Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors

Part of paid clinical trials in New York, New York.

Sponsor
OncoC4, Inc.
Study ID
NCT07408258
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONC-783 — DRUG
    ONC-783 is a bispecific humanized monoclonal antibody targeting CD24 and CD3.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ONC-783
    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.

Primary Outcome Measure

Recommended Phase 2 dose (RP2D) [ Time Frame: 24 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Aiwu Ruth He, MD, PhD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NYMD Anderson Cancer Center· Houston, TX

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