A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946

Part of paid clinical trials in Fairfax, Virginia.

Sponsor
Yuhan Corporation
Study ID
NCT06616766
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • NSCLC (Non-small Cell Lung Cancer)
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • YH42946 — DRUG
    YH42946

Study Details

The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.

Key Dates

Start date
Oct 2, 2024
Status verified
Nov 2025
Primary completion
Mar 15, 2028
Completion
Jul 29, 2028

Study Design

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

Arms

  • Experimental: Part 1 and Part 2
    Part 1: Dose escalation arm to determine the MTD Part 2: Dose expansion part to select RD. Several independent cohorts are planned.

Primary Outcome Measure

Treatment Emergent Adverse Events(TEAE)s [ Time Frame: Through study completion, during the first 21 days of DLT evaluation period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Next Oncology VirginiaFairfaxVirginia22031
Alexander I. Spira

Find similar trials in Fairfax, VA

By research site
Next Oncology Virginia· Fairfax, VA

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