Biliary CancerPhase 1/2NCT05849480
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
A Phase 1/2 study testing oxaliplatin, capecitabine and Keytruda in people with Biliary Cancer and Bile Duct Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Biliary tract carcinoma (BTC) is cancer of the slender tubes that carry fluids in the liver. People with advanced BTC have few treatment options, and their survival rates are very low. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Biliary Cancer, Bile Duct Cancer, Cancer of the Bile Duct
- What is being tested?
- oxaliplatin, capecitabine and Keytruda
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to 1 Jun 2042
- Phase
- Phase 1/2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of BTC.
- The maximum tumor size of any individual tumor or metastasis must be <= 8 cm.
- Participants should have progressed on standard of care first line systemic treatment or refused standard treatment.
- Participants must have a disease that is not amenable to potentially curative resection or liver transplantation.
- Participants must have evaluable or measurable disease per RECIST 1.1
- ECOG performance status of 0 to 1
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- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count
- (ANC) >= 1,000/mcL
- Platelets >= 100,000/mcL
- Total bilirubin <= 2.5 x ULN
- ALT and AST <= 5 x ULN.
- Creatinine OR Measured or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl)
- <1.5x institution upper limit of normal OR
- >= 45 mL/min/1.73 m2 for participant with creatinine levels
- >= 1.5 X institutional ULN
- Age >=18 years.
- Participants must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be <= grade 1. Note: participants with thyroid dysfunction caused by prior therapy including the need for chronic therapy are eligible.
- Individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) at the study entry, for the duration of study treatment and up to 4 months after the last dose of the CDX-1140 or Keytruda(R) (all individuals), 9 months (IOCBP), 6 months (individuals able to father a child) after completion of CAPOX therapy whatever comes later
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after study treatment discontinuation.
- HBV-infected participants must be on antivirals and have HBV DNA <100 IU/mL. HCV-infected participants can be enrolled if HCV RNA level is undetectable.
- Participants must be able to understand and willing to sign a written informed consent document.
Who cannot join
- History of a homozygous or compound heterozygous variants in the DPYD gene associated with complete or near complete absence in dihydropyridimidine dehydrogenase (DPD) activity.
- Participants who have had standard-of-care anti-cancer therapy or therapy with investigational agents (e.g., chemotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigation agents) or large field radiotherapy within 4 weeks prior to treatment initiation.
- Prior therapy with anti- CD40.
- Receiving of live vaccines within 30 days prior to the treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist(R)) are live attenuated vaccines and are not allowed.
- Major surgery within 4 weeks prior to treatment initiation.
- Active central nervous system metastases and/or carcinomatous meningitis.
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- HIV-infected participants.
- History of (non-infectious) pneumonitis or current pneumonitis.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or other agents used in study, such as nivolumab, dacetuzumab, APX005M, ADC-1013.
- Prior invasive malignancies within the past 3 years prior to treatment initiation (with the exception of non-melanoma skin cancers, non-invasive bladder cancer, or localized prostate cancer for whom systemic therapy is not required).
- Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted).
- History of chronic autoimmune disease (e.g., Addison's disease, multiple sclerosis, Graves' disease, Hashimoto's thyroiditis, rheumatoid arthritis, hypophysitis, systemic lupus erythematosus, Wegener's granulomatosis, sarcoidosis syndrome, etc.) or other connective tissue diseases with the symptomatic disease within the 3 years of initiation of study treatment. Note: Active vitiligo or a history of vitiligo will not be a basis for exclusion.
- Fridericia's corrected QT interval (QTcF) >= 480 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.
- Participants who were not able to tolerate prior immune checkpoint inhibitor therapy.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: A Phase I/II Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Background:
Biliary tract carcinoma (BTC) is cancer of the slender tubes that carry fluids in the liver. People with advanced BTC have few treatment options, and their survival rates are very low.
Read more
Objective:
To test a study drug (CDX-1140) combined 3 other drugs (capecitabine, oxaliplatin, Keytruda) in people with BTC.
Eligibility:
Adults aged 18 years or older with BTC that progressed after treatment and is not eligible for surgery or liver transplant.
Design:
Participants will be screened. They will have a physical exam. They will have blood tests and tests of their heart function. They will have imaging scans. They may need to have a biopsy: A small sample of tissue will be taken from their tumor using a small needle.
