Solid Tumor, AdultPhase 1/2NCT03543813
PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
A Phase 1/2 study testing CX-2029 in people with Solid Tumor, Adult and Head and Neck Cancer, run by CytomX Therapeutics at 25 sites in 4 countries.
Trial summary
The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Head and Neck Cancer, Non Small Cell Lung Cancer
- What is being tested?
- CX-2029
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 15 Jun 2018to 1 Jun 2023
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
- Patients demonstrating disease progression after treatment with approved therapies that are known to confer life-prolonging benefit, or who are intolerant to or have declined treatment
- Agreement to provide mandatory archival tissue or fresh biopsy
- At least 18 years of age
- For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
- For Arms B and C, histologically or cytologically confirmed metastatic or locally advanced unresectable HNSCC, DLBCL, NSCLC (squamous cell histology only), or esophageal (EAC, ESCC, or GE junction) cancer
- Additional inclusion criteria may apply
Who cannot join
- Neuropathy > Grade 1
- Serious concurrent illness, including clinically relevant active infection
- Clinically significant iron metabolism disorders (eg, sickle cell anemia)
- Significant cardiac disease such as recent myocardial infarction
- History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
- Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
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- History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
- Currently receiving anticoagulation therapy with warfarin;
- Major surgery (requiring general anesthesia) within 3 months prior to dosing.
- Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
- Transfusion dependent anemia with transfusion dependency of ≥3 months
- Use of iron chelators
- Additional exclusion criteria may apply
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States15 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
California Cancer Associates for Research and Excellence
Encinitas, California, 92024
Virginia Cancer Specialists
Fairfax, Virginia, 22031
START Midwest
Grand Rapids, Michigan, 49546
Forrest General Cancer Center
Hattiesburg, Mississippi, 39401
MD Anderson Cancer Center
Houston, Texas, 77030
Florida Cancer Specialists
Lake Mary, Florida, 32746
University of Southern California
Los Angeles, California, 90033
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
New York University (NYU) Clinical Cancer Center
New York, New York, 10016
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Providence Portland Medical Center
Portland, Oregon, 97213
Washington University - St. Louis
St Louis, Missouri, 63110
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario La Paz, Servicio de Oncología
Madrid, 28046
Centro Integral Oncologico Clara Campal, START Madrid
Madrid, 28050
Hospital Universitario Quiron de Madrid
Madrid, 28223
South Korea3 sites
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Kangbuk Samsung Hospital
Seoul, Jongno-gu, 03181
Severance Hospital- Yonsei Cancer Center
Seoul, Seodaemun-gu, 03772
United Kingdom2 sites
Beatson, West of Scotland Cancer Centre
Glasgow, G12 0YN
The Christie NHS Foundation Trust
Withington, Manchester Greater, M204BX
About this study
Official title: A Phase 1-2, First-in-Human Study of CX-2029 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029)
The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). The antitumor activity of CX-2029 will be evaluated in subjects with head and neck squamous cell carcinoma (HNSCC), DLBCL, non-small cell lung cancer (NSCLC) (squamous cell histology only), or esophageal (esophageal adenocarcinoma [EAC], esophageal squamous cell carcinoma [ESCC], or gastroesophageal [GE] junction) cancer.
PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc
Read the detailed description
This is an open-label, Phase 1-2, first-in-human study for CX-2029 in subjects with metastatic or locally advanced unresectable solid tumors or Diffuse large B-cell lymphoma (DLBCL) without approved life-prolonging treatment options for their malignancy.
