Solid Tumor, AdultPhase 1/2NCT03149549

PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

A Phase 1/2 study testing CX-2009 in people with Solid Tumor, Adult and Breast Cancer, run by CytomX Therapeutics at 26 sites in 4 countries.

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 first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer
What is being tested?: CX-2009
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 26 sitesin 4 countries
Study dates: 1 Jun 2017to 10 Sep 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 confirmed diagnosis of metastatic or locally advanced unresectable tumors
Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
Agreement to provide mandatory archival tissue or fresh biopsy.
At least 18 years of age.

Who cannot join

Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
Serious concurrent illness, including clinically relevant active infection
History of or current active autoimmune diseases
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;

Show all 9Show fewer

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.

Trial locations and contacts

26 sites in 4 countries.

Country

City, postcode or hospital

26 sites in 4 countries

United States16 sites

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Viriginia Cancer Specialists
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Wisconsin-Carbone Cancer Center
Madison, Wisconsin, 53579
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, 06520
New York University (NYU) Clinical Cancer Center
New York, New York, 10016
Columbia University College of Physicians & Surgeons, Columbia University
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Providence Portland Medical Center
Portland, Oregon, 97213
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Swedish Cancer Institute (SCI)
Seattle, Washington, 98104

Other trials in United States

Spain5 sites

Instituto Catalan de Oncologia - Hospital Duran i Reynals
Barcelona, 08908
Hospital Clinic Barcelona
Barcelona, 8036
Centro Integral Oncologico Clara Campal
Madrid, 28050
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Instituto Valenciano de Oncologia
Valencia, 46009

Other trials in Spain

United Kingdom3 sites

Beatson, West of Scotland Cancer Centre
Glasgow, G12 0YN
Sarah Cannon Research Institute UK Limited
London, W1G 6AD
Northern Centre for Cancer Care
Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Netherlands2 sites

Amsterdam UMC - Locatie VUmc
Amsterdam, 1007
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

PROBODY is a trademark of CytomX Therapeutics, Inc

Conditions: Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer, Ovarian Cancer
Being tested: CX-2009
Keywords: cancer, solid tumor, PROCLAIM, CX-2009, PROBODY™ Therapeutic, Drug Conjugate, Antibody drug conjugate, CD166
Medical subject headings: Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Ovarian Neoplasms, Neoplasms

What participants receive

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

CX-2009Drug
CX-2009 Monotherapy

Study groups in NCT03149549
Study group	Role	What they receive
CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation	Experimental	Dose escalation and determination Receives: Drug: CX-2009
CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination	Experimental	Additional enrollment into previously cleared monotherapy dose levels Receives: Drug: CX-2009
CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion	Experimental	Dose expansion Receives: Drug: CX-2009
CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion	Experimental	Dose escalation and determination in selected tumor types Receives: Drug: CX-2009

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-2009 as a Monotherapy
All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.
Measured: 21 days for the Q3W schedule, 28 days for the Q2W schedule

Secondary outcomes (1)

Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy
Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol.
>
> For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per
> RECIST Version 1.1
Measured: Median total on-study follow-up of 18.4 weeks.

Timeline

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

1 Jun 201710 Sep 2020

First posted11 May 2017
Study start1 Jun 2017
Primary completion10 Sep 2020
Study completion10 Sep 2020

Why it stopped: Covid Pandemic; Business Decision to separate Phase 2 to new study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03149549
Sponsor's protocol ID: CTMX-M-2009-001
Status last verified: Jan 2024
First submitted: 4 May 2017
Last updated: 5 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)
ClinicalTrials.gov ID: NCT03149549
Acronym / sponsor ID: CTMX-M-2009-001
Conditions: Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer, Ovarian Cancer
Keywords: cancer, solid tumor, PROCLAIM, CX-2009, PROBODY™ Therapeutic, Drug Conjugate, Antibody drug conjugate, CD166
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Covid Pandemic; Business Decision to separate Phase 2 to new study
Enrolment: 99 participants (actual)
Lead sponsor: CytomX TherapeuticsIndustry (pharma, biotech, devices)
Study start: 1 Jun 2017 (actual)
Primary completion: 10 Sep 2020 (actual)
Study completion: 10 Sep 2020 (actual)
First posted: 11 May 2017 (actual)
Results: Posted 5 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PROBODY is a trademark of CytomX Therapeutics, Inc

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation	Experimental	Drug: CX-2009Dose escalation and determination
CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination	Experimental	Drug: CX-2009Additional enrollment into previously cleared monotherapy dose levels
CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion	Experimental	Drug: CX-2009Dose expansion
CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion	Experimental	Drug: CX-2009Dose escalation and determination in selected tumor types

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
Agreement to provide mandatory archival tissue or fresh biopsy.
At least 18 years of age.

