First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors

Genmab A/S31 个研究点分布在 7 个国家目标入组 268 人2024年5月22日

概览

阶段: 1/2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Genmab A/S
入组人数: 268
试验地点: 31
主要终点: Dose Escalation Part: Dose-liming toxicities (DLTs)
状态: 招募中
最后更新: 11个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Dose Escalation Part: • Determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) and recommended phase 2 dose (RP2D), or dose(s) to be studied in the Expansion part • Characterize the safety profile of GEN1047 Dose Expansion Part: • Evaluate antitumor activity based on response assessment criteria (RECIST v1.1) • Determine RP2D (unless determined in the Escalation part)

注册库

euclinicaltrials.eu

开始日期

2024年5月22日

结束日期

待定

最后更新

11个月前

性别

Female

研究者

发起方

Genmab A/S

责任方

Principal Investigator

主要研究者

Clinical Trial Information

Scientific

Genmab A/S

入排标准

入选标准

•Dose Escalation part: Subject must have histologically or cytologically confirmed solid tumor(s) in any of the following selected indications for which there is no further available standard therapy likely to confer clinical benefit (or subject is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with GEN1047 may be beneficial (breast cancer, endometrial cancer, ovarian cancer, squamous non-small-cell lung cancer [NSCLC-SCC]).
•Dose Escalation part: Must have either recurrence after, or progression on or lack of response to available relevant standard of care (SoC) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting.
•Dose Escalation part: Must have at least 1 measurable lesion per RECIST v1.
•The measurable lesion(s) must be outside the field of radiation therapy (RT) if there was prior treatment with RT.
•Dose Escalation part: Must have an Eastern Cooperative Oncology Group performance status (ECOGPS) score of 0 to 1 at Screening and on C1D1 pretreatment.
•Dose Escalation part: Should provide a tumor tissue sample during the Screening period and prior to C1D
•Dose Escalation part: Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy.
•Dose Expansion part – Stage 1: Subjects must have documented PD according to RECIST v1.1 on or after last prior treatment with latest scan performed a maximum of 28 days prior to the first dose.
•Dose Expansion part – Stage 1b and 2: Subject must have advanced (unresectable) or metastatic, histologically confirmed diagnosis of breast cancer
•Dose Expansion part – Stage 1b and 2: Must have documented PD according to RECIST v1.1 on or after last prior treatment with latest scan performed a maximum of 28 days prior to the first dose.

排除标准

•Significant cardiovascular impairment within 6 months of the first dose of trial drug
•Subject with new or progressive brain metastases or spinal cord compression.
•Subject has a history of bowel obstruction related to underlying disease (for Expansion Part Stage 1).
•Subject has been exposed to any prior therapy with a compound targeting CD3 and/or B7H4 or cell based therapies.
•Current pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of non-infectious drug-, immune-, or radiation-related pneumonitis that required steroid.

结局指标

主要结局

Dose Escalation Part: Dose-liming toxicities (DLTs)

Dose Escalation Part: Adverse events (AEs) and safety laboratory parameters

Dose Expansion Part: Objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator

次要结局

Dose Escalation Part: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; and t1/2)
Dose Escalation Part: Anti-drug antibody (ADA) incidence
Dose Escalation Part: Antitumor activity based on Response Evaluation Criteria in Solid Turmors (RECIST v1.1) as assessed by the investigator: Objective response rate (ORR), Duration of response (DOR), Time to response (TTR), Disease control rate (DCR)
Dose Expansion Part: Antitumor activity, based on RECIST v1.1 as assessed by the investigator: DOR, TTR, DCR
Dose Expansion Part: Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator; Overall Survival (OS)
Dose Expansion Part: AEs and safety laboratory parameters
Dose Expansion Part: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; t1/2)
Dose Expansion Part: ADA response