2025-524620-22-00招募中2 期
A 2-part phase 1/2 open-label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 in combination with anti-cancer therapy in participants with advanced solid tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 15
- 主要终点
- Part 1: Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and clinical laboratory abnormalities (incl. electrocardiogram [ECG]).
研究概览
简要总结
Part 1: Primary To evaluate the safety and tolerability of ODM-212 in combination with anti-cancer therapy thereby determining the recommended part 2 dose in participants with selected advanced solid tumours. Part 2: Primary To evaluate the safety and tolerability of ODM-212 in combination with anti-cancer therapy in participants with selected advanced solid tumours.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent (IC; or witness consent) prior to any trial-specific screening procedures.
- •Amenable for paired fresh tumour biopsy at screening period and on-treatment. Exemptions possible by the sponsor’s decision.
- •Willing and able to comply with all aspects of the protocol.
- •Male or female participants ≥18 years old.
- •Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •Life expectancy of >12 weeks, in the opinion of the investigator.
- •Ability to take oral medications and willing to record daily adherence to investigational product.
- •Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumours and who are able and willing to receive one of the anti-cancer therapies studied in this trial according to the investigator
- •Part 2 only: Participants must have measurable disease by response evaluation criteria in solid tumours (RECIST) v. 1.1
- •A recent (taken up to 1 year ago), representative tumour tissue sample (from primary tumour or from metastasis) must be available. Tissue must be a core needle biopsy, excisional or incisional biopsy. Biopsies of bone lesions that do not have a soft tissue component or decalcified bone tumour samples are also not acceptable. Exemptions possible by the sponsor’s decision
排除标准
- •Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the participants have completed curative therapy.
- •Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g. nausea, diarrhoea, or vomiting) that might impair the bioavailability of ODM-212
- •Use of other investigational medicinal products within 2 weeks or at least 5 half-lives (whichever is longer) before trial treatment administration, or any persistent unresolved toxicity from such treatment that, according to the judgement of the investigator, may pose a health risk for the participant, if taking part in the trial. For drugs such as investigational monoclonal antibodies with half-lives >10 days, at least 8 weeks is required. In addition, all visits (apart from survival follow-up) related to the use of another investigational medicinal product must be completed before dosing with trial treatments may commence.
- •Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, shingles, oral polio, Bacillus Calmette–Guérin [BCG], yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dose of study drug.
- •Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 ms, a prolonged QTc interval (QTcF/B >470 ms) as demonstrated by 2 out of 3 repeated ECG at screening, performed according to local practice. A history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT Syndrome) or the use of drugs that prolong the QT interval and are clearly associated with a known risk of torsade de pointes, even when taken as recommended per Crediblemeds.org QTdrugs list.
- •Significant cardiovascular impairment: history of congestive heart failure of New York Heart Association (NYHA) Class III-IV, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke, left ventricular ejection fraction (LVEF) <50%, cardiac arrhythmia requiring medical treatment (including oral anticoagulation) within 6 months prior to the first dose of trial treatment.
- •Female participants who are breastfeeding or pregnant at screening or baseline. A separate baseline assessment for pregnancy is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- •Female participants of childbearing potential who meet any of the following criteria: - Had unprotected sexual intercourse within 30 days before study entry or who do not agree to use a highly effective method of contraception throughout the entire treatment period and for time periods specified in the protocol after treatment discontinuation. Highly effective contraception methods are specified in the protocol. - Are neither using a highly effective method of contraception as listed in the protocol nor currently abstinent or do not agree to refrain from sexual activity during the treatment period and for the time periods listed in the protocol after treatment discontinuation. - Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive combined with a barrier method (preferably male condom) during the trial and for the time periods listed in the protocol after treatment discontinuation. - NOTE: All female participants will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilised surgically (i.e. total hysterectomy or bilateral oophorectomy, with surgery at least 1 month before dosing).
- •Male participants who are unwilling to practice acceptable methods of birth control during treatment and for periods specified in the protocol after treatment discontinuation, with partners who are women of childbearing potential (WOCBP); in addition no sperm donation is allowed during the treatment periods and periods specified in the protocol following treatment discontinuation. Acceptable methods of birth control for men are specified in the protocol; in addition, partners who are WOCBP must use at least one form of highly effective contraception as listed in exclusion criteria 16 in the protocol.
