Advanced Solid TumorPhase 1NCT06352359
Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
A Phase 1 study testing ONC-841 in people with Advanced Solid Tumor, run by OncoC4, Inc. at 8 sites in United States.
Trial summary
This is a Phase I/II open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841. 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-841
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Aug 2024to 30 Sep 2027
- 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
- Must have ECOG score ≤ 1. The body weight should be ≥40 kg.
- A histological or cytological diagnosis of solid tumors and metastatic disease or locally advanced disease.
- Must have measurable target lesion according to RECIST V1.1.
- Adequate organ function as determined by laboratory tests.
- Voluntary agreement to participate as evidenced by written informed consent.
- Female patient: negative pregnancy test and agreement on contraceptive methods.
- Male patient: agreement on contraceptive methods.
- Agree to give archival or other diagnostic tissue recut slides or an optional new tumor biopsy.
Who cannot join
- Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment.
- The washout period for cancer therapeutic drugs should be 5 half-life or 21 days for chemotherapy, whichever is shorter; 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. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion 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 who have active brain metastases or leptomeningeal metastases. Patients are eligible if brain metastases are adequately treated, 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 they are radiologically stable (i.e. no evidence of progression for ≥4 weeks by repeat imaging performed during study screening), 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 IV infusion medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.
- Within past 6 months with history of significant cardiovascular acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, revascularization procedures, acute pulmonary embolism or any disorders resulted in LVEF < 40% at the time of screening or colitis, small bowel obstruction, hepatitis or pancreatitis adrenal insufficiency, or severe immunotherapy related AE (irAE≥ grade 3).
- Patients who have acute infections which require systemic treatments within 14 days prior to C1D1.
- Patients who, in the opinion of the treating Investigator, have a history or current evidence of any condition, therapy, or 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, in the opinion of the treating Investigator. Investigators should discuss the case with the Sponsor and/or study leaders.
- Patients with known psychiatric or substance abuse disorders may interfere with cooperation with the requirements of the trial.
- Patients who are pregnant or breastfeeding or plan pregnancy or fathering the child during the study or within 6 months after the last dosing of study drug
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Imaan Khan, MD contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Rogel Cancer Center, University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
UF Health Cancer Center, University of Florida
Gainesville, Florida, 32610
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 770360
- Recruiting
AdventHealth Medical Group Oncology Research at Celebration
Kissimmee, Florida, 34747
- Recruiting
Norton Cancer Center
Louisville, Kentucky, 40202
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
- Recruiting
University of California at Davis Cancer Center
Sacramento, California, 95817
- Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
About this study
This is a Phase I/II open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.
Read the detailed description
ONC-841 is an investigational drug being developed as an anti-tumor treatment. ONC-841 is an antibody drug that binds to immune cells inside the tumor mass. The target molecule is Siglec10, mostly expressed on neutrophils, macrophages and lymphocytes. ONC-841 binds to Siglec10 to block the "do not eat me" signals that cancer cells give to immune system, which allow macrophages and neutrophils to "eat" the tumor cells. The study will use ONC-841 alone for cancer treatment. The study will evaluate seven dose levels of ONC-841 given once every 4 weeks.
- Conditions
- Advanced Solid Tumor
- Being tested
- ONC-841
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONC-841Drug
Also called Anti-SIGLEC10 antibody
ONC-841 (anti-SIGLEC10) is a humanized antibody that binds to human sialic acid-binding Ig-like lectin 10 and has a human immunoglobulin G4 (IgG4) Fc domain.
| Study group | Role | What they receive |
|---|---|---|
| ONC-841 | Experimental | ONC-841 will be given by IV infusion in designated dose, q4w. Receives: Drug: ONC-841 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
The number of subjects who have Dose limiting toxicity (DLT) as defined by protocol DLT criteria during the first cycle of study drug, ONC-841, administration.
Measured: 28 Days
Maximum Toxicity Dose (MTD)
Maximal tolerable dose (MTD), the study drug, ONC-841, dose level that has two out of six subjects who have DLT.
Measured: 28 Days
Secondary outcomes (2)
Cmax of ONC-841
The highest Serum concentration of ONC-841 after IV infusion at cycle 1 and cycle 3 from different timepoints (within 60 minutes before dosing, 60 minutes post-dose, 6 hours post-dose, 24 hours post dose, day 8, 15 and 21 post-dose) after drug administration.
Measured: 84 days
The serum half-life of ONC-841
To determine the drug concentration in serum samples that are taken in various timepoints (Cycle 1 and Cycle 3: within 60 minutes before dosing, 60 minutes post-dose, 6 hours post-dose, 24 hours post dose, day 8, 15 and 21 post-dose. Cycle 2 and Cycle 4-13: within 60 minutes before dosing and 60 minutes post-dose) during the treatment in order to calculate drug half life.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start23 Aug 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (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
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoC4, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tianhong Li, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352359
- Sponsor's protocol ID
- ONC-841-002
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06352359
- Acronym / sponsor ID
- ONC-841-002
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- OncoC4, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Apr 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.
This is a Phase I/II open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.
Detailed description
ONC-841 is an investigational drug being developed as an anti-tumor treatment. ONC-841 is an antibody drug that binds to immune cells inside the tumor mass. The target molecule is Siglec10, mostly expressed on neutrophils, macrophages and lymphocytes. ONC-841 binds to Siglec10 to block the "do not eat me" signals that cancer cells give to immune system, which allow macrophages and neutrophils to "eat" the tumor cells. The study will use ONC-841 alone for cancer treatment. The study will evaluate seven dose levels of ONC-841 given once every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONC-841 | Experimental | Drug: ONC-841ONC-841 will be given by IV infusion in designated dose, q4w. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must have ECOG score ≤ 1. The body weight should be ≥40 kg.
- A histological or cytological diagnosis of solid tumors and metastatic disease or locally advanced disease.
- Must have measurable target lesion according to RECIST V1.1.
- Adequate organ function as determined by laboratory tests.
- Voluntary agreement to participate as evidenced by written informed consent.
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 chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment.
- The washout period for cancer therapeutic drugs should be 5 half-life or 21 days for chemotherapy, whichever is shorter; 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. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion 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 who have active brain metastases or leptomeningeal metastases. Patients are eligible if brain metastases are adequately treated, 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 they are radiologically stable (i.e. no evidence of progression for ≥4 weeks by repeat imaging performed during study screening), 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-841Also: Anti-SIGLEC10 antibodyONC-841 (anti-SIGLEC10) is a humanized antibody that binds to human sialic acid-binding Ig-like lectin 10 and has a human immunoglobulin G4 (IgG4) Fc domain. | Drug | ONC-841 |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: 28 Days
The number of subjects who have Dose limiting toxicity (DLT) as defined by protocol DLT criteria during the first cycle of study drug, ONC-841, administration.
Maximum Toxicity Dose (MTD)
Time frame: 28 Days
Maximal tolerable dose (MTD), the study drug, ONC-841, dose level that has two out of six subjects who have DLT.
2 secondary outcomes
Cmax of ONC-841
Time frame: 84 days
The serum half-life of ONC-841
Time frame: 84 days
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 25 Jun 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.
Imaan Khan, MD contact
Tianhong Li, MD, PhD principal investigator
University of California, Davis
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 ONC-841 in people with Advanced Solid Tumor, run by OncoC4, Inc. 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 8 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 25 Jun 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 Pan Zheng, MD, PhD ((240) 552-5193, pzheng@oncoc4.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: 28 Days). 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 25 Jun 2026.