Evaluate the Safety and Clinical Activity of HH2853

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Haihe Biopharma Co., Ltd.
Study ID
NCT04390737
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Epithelioid Sarcoma
  • FL Lymphoma
  • Peripheral T Cell Lymphoma

Eligibility Criteria

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

Interventions

  • HH2853 Tablets — DRUG
    Proposed daily dose (BID): 50mg, 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the MTD in order to better understand safety, PK or PD.

Study Details

This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.

Key Dates

Start date
Sep 8, 2020
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: HH2853 administered on a BID schedule in continuous 28-day treatment cycles
    HH2853 is supplied as tables with dosage strength of 25mg and 200mg. HH2853 Tablet will be administered orally on a continuous twice daily (BID) schedule, on a flat scale of mg and not individually adjusted by weight or body surface area. A treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations. All patients will be treated with HH2853 orally on a continuous BID schedule, beginning on Cycle 1 Day 1. But patients in accelerated titration (ATD) part should be administered a single dose on the first day in order to evaluate the PK of a single dose administration. Dosing is twice daily from the second day thereafter.

Primary Outcome Measure

Maximum tolerated Dose (MTD) [ Time Frame: 28-day treatment cycles ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
Mayo ClinicJacksonvilleFlorida32224-
Mayo ClinicRochesterMinnesota55905-
NEXT OncologySan AntonioTexas78240-

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Mayo Clinic· Phoenix, AZMayo Clinic· Jacksonville, FLMayo Clinic· Rochester, MNNEXT Oncology· San Antonio, TX

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