Three of the drugs are given through a tube attached to a needle inserted into a vein in the arm (intravenous). The fourth drug is a pill taken by mouth with water.
Participants will be treated in 21-day cycles. They will receive intravenous treatments on day 1 and day 8 of the first 6 cycles. After that, they will receive intravenous treatments only on day 1 of each cycle.
Participants will take the pill twice a day only for the first 2 weeks of each cycle. They will stop taking this drug after 6 cycles.
Imaging scans will be repeated every 9 weeks.
Participants may continue receiving the study treatment for up to 2 years. Follow-up visits, including imaging scans, will continue for 3 more years. These images may be taken at other locations and sent to the researchers.
Read the detailed description
Background:
Advanced biliary tract carcinoma (BTC) has limited treatment options in the second line setting and a dismal prognosis.
Capecitabine and oxaliplatin (CAPOX) in combination with Keytruda(R) is a tolerable and potentially effective treatment for individuals with refractory advanced BTC.
Programmed cell death protein 1 (PD-1) is an inhibitory receptor that is expressed by all Tcells during activation. It regulates T-cell effector functions during various physiological responses, including acute and chronic infection, cancer and autoimmunity, and immune
homeostasis. Keytruda(R) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of different cancers including individuals with hepatocellular carcinoma.
CD40-mediated activation of macrophages and dendritic cells (DC)s in intrahepatic cholangiocarcinoma (iCCA) significantly improves response to anti-PD-1 therapy in preclinical studies. The efficacy of this regimen is enhanced by first-line chemotherapy,
supporting the potential antitumor efficacy of the combination of CD40 agonist antibody (anti-CD40) with anti-PD-1 and chemotherapy.
Objectives:
Phase I: To estimate safe dose of CDX-1140 used in combination with CAPOX, and Keytruda(R)
Phase II:
To evaluate the 6-month progression free survival (PFS) in participants with advanced BTC treated with CDX-1140, CAPOX, and Keytruda(R).
To determine the overall response rate (ORR) defined as complete response (CR) + partial response (PR) according to RECIST 1.1 in participants with advanced BTC.
Eligibility:
Histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology,are highly suggestive of a diagnosis of BTC
Age >=18 years
Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Design:
Phase I/II, single-arm, non-randomized trial of Keytruda(R) and CDX-1140 in combination with CAPOX in participants with BTC in the second-line setting.
Initially, 9-12 participants will be enrolled into a Phase I portion of the trial. If safe, we will continue enrollment as planned into Phase II, if not, we will close the protocol.
After estimation of CDX-1140 recommended phase II dose, the first 13 participants enrolled at this dose level of CDX-1140 in Phase I and Phase II will be evaluated for progression. If among these 13 participants, no more than 2 can be progression-free at the 6-months evaluation, then no further participants will be enrolled as soon as this can be determined.
- Conditions
- Biliary Cancer, Bile Duct Cancer, Cancer of the Bile Duct
- Being tested
- oxaliplatin, capecitabine, Keytruda, CDX-1140
- Keywords
- Immunotherapy, Pembrolizumab, CAPOX, CDX-1140, CD40 agonist
- Medical subject headings
- Biliary Tract Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
Oxaliplatin (130 mg/m2) will be administered IV on Day 1 of each cycle, every 21 days (up to 6 cycles).
capecitabineDrug
Capecitabine (750 mg/m2 every 12 hours) will be administered orally with an intermittent schedule: 2 weeks on, 1 week off, of each cycle, every 21 days (up to 6 cycles).
KeytrudaBiological
Pembrolizumab (200 mg) will be given IV on Day 8 of each cycle every 21 days (up to 6 cycles).
CDX-1140Biological
CDX-1140 (0.36-1.5 mg/kg; per assigned dose level) will be given IV on Day 8 of each cycle every 21 days (up to 6 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Keytruda, oxaliplatin, capecitabine and escalating doses of CDX-1140 Receives: Drug: oxaliplatin; Drug: capecitabine; Biological: Keytruda; Biological: CDX-1140 |
| Phase II | Experimental | Keytruda, oxaliplatin, capecitabine and estimated safe dose of CDX-1140 Receives: Drug: oxaliplatin; Drug: capecitabine; Biological: Keytruda; Biological: CDX-1140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Safe dose of CDX-1140 in combination with CAPOX and Keytruda(R)
Estimation of safe dose will be determined based on number of dose limiting toxicities (DLTs) experienced.
