Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Pharmaceutical Co., Ltd.
About this trial
Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Available RET-gene abnormalities determined on tissue biopsy or liquid biopsy. If deemed appropriate by the investigator, determination on a pleural cell block or cell pellet is also acceptable.
Adequate hematopoietic, hepatic and renal function
Advanced solid tumors
Disqualifiers
Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug
Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment.
Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator.
Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion.
Trial design
Design model
Sequential
Treatments tested in this trial
TAS0953/HM06
DrugPhase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
TAS0953/HM06
DrugPhase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days
Treatment groups
244 Participants
are divided into 2 treatment groupsGroup A: TAS0953/HM06 Phase 1Experimental treatment 1 intervention
Group B: TAS0953/HM06 Phase 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Incidence rate and category of dose limiting toxicities (DLTs)
Time frame
At the end of Cycle 1 (each cycle is 21 days)2
Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)
Time frame
At the end of Cycle 1 (each cycle is 21 days), and at the end of every subsequent cycle (each cycle is 21 days) for approximately 10 months (or earlier if patient discontinues the study)3
Phase 2: Objective Response Rate (ORR) by independent central review
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by independent central review
Time frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease.Secondary outcomes
1
Phase 1 (dose expansion): Objective Response Rate (ORR) by independent central review
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by independent central review
Time frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease2
Phase 2: ORR by Investigator
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by Investigator
Time frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease3
Phase 2: Disease Control Rate (DCR)
Proportion of patients with confirmed complete response (CR), partial response (PR) and Stable Disease according to RECIST 1.1 as assessed by Investigator
Time frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease4
Phase 2: Time to Tumor Response (TTR)
Time from first dose to first documentation of objective tumor response (CR or PR)
Time frame
From date of randomization until the date of first documentation of objective tumor response, assessed up to an average of 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov