A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors

Sponsor
Huahui Health
Study ID
NCT07623369
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HH160 — DRUG
    Administered by intravenous infusion every 3 weeks (Q3W)

Study Details

This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a Part 1 : Dose Escalation
    Participants with advanced solid tumors will receive escalating doses of HH160
  • Experimental: Phase 1a Part 2: Safety Expansion
    Participants with selected advanced solid tumors, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal carcinoma (CRC), and other tumor types, will receive HH160 at dose levels determined to be tolerable during dose escalation to further evaluate safety and tolerability.

Primary Outcome Measure

Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of study drug to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months ]

Central Contacts

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