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Advanced Solid TumorPhase 1NCT06219499

Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841

A Phase 1 study testing ONC-841 in people with Advanced Solid Tumor, run by OncoC4, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose, multi-cohort study. The study will evaluate 5 dose levels of the investigational product, in 5 cohorts of 8 healthy volunteers per cohort. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ONC-841
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2024to Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  • Adult males and females, 18 to 55 years of age (inclusive) at screening.
  • Body mass index ≥ 18.0 and ≤ 30.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50 kg at screening.
  • Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration and have a negative test for cotinine at the screening visit and at check- in on Day -1.
  • Medically healthy without clinically significant abnormalities (in the opinion of the PI) at the screening visit and prior to dosing at the timepoints indicated in the Schedules of Assessments (SoA), including:
  • Physical examination without any clinically significant findings;
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  • Systolic blood pressure in the range of 90 to 140 mmHg (inclusive) and diastolic blood pressure in the range of 40 to 90 mmHg (inclusive) after 5 minutes in supine (or semi- supine) position;
  • Heart rate in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in supine (or semi- supine) position;
  • Body temperature (tympanic or oral) in the range 35.5°C to 37.5°C (inclusive);
  • No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests (any of the routine laboratory test may be repeated at the discretion of the PI);
  • Triplicate 12-lead ECG (taken after the volunteer has been supine (or semi-supine) for at least 5 minutes) with a QT interval corrected using the Fridericia method (QTcF) ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities.
  • Female volunteers must:
  • Be of nonchildbearing potential i.e., be surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or be postmenopausal, where menopause is defined as 12 months of amenorrhea in the absence of other biological causes. Females under the age of 55 years must have a documented serum follicle-stimulating hormone (FSH) level > 40mIU/mL to confirm menopause (females who are taking Hormone Replacement Therapy (HRT) should provide evidence that they are post-menopausal or should be excluded as their post-menopausal status cannot be confirmed by measuring FSH - alternatively they would need to stop HRT to allow FSH to be measured).
  • If of childbearing potential (defined as any female who has experienced menarche and who has not undergone surgical sterilisation and is not postmenopausal), the participant:
  • Must have a negative serum test at the screening visit and a negative urine pregnancy test within 24 hours prior to the start of study drug;
  • Must not be breastfeeding, lactating or planning pregnancy during the study period;
  • Must agree not to attempt to become pregnant;
  • If not exclusively in same-sex relationships, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner; refer to Appendix 5. Highly Effective Forms of Contraception) after signing consent, during the study, and at least 30 days after the EoS visit;
  • Must agree to not donate ova for at least 30 days after the EoS visit.
  • Male participants, if not surgically sterilised, must agree to:
  • Not donate sperm after signing consent, during the study, and at least 90 days after the EoS visit;

Who cannot join

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant (participants with resolved childhood asthma may be included in the study).
  • Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
  • Suffer from frequent or recurrent infections (defined as ≥3 occurrences in the 12 months preceding first study drug administration or 2 occurrences in the 6 months preceding first study drug administration).
  • Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
  • Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
  • Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration (prior use of nasal sprays for hayfever may be permitted if used > 30 days prior to study drug administration or alternatively at the discretion of the PI).
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  • History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
  • Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the PI, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
  • Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or Quantiferon Gold® (Tuberculosis (TB) infection) at the screening visit.
  • Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs (prior gall bladder and/or appendix removal is not exclusionary if the procedure was undertaken ≥ 3 months prior to study drug administration; if less than 3 months, history of such procedures may still be considered not exclusionary if it is deemed appropriate by the PI).
  • Estimated creatinine clearance (CrCl) < 60 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
  • History of substance abuse or alcohol abuse within 12 weeks prior to the screening visit (defined as more than an average of 14 standard drinks per week or regular consumption of more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]).
  • 13. Positive drugs of abuse or alcohol breath test results at the screening visit or at check-in (Day -1).
  • 14. Use of any prescription or over-the-counter medication (including herbal products, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration - exceptions include occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days), ibuprofen (doses of 400 mg up to every 6 hours or 1.2 g per day maximum for no more than 3 consecutive days), topical ointments, and vitamins or dietary supplements.
  • 15. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the PI, would interfere with the volunteer's ability to participate in the trial.
  • 16. Known hypersensitivity to any of the study drug ingredients. 17. Use of any vaccinations within 14 days (within 4 weeks for live virus vaccines) prior to the first study drug administration.
  • 18. For women of childbearing potential, a positive serum pregnancy test at the screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) at check-in (Day -1).
  • 19. Females who are breastfeeding or planning to breast feed at any time during the study.
  • 20. Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration.
  • 21. Treatment with an investigational drug in another clinical trial within 60 days or 5 half-lives of the other investigational drug (whichever is longer) prior to the first administration of study drug in this trial.
  • 22. Any other condition or prior therapy that in the opinion of the PI would make the volunteer

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841 When Administered Intravenously in Healthy Adult Subjects

The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose, multi-cohort study. The study will evaluate 5 dose levels of the investigational product, in 5 cohorts of 8 healthy volunteers per cohort. In each cohort, 6 volunteers will receive the investigational product and 2 volunteers will receive placebo.

Being tested
ONC-841, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONC-841Drug

    ONC-841 is a humanized monoclonal antibody.

  • PlaceboOther

    Placebo

Study groups in NCT06219499
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
ONC-841ExperimentalNot described
Receives: Drug: ONC-841

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: 42 Days

  2. 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: 42 Days

Secondary outcomes (2)

  1. Cmax of ONC-841

    The highest Serum concentration of ONC-841 after IV infusion at cycle 1 and cycle 3 dosings from different timepoints after drug administration.intravenous dose in healthy adult volunteers

    Measured: PK samplings in cycle1, pre-dose and post-dose samples, and End of Treatment

  2. The serum half-life of ONC-841

    To determine the drug concentration in serum samples that are taken in various timepoints during the treatment in order to calculate drug half life.

    Measured: PK samplings in cycle1, pre-dose and post-dose samples, and End of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Why it stopped: FDA reviewers asked for Phase 1 study in Oncology subjects, not in healthy volunteers.

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06219499
Sponsor's protocol ID
ONC-841-001
Status last verified
Apr 2024
First submitted
29 Dec 2023
Last updated
3 Apr 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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..

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 21 inclusion and 21 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: withdrawn, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: 42 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?

On the ClinicalTrials.gov record for NCT06219499.

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 3 Apr 2024.

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