Measured: 35 days
Phase II: 6-month progression free survival (PFS) probability
6-month PFS probability will be calculated using the Kaplan-Meier method.
Measured: Study start - 6 months after start of study drug
Phase II: Overall response rate (ORR)
The fraction of participants who experience a response (PR + CR) evaluated every 9 (+/- 4) weeks. Results will be reported along with 80% and 95% two-sided confidence intervals.
Measured: Study start until disease progression or 5 years after initiation of study therapy, whichever occurs first.
Secondary outcomes (2)
Safety of CDX-1140, CAPOX and Keytruda(R) in participants with advanced BTC as determined by toxicities experienced
Any adverse events/toxicities identified will be reported by type and grade.
Measured: Day 1 of Cycle 1 through 90 days after the study agents were last administered
5-year overall survival
Participants will be assessed for survival at study visits while on study therapy and annually thereafter.
Measured: Study start - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start8 May 2024
- Primary completion1 Jun 2040 (estimated)
- Study completion1 Jun 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tim F Greten, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849480
- Sponsor's protocol ID
- 10001548
- Other IDs
- 001548-C
- Status last verified
- 23 Oct 2026
- First submitted
- 8 May 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
- ClinicalTrials.gov ID
- NCT05849480
- Acronym / sponsor ID
- 10001548
- Conditions
- Biliary Cancer, Bile Duct Cancer, Cancer of the Bile Duct
- Keywords
- Immunotherapy, Pembrolizumab, CAPOX, CDX-1140, CD40 agonist
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Jun 2040 (estimated)
- Study completion
- 1 Jun 2042 (estimated)
- First posted
- 9 May 2023 (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.
Background:
Biliary tract carcinoma (BTC) is cancer of the slender tubes that carry fluids in the liver. People with advanced BTC have few treatment options, and their survival rates are very low.
Objective:
To test a study drug (CDX-1140) combined 3 other drugs (capecitabine, oxaliplatin, Keytruda) in people with BTC.
Eligibility:
Adults aged 18 years or older with BTC that progressed after treatment and is not eligible for surgery or liver transplant.
Design:
Participants will be screened. They will have a physical exam. They will have blood tests and tests of their heart function. They will have imaging scans. They may need to have a biopsy: A small sample of tissue will be taken from their tumor using a small needle.
Three of the drugs are given through a tube attached to a needle inserted into a vein in the arm (intravenous). The fourth drug is a pill taken by mouth with water.
Participants will be treated in 21-day cycles. They will receive intravenous treatments on day 1 and day 8 of the first 6 cycles. After that, they will receive intravenous treatments only on day 1 of each cycle.
Participants will take the pill twice a day only for the first 2 weeks of each cycle. They will stop taking this drug after 6 cycles.
Imaging scans will be repeated every 9 weeks.
Participants may continue receiving the study treatment for up to 2 years. Follow-up visits, including imaging scans, will continue for 3 more years. These images may be taken at other locations and sent to the researchers.
Detailed description
Background:
Advanced biliary tract carcinoma (BTC) has limited treatment options in the second line setting and a dismal prognosis.
Capecitabine and oxaliplatin (CAPOX) in combination with Keytruda(R) is a tolerable and potentially effective treatment for individuals with refractory advanced BTC.
Programmed cell death protein 1 (PD-1) is an inhibitory receptor that is expressed by all Tcells during activation. It regulates T-cell effector functions during various physiological responses, including acute and chronic infection, cancer and autoimmunity, and immune
homeostasis. Keytruda(R) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of different cancers including individuals with hepatocellular carcinoma.
CD40-mediated activation of macrophages and dendritic cells (DC)s in intrahepatic cholangiocarcinoma (iCCA) significantly improves response to anti-PD-1 therapy in preclinical studies. The efficacy of this regimen is enhanced by first-line chemotherapy,
supporting the potential antitumor efficacy of the combination of CD40 agonist antibody (anti-CD40) with anti-PD-1 and chemotherapy.
Objectives:
Phase I: To estimate safe dose of CDX-1140 used in combination with CAPOX, and Keytruda(R)
Phase II:
To evaluate the 6-month progression free survival (PFS) in participants with advanced BTC treated with CDX-1140, CAPOX, and Keytruda(R).
To determine the overall response rate (ORR) defined as complete response (CR) + partial response (PR) according to RECIST 1.1 in participants with advanced BTC.
