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.
Recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| HH2710 | Dose escalaltion study of HH2710 |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Dose escalaltion study of HH2710 | Experimental | to determin the MTD of HH2710 and/or Recommended Phase II dose (RP2D). |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | MTD(Max tolerance does) |
| Time Frame: | 21 Days |
| Safety Issue: | |
| Description: | To evaluate the MTD in patients with advanced solid tumor |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Haihe Biopharma Co., Ltd. |
February 8, 2021
