NCT06457997终止1 期
First-in-Human, Phase 1b Study of PHN-010, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors
Pheon Therapeutics10 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
研究概览
简要总结
This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has histologically confirmed, advanced/metastatic:
- •Colorectal adenocarcinoma (CRC), or
- •Serous, endometroid, or clear-cell epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, or
- •Serous, endometroid or clear-cell endometrial cancer, or
- •Adenocarcinoma or squamous-cell carcinoma of the cervix, or
- •Non-small cell lung cancer (NSCLC).
- •Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.
- •Has measurable disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Has adequate organ function.
- •Has available tumor tissue sample at screening (either an archival specimen collected ≤ 3 years prior to the date of informed consent or fresh biopsy material).
排除标准
- •Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.
- •Has unstable central nervous system metastasis.
- •Has persistent toxicities from previous systemic anti-cancer treatments of Grade >
- •Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.
- •Has received wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
- •Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
- •Has acute and/or clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
- •Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.
- •Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Phase 1a and Phase 1b
Experimental
PHN-010 is administered intravenously.
干预措施: PHN-010 (Drug)
结局指标
主要结局
Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
时间窗: 18 months
Overall response rate (ORR) (Phase 1b)
时间窗: 36 months
Incidence of dose limiting toxicities (Phase 1a)
时间窗: 18 months
Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)
时间窗: 18 months
次要结局
- Disease control rate (DCR) (Phase 1a and 1b)(36 months)
- Progression free survival (PFS) (Phase 1a and 1b)(36 months)
- Time to response (TTR) (Phase 1a and 1b)(36 months)
- Overall survival (OS) (Phase 1a and 1b)(36 months)
- Cancer antigen 125 (CA-125) response (Phase 1a and 1b)(36 months)
- Time to CA-125 response (Phase 1a and 1b)(36 months)
- Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)(36 months)
- Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)(36 months)
- Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)(36 months)
- Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)(36 months)
- Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)(36 months)
- Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)(36 months)
- Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)(36 months)
- Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)(36 months)
- Best overall response (BOR) (Phase 1a and 1b)(36 months)
- Concentration of anti-drug antibodies (Phase 1a and 1b)(36 months)
- Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)(36 months)
- Type, incidence and severity of AEs and SAEs (Phase 1b)(18 months)
- Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)(36 months)
- Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)(36 months)
- Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)(36 months)
研究者
研究点 (10)
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