A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors

A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients With Advanced Tumors

Sponsors

Lead Sponsor: Haihe Biopharma Co., Ltd.

Source Haihe Biopharma Co., Ltd.
Brief Summary

This is a First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients with Advanced Tumors, composed of a Phase I dose escalation and dose expansion stage and a Phase II dose extension stage.

Detailed Description

HH2710 is developed by Shanghai Haihe Pharmaceutical Co., Ltd. HH2710 is a highly potent, selective, reversible, ATP-competitive ERK1/2 inhibitor. This is a first-in-human study of HH2710 and is designed as an open-label, multicenter, Phase I/II study which is composed of a Phase I dose escalation and dose expansion stage and a Phase II dose extension stage.

Overall Status Recruiting
Start Date 2020-01-23
Completion Date 2022-07-31
Primary Completion Date 2021-06-30
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
MTD(Max tolerance does) 21 Days
Enrollment 150
Condition
Intervention

Intervention Type: Drug

Intervention Name: HH2710

Description: 25mg; 50mg; 100mg; 200mg; 300mg; 400mg; 500mgBID (Decided by SMC according to the safety and PK data)

Arm Group Label: Dose escalaltion study of HH2710

Eligibility

Criteria:

Inclusion Criteria: 1. Provide signed and dated informed consent prior to initiation of any study-related procedures. 2. Male or female patients aged ≥ 18 years. 3. Phase I dose escalation stage: Patients who have been diagnosed with histologically or cytological documented, unresectable/metastatic tumors that are refractory or intolerant to standard therapy or for whom no curative standard therapy exists. 4. For LCH/ECD: Eligible patients must have multifocal disease and the diagnosis must be confirmed by pathological evaluation of the affected tissue. 5. Patients in the Phase I dose escalation portion of the trial may have measurable (per RECIST v1.1) or evaluable disease. Patients in the Phase I dose expansion and Phase II portions of the trial must have measurable disease per RECIST v1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status≤1. 7. Predicted life expectancy ≥ 3 months; 8. Willing and able to participate in the trial and comply with all trial requirements; Exclusion Criteria: 1. Gastrointestinal condition which could impair absorption of study medication; 2. Patients who have previously participated in clinical trials of ERK inhibitors drug; 3. Any use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of HH2710

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Harb Wael Abou, M.D.

Phone: 765-446-5111

Email: [email protected]

Location
Facility: Status: Contact:
Horizon Oncology Research, LLC | Lafayette, Indiana, 47905, United States Recruiting Harb Wael Abou, MD [email protected]
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, 48201, United States Recruiting Anthony F. Shields, M.D.,PH.D. 313-576-8735 [email protected]
Shanghai East hospital | Shanghai, China Recruiting Jin Li, M.D. +86-021-38804518 22229 [email protected] Jin Li, M.D. Principal Investigator
Location Countries

China

United States

Verification Date

2021-02-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Dose escalaltion study of HH2710

Type: Experimental

Description: to determin the MTD of HH2710 and/or Recommended Phase II dose (RP2D).

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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