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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors
Phase 1 & 2
Waitlist Available
Research Sponsored by Haihe Biopharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up c1d1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h;c1d2, pre-dose and 24h; c1d7,c1d10, pre-dose.c1d15 at pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h, c1d16 pre-dose and 24h,c1d22 pre-dose,and c2d1,c3d1,c5d1,c7d1,c9d1 pre-dose.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests HH2710, a new drug for patients with advanced tumors. It works by blocking proteins that help cancer cells grow, potentially slowing or stopping the cancer.
Eligible Conditions
- Advanced Tumors
- Erdheim-Chester Disease
- Skin Cancer
- Melanoma
- Non-Small Cell Lung Cancer
- RAS/RAF/MEK/ERK Mutated Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ c1d1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h;c1d2, pre-dose and 24h; c1d7,c1d10, pre-dose.c1d15 at pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h, c1d16 pre-dose and 24h,c1d22 pre-dose,and c2d1,c3d1,c5d1,c7d1,c9d1 pre-dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~c1d1,pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h;c1d2, pre-dose and 24h; c1d7,c1d10, pre-dose.c1d15 at pre-dose,15min,30min,1h,2h,3h,4h,6h,8h,12h, c1d16 pre-dose and 24h,c1d22 pre-dose,and c2d1,c3d1,c5d1,c7d1,c9d1 pre-dose.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MTD (Maximum Tolerated Dose)
Number of Participants Who Experienced DLT (Dose Limiting Toxicities)
Heart rate
Secondary study objectives
Pharmacokinetic Measures - Apparent Clearance (CL/F)
Pharmacokinetic Measures - Apparent Volume of Distribution (Vz/F)
Pharmacokinetic Measures - Peak Plasma Concentration (Cmax)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose escalation study of HH2710Experimental Treatment1 Intervention
to determine the MTD of HH2710 and/or Recommended Phase II dose (RP2D).
Find a Location
Who is running the clinical trial?
Haihe Biopharma Co., Ltd.Lead Sponsor
16 Previous Clinical Trials
1,890 Total Patients Enrolled