Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors

Part of paid clinical trials in Sacramento, California.

Sponsor
OncoC4, Inc.
Study ID
NCT06352359
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • ONC-841 — DRUG
    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 Details

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.

Key Dates

Start date
Aug 23, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ONC-841
    ONC-841 will be given by IV infusion in designated dose, q4w.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: 28 Days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California at Davis Cancer CenterSacramentoCalifornia95817-
UF Health Cancer Center, University of FloridaGainesvilleFlorida32610-
AdventHealth Medical Group Oncology Research at CelebrationKissimmeeFlorida34747-
Norton Cancer CenterLouisvilleKentucky40202-
Rogel Cancer Center, University of MichiganAnn ArborMichigan48109-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
MD Anderson Cancer CenterHoustonTexas770360-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112-

Find similar trials in Sacramento, CA

By research site
University of California at Davis Cancer Center· Sacramento, CAUF Health Cancer Center, University of Florida· Gainesville, FLAdventHealth Medical Group Oncology Research at Celebration· Kissimmee, FLNorton Cancer Center· Louisville, KYRogel Cancer Center, University of Michigan· Ann Arbor, MIThomas Jefferson University Hospital· Philadelphia, PA

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