Evaluate the Safety and Clinical Activity of HH2853
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaihe Biopharma Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Provided signed written informed consent prior to initiation of any study-related procedures;
Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age);
Histologically or cytologically documented advanced recurrent or metastatic solid tumor.
Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been treated with radiotherapy or other local treatment are generally considered unmeasurable unless there is definite progression of the lesion.)
Disqualifiers
Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five half-lives; Local radiotherapy within 14 days of first dose.
Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
Patients with prior transplant are excluded;
Major surgery within 4 weeks prior to first dose;
Trial design
Treatments tested in this trial
- HH2853 Tablets
Treatment groups
254 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov