A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.
2026年6月11日 更新者：Shanghai EpimAb Biotherapeutics Co., Ltd.
A First-in-Human, Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Activity of EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors
The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15.
Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.
調査の概要
詳細な説明
This is a first-in-human (FIH), open-label, Phase I, multicenter dose escalation study to identify the RP2D and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activities of EMB-15 in adult patients with locally advanced/metastatic solid tumors who have progressed on available standard of care or for which no standard therapy exists.This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase.
It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors.
The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose).
研究の種類
介入
入学 (推定)
50
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Xi Yang
- 電話番号：86-21-61951000
- メール：xyang@epimab.com
研究場所
-
-
Guangdong
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Guangzhou、Guangdong、中国、510655
- 募集
- Sixth Affiliated Hospital of Sun Yat-sen University
-
コンタクト：
- Mingfei Zhang
- 電話番号：86-21-61951000
- メール：mfzhang@epimab.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy > 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy.
6) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.
Exclusion Criteria:
Patients meeting any of the following criteria will not be enrolled:
- Any prior ALPP/ALPG targeting therapy
- Has received anticancer therapy, radiotherapy, or investigational drug within < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
- Active autoimmune disease or history of autoimmune disease
- Concurrent malignancy < 5 years prior to study entry
- active infection
- Severe or uncontrolled cardiovascular disease requiring treatment
- Other severe medical conditions
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：EMB-15
This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase.
It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors.
The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose).
|
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
重大な有害事象（SAE）の発生率
時間枠：スクリーニングから経過観察まで（最終投与から30日後）
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SAEの発生率。
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スクリーニングから経過観察まで（最終投与から30日後）
|
|
線量強度
時間枠：スクリーニングから経過観察まで（最終投与から30日後）
|
患者が服用した実際の薬の量を計画量で割ったもの。
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スクリーニングから経過観察まで（最終投与から30日後）
|
|
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.
時間枠：Screening up to follow-up (30 days after the last dose)
|
Incidence and severity of AE.
|
Screening up to follow-up (30 days after the last dose)
|
|
Incidence of dose interruptions
時間枠：Screening up to follow-up (30 days after the last dose)
|
Incidence of dose interruptions of EMB-15 during treatment as a measure of tolerability.
|
Screening up to follow-up (30 days after the last dose)
|
|
The incidence of DLTs during the DLT evaluation period.
時間枠：First infusion to the end of Cycle 1 (each cycle is 28 days)
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The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
|
First infusion to the end of Cycle 1 (each cycle is 28 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Area under the serum concentration-time curve (AUC) of EMB-15
時間枠：Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (AUC).
|
Through treatment until EOT visit, expected average 6 months
|
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Maximum serum concentration (Cmax) of EMB-15
時間枠：Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Cmax)
|
Through treatment until EOT visit, expected average 6 months
|
|
Trough concentration (Ctrough) of EMB-15
時間枠：Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Ctrough)
|
Through treatment until EOT visit, expected average 6 months
|
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Average concentration over a dosing interval (Css, avg)of EMB-15
時間枠：Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Css, avg).
|
Through treatment until EOT visit, expected average 6 months
|
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Terminal half-life (T1/2) of EMB-15
時間枠：Through treatment until EOT visit, expected average 6 months.
|
Blood samples for serum PK analysis will be obtained (T1/2)
|
Through treatment until EOT visit, expected average 6 months.
|
|
Systemic clearance (CL) of EMB-15
時間枠：Through treatment until EOT visit, expected average 6 months.
|
Blood samples for serum PK analysis will be obtained (CL).
|
Through treatment until EOT visit, expected average 6 months.
|
|
Steady state volume of distribution (Vss) of EMB-15
時間枠：Through treatment until EOT visit, expected average 6 months
|
Blood samples for serum PK analysis will be obtained (Vss).
|
Through treatment until EOT visit, expected average 6 months
|
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Progression free survival (PFS) of EMB-15 as assessed by RECIST 1.1
時間枠：From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
|
Preliminary anti-tumor activity of EMB-15 will be obtained (PFS).
|
From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
|
|
Duration of response of EMB-15 as assessed by RECIST 1.1
時間枠：From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
|
Preliminary anti-tumor activity of EMB-15 will be obtained (DOR).
|
From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
|
|
Incidence and titer of anti-drug antibodies stimulated by EMB-15
時間枠：Up to End of Treatment Follow Up Period (30 days after the last dose)
|
Antibodies to EMB-15 will be assessed to evaluate potential immunogenicity.
|
Up to End of Treatment Follow Up Period (30 days after the last dose)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月26日
一次修了 (推定)
2029年5月31日
研究の完了 (推定)
2029年10月30日
試験登録日
最初に提出
2026年5月19日
QC基準を満たした最初の提出物
2026年5月19日
最初の投稿 (実際)
2026年5月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月15日
QC基準を満たした最後の更新が送信されました
2026年6月11日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。