Advanced Solid TumorPhase 1NCT07408258
Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors
A Phase 1 study testing ONC-783 in people with Advanced Solid Tumor, run by OncoC4, Inc. at 3 sites in United States.
Trial summary
ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ONC-783
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Aug 2026to 1 Aug 2028
- 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
- Age ≥ 18 yrs old.
- Male or Female
- Must have ECOG score ≤ 1. The body weight should be ≥40 kg. The life expectance should be estimated ≥ 12 weeks.
- A histological or cytological diagnosis of metastatic or locally advanced pancreatic cancer, ovarian cancer, colorectal cancer, or breast cancer.
- Must have measurable target lesion according to RECIST V1.1.
- Adequate organ function as determined by laboratory tests.
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- Voluntary agreement to participate as evidenced by written informed consent.
- Female patient of childbearing potential: negative pregnancy test and agreement on highly effective contraceptive methods.
- Male patient: agreement on contraceptive methods.
Who cannot join
- Patients who have not recovered to NCI CTCAE Grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the Grade ≤ 2 chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled Grade ≤ 2 endocrine immune-related AEs are considered stable and eligible for enrollment.
- The washout period for cancer therapeutic drugs (such as chemotherapy, radiation or targeted therapy) is 21 days or 28 days for monoclonal antibody therapy. Palliative radiotherapy for painful metastases or metastases in potentially sensitive locations (e.g., epidural space) ≥ 7 days prior to the first dose of study drug is allowed. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, growth factors and therapy for non-cancer conditions are allowed.
- Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment (except palliative bone-directed radiotherapy), immune therapy, or cytokine therapy or anticipated to require another antineoplastic therapy during the study.
- Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment.
- Patients who have active brain metastases or leptomeningeal metastases. Patients are eligible if brain metastases are adequately treated or not felt to require local treatment (i.e. < 10 mm asymptomatic) and patients are asymptomatic or neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment). Note: Patients with previously treated brain metastases may participate provided that they are radiologically stable, clinically stable, and not requiring steroid treatment within 14 days before the first dose of study treatment.
- Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.
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- Patient has history of Grade ≥3 allergic or hypersensitivity to SC injected medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.
- QTcF (QT interval corrected for heart rate using Fridericia formula) >480 msec on screening ECG
- Within past 6 months with history of significant cardiovascular events including acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, heart failure NYHA class III or IV, or revascularization procedures.
- Patients who have acute infections which require systemic IV drug treatments within 7 days prior to C1D1. Oral drug or prophylaxis treatment is allowed.
- Patients who, in the opinion of the treating Investigator, have a history or current evidence of any medical or psychiatric conditions that would limit their ability to comply with all aspects of the trial or on a therapy, or with a significant laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make study participation not in the best interest of the patient. Investigators should discuss the case with the Sponsor.
- Patients who are pregnant or breastfeeding, or who intend to become pregnant or father a child during the study or within 6 months after the last dosing of study drug.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Stephane Champiat, MD, PhD
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Aiwu Ruth He, MD, PhD
- Not yet recruiting
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Saya L Jacob, MD
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors
ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer.
Read the detailed description
This is a first in human study on a novel bispecific antibody, ONC-783, targeting cancer specific neoantigen CD24 on tumor cells and CD3 on T cells. CD24 is over-expressed in about 70% of solid tumors and hematological malignancies. CD24 overexpression is associated with poor prognosis. Cancer-specific neo-CD24 epitope will distinguish malignant CD24 from physiological CD24. This study is a multi-level dose escalation study with ONC-783 to test the safety, PK, and efficacy in patients with solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- ONC-783
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONC-783Drug
Also called Bispecific antibody against CD24 and CD3
ONC-783 is a bispecific humanized monoclonal antibody targeting CD24 and CD3.
| Study group | Role | What they receive |
|---|---|---|
| ONC-783 | Experimental | ONC-783 will be given by SC injection with designated dose levels at Day 1 of each cycle. The cycle 1 will be 28 days and the subsequent cycles will be once every 2 weeks. Receives: Drug: ONC-783 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 dose (RP2D)
Recommended Phase 2 dose of the study drug ONC-783
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start10 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoC4, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruth He, MD, PhD, Principal investigator, Columbia University Irving Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408258
- Sponsor's protocol ID
- ONC-783-001
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07408258
- Acronym / sponsor ID
- ONC-783-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- OncoC4, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 13 Feb 2026 (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.
ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer.
Detailed description
This is a first in human study on a novel bispecific antibody, ONC-783, targeting cancer specific neoantigen CD24 on tumor cells and CD3 on T cells. CD24 is over-expressed in about 70% of solid tumors and hematological malignancies. CD24 overexpression is associated with poor prognosis. Cancer-specific neo-CD24 epitope will distinguish malignant CD24 from physiological CD24. This study is a multi-level dose escalation study with ONC-783 to test the safety, PK, and efficacy in patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONC-783 | Experimental | Drug: ONC-783ONC-783 will be given by SC injection with designated dose levels at Day 1 of each cycle. The cycle 1 will be 28 days and the subsequent cycles will be once every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 yrs old.
- Male or Female
- Must have ECOG score ≤ 1. The body weight should be ≥40 kg. The life expectance should be estimated ≥ 12 weeks.
- A histological or cytological diagnosis of metastatic or locally advanced pancreatic cancer, ovarian cancer, colorectal cancer, or breast cancer.
- Must have measurable target lesion according to RECIST V1.1.
Key exclusion criteria (12 listed)
- Patients who have not recovered to NCI CTCAE Grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the Grade ≤ 2 chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled Grade ≤ 2 endocrine immune-related AEs are considered stable and eligible for enrollment.
- The washout period for cancer therapeutic drugs (such as chemotherapy, radiation or targeted therapy) is 21 days or 28 days for monoclonal antibody therapy. Palliative radiotherapy for painful metastases or metastases in potentially sensitive locations (e.g., epidural space) ≥ 7 days prior to the first dose of study drug is allowed. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, growth factors and therapy for non-cancer conditions are allowed.
- Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment (except palliative bone-directed radiotherapy), immune therapy, or cytokine therapy or anticipated to require another antineoplastic therapy during the study.
- Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment.
- Patients who have active brain metastases or leptomeningeal metastases. Patients are eligible if brain metastases are adequately treated or not felt to require local treatment (i.e. < 10 mm asymptomatic) and patients are asymptomatic or neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment). Note: Patients with previously treated brain metastases may participate provided that they are radiologically stable, clinically stable, and not requiring steroid treatment within 14 days before the 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 |
|---|---|---|
| ONC-783Also: Bispecific antibody against CD24 and CD3ONC-783 is a bispecific humanized monoclonal antibody targeting CD24 and CD3. | Drug | ONC-783 |
Primary outcome
Recommended Phase 2 dose (RP2D)
Time frame: 24 Months
Recommended Phase 2 dose of the study drug ONC-783
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 8 Sep 2026.
- 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.
Ruth He, MD, PhD principal investigator
Columbia University Irving Cancer Center
3 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 ONC-783 in people with Advanced Solid Tumor, run by OncoC4, Inc. at 3 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 9 inclusion and 12 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Pan Zheng, MD, PhD ((202) 751-6823, pzheng@oncoc4.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 dose (RP2D) (time frame: 24 Months). 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 8 Sep 2026.