Solid Tumor, AdultPhase 1NCT06265688
First In Human Study of CX-2051 in Advanced Solid Tumors
A Phase 1 study testing CX-2051 and Bevacizumab in people with Solid Tumor, Adult, run by CytomX Therapeutics at 8 sites in United States.
Trial summary
The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- CX-2051 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Apr 2024to 31 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Measurable disease per RECIST v1.1
- Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
- Additional inclusion criteria may apply
Who cannot join
- Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
- Known active central nervous system (CNS) involvement by malignancy
- Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1
- Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload
- Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1
- Elevated baseline laboratory values
Show all 9Show fewer
- Serious concurrent illness
- Pregnant or breast feeding
- Additional exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
START - Dallas/Fort Worth
Fort Worth, Texas, 76104
- Recruiting
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, 28078
- Recruiting
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, 37203
- Recruiting
START San Antonio LLC
San Antonio, Texas, 78229
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors
The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors.
Read the detailed description
The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051 as monotherapy and as combination therapy (CX-2051 combined with bevacizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 as monotherapy and/or combination therapy in indication-specific expansion cohorts.
- Conditions
- Solid Tumor, Adult
- Being tested
- CX-2051, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-2051Drug
Investigational drug
BevacizumabDrug
Also called Avastin
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| CX-2051 | Experimental | Not described Receives: Drug: CX-2051 |
| CX-2051 + bevacizumab | Experimental | Not described Receives: Drug: CX-2051; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CX-2051
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Measured: 44 months
Determine the recommended Phase 2 dose (RP2D)
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Measured: 44 months
Secondary outcomes (7)
Objective response rate (ORR)
ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment
Measured: 60 months
Duration of response (DOR)
DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Measured: 60 months
Progression-free survival (PFS)
PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: 60 months
Time to Treatment Failure (TTF)
TTF defined as the time from first dose of study intervention to the date of premature discontinuation for any reason, including tumor progression, severe toxicity, participant withdrawal, or death.
Measured: 60 months
Disease control rate (DCR)
DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.
Measured: 60 months
Duration of disease control (DODC)
DODC defined as the time from the first documentation of confirmed CR, PR, or SD (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
Measured: 60 months
Overall survival (OS)
OS defined as the time from the first dose of study intervention to death due to any cause
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Apr 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytomX Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Vainorius, MD, Study director, CytomX Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265688
- Sponsor's protocol ID
- CTMX-2051-101
- Status last verified
- Jul 2026
- First submitted
- 12 Feb 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06265688
- Acronym / sponsor ID
- CTMX-2051-101
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- CytomX TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 20 Feb 2024 (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, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab in adult participants with advanced solid tumors.
Detailed description
The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051 as monotherapy and as combination therapy (CX-2051 combined with bevacizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 as monotherapy and/or combination therapy in indication-specific expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CX-2051 | Experimental | Drug: CX-2051 |
| CX-2051 + bevacizumab | Experimental | Drug: CX-2051, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Measurable disease per RECIST v1.1
- Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
- Additional inclusion criteria may apply
Key exclusion criteria (9 listed)
- Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
- Known active central nervous system (CNS) involvement by malignancy
- Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1
- Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload
- Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1
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-2051Investigational drug | Drug | CX-2051, CX-2051 + bevacizumab |
| BevacizumabAlso: AvastinIV infusion | Drug | CX-2051 + bevacizumab |
Primary outcome
Safety and tolerability of CX-2051
Time frame: 44 months
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
Determine the recommended Phase 2 dose (RP2D)
Time frame: 44 months
The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level
7 secondary outcomes
Objective response rate (ORR)
Time frame: 60 months
Duration of response (DOR)
Time frame: 60 months
Progression-free survival (PFS)
Time frame: 60 months
Time to Treatment Failure (TTF)
Time frame: 60 months
Disease control rate (DCR)
Time frame: 60 months
Duration of disease control (DODC)
Time frame: 60 months
Overall survival (OS)
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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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.
Monika Vainorius, MD study director
CytomX Therapeutics
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CX-2051 and Bevacizumab in people with Solid Tumor, Adult, run by CytomX Therapeutics at 8 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 5 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Deane (650-515-3185, clinicaltrials@cytomx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of CX-2051 (time frame: 44 months). 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?
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 15 Jul 2026.