The study is divided into 3 parts (arms), as follows:
- Part A: Dose escalation and determination of the Maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D)
- Part B: Characterization of CX-2029 in the Tumor microenvironment (TME) in subjects with select tumor types using previously cleared dose levels from Part A
- Part C: Expansions in select tumor types at the MTD/RP2D as established in Part A
- Conditions
- Solid Tumor, Adult, Head and Neck Cancer, Non Small Cell Lung Cancer, Diffuse Large B Cell Lymphoma, Esophageal Cancer
- Being tested
- CX-2029
- Keywords
- cancer, solid tumor, DLBCL, CX-2029, PROBODY™ Therapeutic, Drug Conjugate, Antibody drug conjugate, CD71, Transferrin receptor 1
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Lymphoma, Large B-Cell, Diffuse, Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-2029Drug
CX-2029 Monotherapy
| Study group | Role | What they receive |
|---|---|---|
| CX-2029 Escalation | Experimental | Dose Escalation and Determination Receives: Drug: CX-2029 |
| CX-2029 Biomarker | Experimental | Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types Receives: Drug: CX-2029 |
| CX-2029 Expansion | Experimental | Evaluate antitumor activity of CX-2029 Receives: Drug: CX-2029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-2029 as a monotherapy
Measured: 21 days (dose-limiting toxicity period)
Secondary outcomes (1)
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start15 Jun 2018
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytomX Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Vainorius, M.D., Study director, CytomX Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543813
- Sponsor's protocol ID
- CTMX-M-2029-001
- Status last verified
- Jan 2024
- First submitted
- 21 May 2018
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2, First-in-Human Study of CX-2029 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029)
- ClinicalTrials.gov ID
- NCT03543813
- Acronym / sponsor ID
- CTMX-M-2029-001
- Conditions
- Solid Tumor, Adult, Head and Neck Cancer, Non Small Cell Lung Cancer, Diffuse Large B Cell Lymphoma, Esophageal Cancer
- Keywords
- cancer, solid tumor, DLBCL, CX-2029, PROBODY™ Therapeutic, Drug Conjugate, Antibody drug conjugate, CD71
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- CytomX TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this first-in-human study of CX-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). The antitumor activity of CX-2029 will be evaluated in subjects with head and neck squamous cell carcinoma (HNSCC), DLBCL, non-small cell lung cancer (NSCLC) (squamous cell histology only), or esophageal (esophageal adenocarcinoma [EAC], esophageal squamous cell carcinoma [ESCC], or gastroesophageal [GE] junction) cancer.
PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc
Detailed description
This is an open-label, Phase 1-2, first-in-human study for CX-2029 in subjects with metastatic or locally advanced unresectable solid tumors or Diffuse large B-cell lymphoma (DLBCL) without approved life-prolonging treatment options for their malignancy.
The study is divided into 3 parts (arms), as follows:
- Part A: Dose escalation and determination of the Maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D)
- Part B: Characterization of CX-2029 in the Tumor microenvironment (TME) in subjects with select tumor types using previously cleared dose levels from Part A
- Part C: Expansions in select tumor types at the MTD/RP2D as established in Part A
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CX-2029 Escalation | Experimental | Drug: CX-2029Dose Escalation and Determination |
| CX-2029 Biomarker | Experimental | Drug: CX-2029Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types |
| CX-2029 Expansion | Experimental | Drug: CX-2029Evaluate antitumor activity of CX-2029 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
- Patients demonstrating disease progression after treatment with approved therapies that are known to confer life-prolonging benefit, or who are intolerant to or have declined treatment
- Agreement to provide mandatory archival tissue or fresh biopsy
- At least 18 years of age
- For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
Key exclusion criteria (13 listed)
- Neuropathy > Grade 1
- Serious concurrent illness, including clinically relevant active infection
- Clinically significant iron metabolism disorders (eg, sickle cell anemia)
- Significant cardiac disease such as recent myocardial infarction
- History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX-2029CX-2029 Monotherapy | Drug | CX-2029 Biomarker, CX-2029 Escalation, CX-2029 Expansion |
Primary outcome
The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-2029 as a monotherapy
Time frame: 21 days (dose-limiting toxicity period)
1 secondary outcome
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Vainorius, M.D. study director
CytomX Therapeutics, Inc.
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CX-2029 in people with Solid Tumor, Adult and Head and Neck Cancer, run by CytomX Therapeutics at 25 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 7 inclusion and 13 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 25 sites in United States, Spain, South Korea, United Kingdom. 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 combined 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.
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?
The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-2029 as a monotherapy (time frame: 21 days (dose-limiting toxicity period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.