Key exclusion criteria (9 listed)

Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
Serious concurrent illness, including clinically relevant active infection
History of or current active autoimmune diseases
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-2009CX-2009 Monotherapy	Drug	CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion, CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination, CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation, CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion

Primary outcome

The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy
Time frame: 21 days for the Q3W schedule, 28 days for the Q2W schedule
All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.

1 secondary outcome

Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy
Time frame: Median total on-study follow-up of 18.4 weeks.

Results and safety

Results posted to the registry on 5 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A 0.25 mg/kg Q3W	1	1
A 0.5 mg/kg Q3W	3	3
A 1 mg/kg Q3W	3	3
A 2 mg/kg Q3W	3	1
A, A2 4 mg/kg Q3W	10	6
A, A2 5 mg/kg Q3W	9	7
A, A2 6 mg/kg Q3W	9	6
A, A2, B 7 mg/kg Q3W	12	8
A, A2 8 mg/kg Q3W	22	16
A, A2 9 mg/kg Q3W	9	7
A, A2 10 mg/kg Q3W	8	8
C1 4 mg/kg Q2W	4	4
C1 6 mg/kg Q2W	6	4

Primary outcome: The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy

Time frame: 21 days for the Q3W schedule, 28 days for the Q2W schedule. Count of participants. Unit: Participants

Measure	A 0.25 mg/kg Q3W n = 1	A 0.5 mg/kg Q3W n = 3	A 1 mg/kg Q3W n = 3	A 2 mg/kg Q3W n = 3	A, A2 4 mg/kg Q3W n = 10	A, A2 5 mg/kg Q3W n = 9	A, A2 6 mg/kg Q3W n = 9	A, A2, B 7 mg/kg Q3W n = 12	A, A2 8 mg/kg Q3W n = 22	A, A2 9 mg/kg Q3W n = 9	A, A2 10 mg/kg Q3W n = 8	C1 4 mg/kg Q2W n = 4	C1 6 mg/kg Q2W n = 6
Participants not experiencing DLTs	1	3	3	3	10	9	9	12	21	9	8	4	4
Participants experiencing DLT	0	0	0	0	0	0	0	0	1	0	0	0	2

Population analysed: A DLT-evaluable subject is defined as one having received at least 1 dose of CX-2009 (or CX 2009 and CX-072) and then having completed the full DLT observation period (either 21 or 28 days depending on the schedule), or one who subsequently withdrew due to a drug-related toxicity.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A 0.25 mg/kg Q3W	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Part A 0.5 mg/kg Q3W	0 of 3 (0%)	3 of 3 (100%)	3 of 3
Part A 1 mg/kg Q3W	0 of 3 (0%)	2 of 3 (66.7%)	3 of 3
Part A 2 mg/kg Q3W	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Parts A & A2 4 mg/kgQ3W (4 in Part A, 6 inPart A2)	2 of 10 (20%)	10 of 10 (100%)	6 of 10
Parts A & A2 5 mg/kgQ3W (3 in Part A, 6 inPart A2)	2 of 9 (22.2%)	9 of 9 (100%)	4 of 9
Parts A & A2 6 mg/kgQ3W (3 in Part A, 6 inPart A2)	3 of 9 (33.3%)	9 of 9 (100%)	6 of 9
Parts A, A2 & B 7mg/kg Q3W (3 in PartA, 6 in Part A2, 3 inPart B)	5 of 12 (41.7%)	12 of 12 (100%)	6 of 12
Parts A & A2 8 mg/kgQ3W (16 in Part A, 6 inPart A2)	10 of 22 (45.5%)	22 of 22 (100%)	13 of 22
Parts A & A2 9 mg/kgQ3W (3 in Part A, 6 inPart A2)	5 of 9 (55.6%)	9 of 9 (100%)	7 of 9
Parts A & A2 10 mg/kgQ3W (5 in Part A, 3 inPart A2)	3 of 8 (37.5%)	8 of 8 (100%)	6 of 8
Part C1 4 mg/kg Q2W	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Part C1 6 mg/kg Q2W	1 of 6 (16.7%)	6 of 6 (100%)	2 of 6

Limitations and caveats (from the sponsor): This study was terminated early due to the Covid Pandemic and the company's business decision to separate the Phase 2 (part B) course of the study to a separate, new Phase 2 study. The Phase 1 (part A) course of the study was completed and the RP2D was determined. Part B only enrolled 3 patients and the Secondary and other Outcomes were not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Solid Tumor, Adult

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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, MD study director

CytomX Therapeutics

26 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-2009 in people with Solid Tumor, Adult and Breast Cancer, run by CytomX Therapeutics at 26 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 9 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 5 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 26 sites in United States, Spain, United Kingdom, Netherlands. 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?

Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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-2009 as a Monotherapy (time frame: 21 days for the Q3W schedule, 28 days for the Q2W schedule). 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 NCT03149549.

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 5 Jan 2024.