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

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haihe Biopharma Co., Ltd.; ShangHai HaiHe Pharmaceutical

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