Study of BEBT-607 Tablets in The Treatment of Advanced or Metastatic Solid Tumors With KRAS G12C … (NCT06117371) | Clinical Trial Compass
UnknownPhase 1
Study of BEBT-607 Tablets in The Treatment of Advanced or Metastatic Solid Tumors With KRAS G12C Mutation
China126 participantsStarted 2023-09-04
Plain-language summary
This is a two-phase, multicenter, open phase I clinical study, with phase Ia as dose escalation phase and phase Ib as dose expansion phase, to evaluate the safety tolerability and pharmacokinetic characteristics of BEBT-607 tablets in patients with advanced or metastatic solid tumors associated with KRAS G12C mutation. To evaluate the efficacy of BEBT-607 tablets in the treatment of patients with advanced or metastatic solid tumors with KRAS G12C mutation, and to determine the recommended dose (RP2D) for Phase II clinical trials of BEBT-607 tablets in patients with advanced or metastatic solid tumors with KRAS G12C mutation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: ≥18 years old, gender unlimited.
. Patients with histologically confirmed locally advanced or metastatic solid tumors who have failed standard therapy, are intolerant to standard therapy, or have no standard therapy.
. Patients with stage I b are required to have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1). Tumor lesions that have previously received radiotherapy or other local treatment are considered measurable lesions only if disease progression at the treatment site is clearly documented after completion of treatment.
. The ECOG score is 0-1, and there is no decline in physical agility in the two weeks before the first medication.
. Expected survival is at least 12 weeks.
. For patients with KRAS G12C mutation, previously confirmed genomic KRAS GI2C mutation results in tumor tissue specimens and hematological specimens were acceptable.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MTD
Timeframe: Phase Ⅰa:Day 2 after the single dose phase, day 1, day 15, and day 28 of the first cycle of the continuous dose phase，assessed up to 4 weeks.
2
DLT
Timeframe: Phase Ⅰa:Day 2 after the single dose phase, day 1, day 15, and day 28 of the first cycle of the continuous dose phase，assessed up to 4 weeks.
3
RDE
Timeframe: Phase Ⅰa:Day 2 after the single dose phase, day 1, day 15, and day 28 of the first cycle of the continuous dose phase，assessed up to 4 weeks.
4
AE
Timeframe: Phase Ⅰa:From the first administration of the study drug to 28 days after the last administration of the study drug.
5
ORR
Timeframe: Phase Ⅰb:Every 8 weeks，assessed up to 20 months.
6
PR2D
Timeframe: Phase Ⅰb:Every 8 weeks，assessed up to 20 months.
. Good organ and bone marrow function, provided no blood transfusion has been received within 14 days prior to the screening period, and these results should be completed within 7 days prior to initiation of study therapy:
. Bone marrow function should be satisfied: Absolute Neutrophil Count (ANC)≥1.5×10\^9/L; Platelet count (PLT)≥100×10\^9/L: hemoglobin (Hb)≥9g/dL.
Exclusion criteria
. Advanced patients with a short-term risk of life-threatening complications (patients with visceral crisis).
. Symptomatic or unstable central nervous system(CNS) metastasis, characterized by clinically symptomatic cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease, and/or progressive growth. Stable is defined as: 1) seizure-free status continued for \>12 weeks with or without antiepileptic drugs; 2) glucocorticoids is not required; 3) Continuously multiple consecutive imaging examinations (scan interval of at least 8 weeks) showed a stable state.
. Known impairment of gastrointestinal (GI) function or Gl diseases that may significantly affect the absorption or metabolism of oral drugs.
. Patients who had major surgery (or planned major surgery during the study period), chemotherapy, radiation therapy, any investigational drug, or other anticancer therapy within 4 weeks prior to study entry.
. Known or suspected allergic symptoms to any component of BEBT-607 tablets.
. The patient received the following treatments in the 7 days prior to study beginning and plans to use the following drugs throughout the regimen: drugs known to be potent inhibitors/inducers of cytochrome P450 3A4(CYP3A4), cytochrome P450 2C8(CYP2C8), and cytochrome P450 2D6(CYP2D6); Drugs known to significantly lengthen the QT interval.
. At rest, QT interval (QTc)\>470msec(female) or \>450msec(male) of Fridericia's mean correction from 3 electrocardiogram (ECG) tests (only retest and take 3 mean corrections if the first ECG indicates QTc\>470msec(female) or \>450msec(male)); A history of long QT syndrome or a proven long QT synthesis Family history: Clinically significant history of ventricular arrhythmias, or current use of antiarrhythmic drugs or implantation of a defibrillation device for the treatment of ventricular arrhythmias.
. Uncontrolled electrolyte disturbances may affect the effect of QTc protractive drugs (e.g., hypocalcaemia \<1.0mmol/L, hypokalemia \< lower limit of normal).