subtype.

Patients will receive study treatment on Day 1 of a Q3W cycle. Treatment with CX-2009 monotherapy (Arms A and B) or CX-2009 in combination with CX-072 (Arm C) will be given until disease progression or symptomatic deterioration, unacceptable toxicity necessitating treatment discontinuation, or if the patient meets certain study defined criteria for discontinuation. On-treatment tumor assessments, will occur every 6 weeks per RECIST v1.1 for the first 48 weeks, and every 12 weeks thereafter.

Being tested
CX-2009, CX-072
Keywords
HR-positive/HER2-non-amplified, HR+, HER2 non-amplified, Hormone Receptor, N2'-deacetyl-N2'-(4-mercapto-4-methyl-1-oxopentyl)-maytansine (DM4), Cluster of Differentiation 166 (CD166), Triple negative breast cancer, Breast cancer, Probody, Armed antibody, Mytansine, Hormone Receptor Positive, DM4, CD166, PD-L1, Praluzatamab Ravtansine, Pacmilimab
Medical subject headings
Neoplasms, Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • CX-2009Drug

    Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W)

  • CX-072Drug

    Intravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W)

Study groups in NCT04596150
Study groupRoleWhat they receive
ARM A - CX-2009 Monotherapy, HR-positive/HER2-negativeExperimentalCX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer
Receives: Drug: CX-2009
ARM B - CX-2009 Monotherapy, TNBCExperimentalCX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC)
Receives: Drug: CX-2009
ARM C - CX-2009 Combination therapy, TNBCExperimentalCX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
Receives: Drug: CX-2009; Drug: CX-072

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is the proportion of patients in the efficacy-evaluable population with a best response of Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Central Radiology Review (CRR)

    Measured: 30 months

Secondary outcomes (5)

  1. Investigator-assessed Progression-Free Survival (PFS)

    The time from the date of the first dose of study treatment until documentation of objective tumor progression based on RECIST v1.1 or until death due to any cause

    Measured: 30 Months

  2. Duration of Response (DoR)

    The time that measurement criteria are met for CR or PR (based on RECIST v1.1) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started)

    Measured: 30 Months

  3. Overall Survival (OS)

    The time from treatment initiation until death as a result of any cause

    Measured: 30 Months

  4. Clinical Benefit Rate (CBR) at 16 Weeks

    This will include sum of confirmed Complete plus Partial Responses plus stable disease at 16 weeks on treatment

    Measured: 30 Months

  5. Clinical Benefit Rate (CBR) at 24 Weeks

    This will include sum of confirmed Complete plus Partial Responses plus stable disease at 24 weeks on treatment

    Measured: 30 Months

Timeline

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

  1. First posted22 Oct 2020
  2. Study start29 Dec 2020
  3. Primary completion2 Jun 2023
  4. Study completion2 Jun 2023

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04596150
Sponsor's protocol ID
CTMX-2009-002
Other IDs
2020-004618-36
Status last verified
Jan 2024
First submitted
2 Oct 2020
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CX-2009 and CX-072 in people with Neoplasms and Breast Neoplasms, run by CytomX Therapeutics at 42 sites in 3 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 10 inclusion and 15 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Spain, South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective Response Rate (ORR) (time frame: 30 months). 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 NCT04596150.

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 23 Jan 2024.

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