Eligibility:
Histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology,are highly suggestive of a diagnosis of BTC
Age >=18 years
Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Design:
Phase I/II, single-arm, non-randomized trial of Keytruda(R) and CDX-1140 in combination with CAPOX in participants with BTC in the second-line setting.
Initially, 9-12 participants will be enrolled into a Phase I portion of the trial. If safe, we will continue enrollment as planned into Phase II, if not, we will close the protocol.
After estimation of CDX-1140 recommended phase II dose, the first 13 participants enrolled at this dose level of CDX-1140 in Phase I and Phase II will be evaluated for progression. If among these 13 participants, no more than 2 can be progression-free at the 6-months evaluation, then no further participants will be enrolled as soon as this can be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: oxaliplatin, Drug: capecitabine, Biological: Keytruda, Biological: CDX-1140Keytruda, oxaliplatin, capecitabine and escalating doses of CDX-1140 |
| Phase II | Experimental | Drug: oxaliplatin, Drug: capecitabine, Biological: Keytruda, Biological: CDX-1140Keytruda, oxaliplatin, capecitabine and estimated safe dose of CDX-1140 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Participants must have histopathological confirmation of BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of BTC.
- The maximum tumor size of any individual tumor or metastasis must be <= 8 cm.
- Participants should have progressed on standard of care first line systemic treatment or refused standard treatment.
- Participants must have a disease that is not amenable to potentially curative resection or liver transplantation.
- Participants must have evaluable or measurable disease per RECIST 1.1
Key exclusion criteria (16 listed)
- History of a homozygous or compound heterozygous variants in the DPYD gene associated with complete or near complete absence in dihydropyridimidine dehydrogenase (DPD) activity.
- Participants who have had standard-of-care anti-cancer therapy or therapy with investigational agents (e.g., chemotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigation agents) or large field radiotherapy within 4 weeks prior to treatment initiation.
- Prior therapy with anti- CD40.
- Receiving of live vaccines within 30 days prior to the treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist(R)) are live attenuated vaccines and are not allowed.
- Major surgery within 4 weeks prior to treatment initiation.
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 |
|---|---|---|
| oxaliplatinOxaliplatin (130 mg/m2) will be administered IV on Day 1 of each cycle, every 21 days (up to 6 cycles). | Drug | Phase I, Phase II |
| capecitabineCapecitabine (750 mg/m2 every 12 hours) will be administered orally with an intermittent schedule: 2 weeks on, 1 week off, of each cycle, every 21 days (up to 6 cycles). | Drug | Phase I, Phase II |
| KeytrudaPembrolizumab (200 mg) will be given IV on Day 8 of each cycle every 21 days (up to 6 cycles). | Biological | Phase I, Phase II |
| CDX-1140CDX-1140 (0.36-1.5 mg/kg; per assigned dose level) will be given IV on Day 8 of each cycle every 21 days (up to 6 cycles). | Biological | Phase I, Phase II |
Primary outcome
Phase I: Safe dose of CDX-1140 in combination with CAPOX and Keytruda(R)
Time frame: 35 days
Estimation of safe dose will be determined based on number of dose limiting toxicities (DLTs) experienced.
Phase II: 6-month progression free survival (PFS) probability
Time frame: Study start - 6 months after start of study drug
6-month PFS probability will be calculated using the Kaplan-Meier method.
Phase II: Overall response rate (ORR)
Time frame: Study start until disease progression or 5 years after initiation of study therapy, whichever occurs first.
The fraction of participants who experience a response (PR + CR) evaluated every 9 (+/- 4) weeks. Results will be reported along with 80% and 95% two-sided confidence intervals.
2 secondary outcomes
Safety of CDX-1140, CAPOX and Keytruda(R) in participants with advanced BTC as determined by toxicities experienced
Time frame: Day 1 of Cycle 1 through 90 days after the study agents were last administered
5-year overall survival
Time frame: Study start - 5 years
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 30 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
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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.
Tim F Greten, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing oxaliplatin, capecitabine and Keytruda in people with Biliary Cancer and Bile Duct Cancer, run by National Cancer Institute (NCI) at 1 site 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 22 inclusion and 16 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
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 Donna Hrones, C.R.N.P. ((240) 858-3155, donna.mabry@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Safe dose of CDX-1140 in combination with CAPOX and Keytruda(R) (time frame: 35 days). The study lists 3 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 30 Oct 2026.