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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
HH2853 Tablets
DrugProposed daily dose (BID): 50mg, 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the MTD in order to better understand safety, PK or PD.
Treatment groups
254 Participants
are divided into 1 treatment groupGroup A: HH2853 administered on a BID schedule in continuous 28-day treatment cyclesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerated Dose (MTD)
Determine MTD of HH2853
Time frame
28-day treatment cycles2
Recommended phase II dose (RP2D)
Determine RP2D of HH2853
Time frame
28-day treatment cycles3
Adverse events assessed according to NCI-CTCAE V5.0
Evaluate the safety of HH2853
Time frame
28-day treatment cycles4
Dose limiting toxicities (DLT)
Evaluate the tolerability of HH2853
Time frame
28-day treatment cyclesSecondary outcomes
1
AUClast
Characterize the pharmacokinetic profile of HH2853
Time frame
28-day treatment cycles2
AUCinf
Characterize the pharmacokinetic profile of HH2853
Time frame
28-day treatment cycles3
Cmax
Characterize the pharmacokinetic profile of HH2853
Time frame
28-day treatment cycles4
Tmax
Characterize the pharmacokinetic profile of HH2853
Time frame
28-day treatment cyclesOther outcomes
1
Overall survival (ORR）
Assess the preliminary efficacy of HH2853
Time frame
28-day treatment cycles2
Change in tri-methylation of Histone H3K27 (H3K27me3)
Assss the pharmacodynamic response
Time frame
14-day treatment3
Biomarker Status
Explore the relationship between the alteration status of biomarker and treatment efficacy
Time frame
28-day treatment cycles4
Overall survival (OS)
Assess the preliminary efficacy of HH2853
Time frame
28-day treatment cyclesSponsors and contacts
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Source ClinicalTrials.gov