- •At least moderately impaired kidney function (estimated glomerular filtration rate [eGFR] <60 ml/min), calculated as follows: eGFR(ml/min) = eGFR (ml/min/1.73m2) x [BSA(m2):1.73] where the body surface area (BSA) is calculated using e.g. the Mosteller formula: BSA=√[(Height (cm)× Weight(kg)) / 3600]
- •Hepatic impairment defined as having any of the following laboratory values at screening: total bilirubin ≥1.5xupper limit of normal (ULN) (or >3xULN for participants with Gilbert’s syndrome), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3xULN (or >5xULN for participants with liver metastasis), or albumin ≤25 g/l.
- •Prior anti-cancer therapy within less than 2 weeks before trial treatment administration.
- •Abnormalities in coagulation values defined as international normalised ratio (INR) >1.5xULN at screening (unless participant is receiving anticoagulant therapy, as long as participant’s laboratory values are within therapeutic range of intended use of anticoagulants).
- •Haemoglobin <9 g/dl (in absence of blood transfusion within 7 days of value obtained), absolute neutrophil count <1500/µl (1.5 x 109/l), platelet count <100 000/µl (100 x 109/l).
- •Any other major illness, any history of a medical condition or a concomitant medical condition that, in the investigator’s judgment, will substantially increase the risk associated with, or compromise the participant’s participation in this trial.
- •Participant has known sensitivity to any of the products to be administered during dosing
- •Any contraindication to a treatment with the applicable combination partners as mentioned in the prescribing label. Potential contraindications include but are not limited to: active or severe auto-immune disease, history of colitis, hepatitis, pneumonitis; interstitial lung disease or severe pulmonary fibrosis.
- •History of treatment with other TEAD inhibitors.
- •Any persistent unresolved toxicity from previous anti-cancer therapies of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Ongoing adjuvant treatments for previous cancers are allowed as concomitant treatments if they do not have direct anti-tumour effect on the index tumour (e.g. hormone-suppressing agents).
- •Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before trial treatment administration. Radiopharmaceuticals should be expected to have cleared sufficiently from the participant’s body before trial treatment administration.
- •Participants with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and have been adequately treated with local therapy.
- •Any severe active infection within 1 week of trial enrolment.
- •Known positive tests for hepatitis B surface antigen or hepatitis C virus (HCV) RNA; known human immunodeficiency virus (HIV) infection. Screening test is not required unless participant has clinical findings suggestive of HIV, hepatitis B virus (HBV) or HCV infection.
- •Major surgery within 4 weeks before the first dose of trial treatment or minor surgery within 1 week (participant must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2).
- •Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses >10 mg/day prednisone or equivalent) within 2 days before trial treatment administration.
研究组 & 干预措施
IPILIMUMAB
Test
干预措施: IPILIMUMAB (Drug)
PACLITAXEL ALBUMIN-BOUND
Test
干预措施: PACLITAXEL ALBUMIN-BOUND (Drug)
NIVOLUMAB
Test
干预措施: NIVOLUMAB (Drug)
SOTORASIB
Test
干预措施: SOTORASIB (Drug)
GEMCITABINE
Test
干预措施: GEMCITABINE (Drug)
结局指标
主要结局
Part 1: Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and clinical laboratory abnormalities (incl. electrocardiogram [ECG]).
Part 1: Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and clinical laboratory abnormalities (incl. electrocardiogram [ECG]).
Part 2: Incidence of TEAEs, SAEs and clinical laboratory abnormalities (incl. ECG).
Part 2: Incidence of TEAEs, SAEs and clinical laboratory abnormalities (incl. ECG).
次要结局
- Part 1: Efficacy evaluations: objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and duration of stable disease will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Part 1: ODM-212 concentrations and pharmacokinetic (PK) variables (including but not limited to Cmax, AUCt, AUC0-24) on the last day of cycle 1 or 2
- Part 2: ORR, per RECIST 1.1, DOR, DCR, clinical benefit rate (CBR), PFS and overall survival (OS).
- Part 2: Dose selection based on safety, exposure, and all other available nonclinical, clinical, PK and biomarker data.
- Part 2: ODM-212 concentrations and PK variables (including but not limited to Cmax, AUCt, AUC0-24) on the last day of cycle 1.
研究者
Clinical Study Director
Scientific
Orion Corporation
研究点 (15)
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