Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors

Официальное название

Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial

Обзор

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.

Подробное описание

This is a multicenter, open-label, Phase Ib clinical trial of HS-20117 combination therapies to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity in participants with advanced solid tumors. The study includes a dose escalation part and a dose expansion part. The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 combination therapies in participants with advanced solid tumor. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 combination therapies in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or EGFR classical mutations, and RAS/BRAF V600E wild type CRC.

Вмешательства

• Препарат HS-20117 combined HS-20093
  HS-20117 + HS-20093
• Препарат HS-20117 combined Platinum-containing chemotherapy
  HS-20117 + cisplatin/carboplatin + pemetrexed
• Препарат HS-20117 combined HS-20093 and 5-FU
  HS-20117 + HS-20093 + 5-FU
• Препарат HS-20117+CAPEOX
  CAPOEX: Oxaliplatin+Capecitabine
• Препарат HS-20117+FOLFIRI
  FOLFIRI=Irinotecan+Leucovorin Calcium+5-FU
• Препарат HS-20117+mFOLFOX6
  mFOLFOX6=Oxaliplatin+Leucovorin Calcium+5-FU

Первичные конечные точки

• Incidence and severity of treatment-emergent adverse events [Срок оценки: rom the date of first dose to 90 days after the final dose.]
• Tolerability of HS-20117 combination therapy: incidence of DLT events, maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20117 in combination therapies. [Срок оценки: From the date of first dose to day 21.]

Вторичные конечные точки (10)

• Efficacy of HS-20117: Objective response rate (ORR) [Срок оценки: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years]
• Efficacy of HS-20117: disease control rate (DCR) [Срок оценки: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years]
• Efficacy of HS-20117: duration of response (DoR) [Срок оценки: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years]
• Efficacy of HS-20117: progression free survival (PFS) [Срок оценки: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years]
• Efficacy of HS-20117: overall survival (OS) [Срок оценки: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years]
• PK parameters: Trough serum concentration (Ctrough) of HS-20117 and HS-20093 [Срок оценки: From the date of first dose to 90 days after the final dose.]
• PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117 [Срок оценки: From the date of first dose to 90 days after the final dose.]
• PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117 [Срок оценки: From the date of first dose to 90 days after the final dose.]
• PK parameters: Maximum serum concentration (Cmax) of HS-20117 and HS-20093. [Срок оценки: From the date of first dose to 90 days after the final dose.]
• Immunogenicity of HS-20117 [Срок оценки: From the date of first dose to 90 days after the final dose.]

Критерии участия

Критерии включения

• Males or females aged 18 - 75 years (inclusive).
• Histologically confirmed unresectable, recurrent or metastatic solid tumors.
• At least one target lesion per the RECIST v1.1.
• ECOG performance status of 0-1.
• Minimum life expectancy \> 12 weeks.
• Males or Females should be using adequate contraceptive measures throughout the study.
• Females must not be pregnant at screening or have evidence of non-childbearing potential.
• Signed Informed Consent Form.

Критерии исключения

• Received or are receiving the following treatments:

• Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
• Monoclonalor bispecific antibodies targeting EGFR.
• Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
• Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117.
• Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117.
• Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
• Major surgery within 4 weeks prior to the first dose of HS-20117.
• Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
• Presence of uncured secondary primary malignancies.
• Untreated, or active central nervous system metastases.
• Severe, uncontrolled or active cardiovascular disorders.
• Serious infection within 4 weeks prior to the first dose of HS-20117.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University Cancer Institute & Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06621563 · HS-20117-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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