Solid Tumor, AdultPhase 1NCT06462794
First In Human Study of CX-801 in Advanced Solid Tumors
A Phase 1 study testing CX-801 and pembrolizumab in people with Solid Tumor, Adult, run by CytomX Therapeutics at 5 sites in United States.
Trial summary
The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab 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-801 and pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Aug 2024to 30 Jun 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
- Adequate organ function
- 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
- Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event
- Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment
- Investigational drug or device within 4 weeks prior to first dose of study treatment
- Radiation within 2 weeks prior to first dose of study treatment
Show all 9Show fewer
- Serious concurrent illness
- Pregnant or breast feeding
- Additional exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
- Recruiting
START Dallas Fort Worth, LLC
Fort Worth, Texas, 76104
- Recruiting
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, 90025
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
University of Pittsburgh Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.
Read the detailed description
The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.
- Conditions
- Solid Tumor, Adult
- Being tested
- CX-801, pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-801Drug
Investigational drug
pembrolizumabDrug
Also called KEYTRUDA®
Standard of Care Therapy
| Study group | Role | What they receive |
|---|---|---|
| CX-801 | Experimental | Not described Receives: Drug: CX-801 |
| CX-801 + pembrolizumab | Experimental | Not described Receives: Drug: CX-801; Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CX-801 as monotherapy and combination therapy
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 (6)
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
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 posted17 Jun 2024
- Study start28 Aug 2024
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Jun 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
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytomX Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Monika Vainorius, MD, Study director, CytomX Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462794
- Sponsor's protocol ID
- CTMX-801-101
- Other IDs
- KEYNOTE-F95, MK-3475-F95
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2024
- Last updated
- 28 Aug 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors
- ClinicalTrials.gov ID
- NCT06462794
- Acronym / sponsor ID
- CTMX-801-101
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- CytomX TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Jun 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-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.
Detailed description
The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 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-801 | Experimental | Drug: CX-801 |
| CX-801 + pembrolizumab | Experimental | Drug: CX-801, Drug: pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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
- Adequate organ function
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
- Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event
- Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment
- Investigational drug or device within 4 weeks prior to first dose of study treatment
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-801Investigational drug | Drug | CX-801, CX-801 + pembrolizumab |
| pembrolizumabAlso: KEYTRUDA®Standard of Care Therapy | Drug | CX-801 + pembrolizumab |
Primary outcome
Safety and tolerability of CX-801 as monotherapy and combination therapy
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
6 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
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 28 Aug 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
5 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-801 and pembrolizumab in people with Solid Tumor, Adult, run by CytomX Therapeutics at 5 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 6 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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-801 as monotherapy and combination therapy (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 28 Aug 2026.