NCT06827613招募中1 期
A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)
研究概览
简要总结
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.
- •Tumor Type:
- •mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC
- •HR+/HER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+/HER2- breast cancer
- •Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:
- •No concurrent treatment for CNS disease (eg, surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent); No concurrent leptomeningeal disease or cord compression.
排除标准
- •History of known autoimmune disease with exceptions of:
- •Psoriasis
- •Atopic dermatitis or other autoimmune skin condition not requiring systemic treatment
- •History of Graves' disease, now euthyroid for > 4 weeks
- •Hypothyroidism managed by thyroid replacement
- •Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs
- •Adrenal insufficiency well-controlled on replacement therapy
- •Major surgery or traumatic injury within 8 weeks before first dose of study intervention
- •Unhealed wounds from surgery or injury
- •Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
- •Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention.
- •Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed.
- •Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
- •Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.
- •Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)
- •Treatment with >10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study intervention. Exceptions may be made for participants who have had allergic reactions to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed
研究组 & 干预措施
Phase 1 Safety Run-In: Advanced Solid Tumors
Experimental
Interventions: STAR0602 + Sacituzumab Govitecan
干预措施: STAR0602 (Drug)
Phase 1 Safety Run-In: Advanced Solid Tumors
Experimental
Interventions: STAR0602 + Sacituzumab Govitecan
干预措施: Sacituzumab Govitecan (SG) (Drug)
Phase 2 Cohort Expansion: Advanced Solid Tumors
Experimental
Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1
干预措施: STAR0602 (Drug)
Phase 2 Cohort Expansion: Advanced Solid Tumors
Experimental
Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1
干预措施: Sacituzumab Govitecan (SG) (Drug)
结局指标
主要结局
Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)
时间窗: 21 days following the first dose of STAR0602 + Sacituzumab Govitecan
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events
时间窗: Up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR)
时间窗: Up to 3 years
Proportion of participants who have a complete response (CR) or partial response (PR)
次要结局
- Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of Participants with Disease Contral (DCR)(Up to 3 years)
- Phase 1 and 2 (Safety Run-In and Cohort Expansion): Duration of Response (DOR)(Up to 3 years)
- Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Total Body Clearance (CL) for STAR0602(Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years)
- Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Volume of Distribution (Vd) for STAR0602(Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years)
- Phase 1 and 2 (Safety Run-In and Cohort Expansion): Progression Free Survival (PFS)(Up to 3 years)
- Phase 1 and 2 (Safety Run-In and Cohort Expansion): Overall Survival (OS)(Up to 3 years)
- Phase 1 and 2 (Safety Run-In and Cohort Expansion): Maximum Observed Concentration (Cmax) for STAR0602(Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years)
- Phase 1 and 2 (Safety Run-In and Cohort Expansion): Area Under the Concentration Curve (AUC) for STAR0602(Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years)
研究者
研究点 (8)
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相关资讯
Marengo Therapeutics Reports Confirmed Complete Responses in Phase 2 Trial of Invikafusp Alfa Plus TRODELVY for Metastatic Breast Cancer- Marengo Therapeutics announced late-breaking Phase 2a results from the STARt-002 trial showing confirmed complete responses with invikafusp alfa plus TRODELVY in heavily pretreated metastatic breast cancer patients.
- The combination demonstrated encouraging clinical activity across both triple-negative breast cancer (TNBC) and HR+/HER2- breast cancer subtypes, including patients who had not responded to any prior therapy.
- The safety profile remained consistent with the known profiles of individual agents, while pharmacodynamic analyses confirmed invikafusp alfa maintained its mechanism of action in the combination regimen.
- Marengo also unveiled its second STAR platform candidate, IPN01203/STAR0501, being developed in partnership with Ipsen for solid tumors.5 months agoMarengo Therapeutics Advances Phase 2 Expansion of Invikafusp Alfa-Trodelvy Combination for Metastatic Breast Cancer- Marengo Therapeutics has completed the Phase 1b safety run-in of its STARt-002 trial and determined the recommended Phase 2 dose for invikafusp alfa combined with Trodelvy in metastatic breast cancer patients.
- The study is advancing into two expansion cohorts targeting hormone receptor-positive, HER2-negative and triple-negative metastatic breast cancer, with early signs of anti-tumor activity including confirmed partial responses.
- This first-in-class T-cell agonist combination represents a novel approach to enhance immunotherapy efficacy in immunologically "cold" tumors like breast cancer.
- The trial is enrolling patients across leading North American cancer centers, positioning Marengo strategically in the competitive TROP2-targeted therapy market projected to exceed $4 billion by 2030.last year