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A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors

2026年11月2日 更新者：Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.

A Phase I, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CG-7321 as Monotherapy or in Combination Therapy in Subjects With Advanced Solid Tumors

This is a Phase I, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CG-7321 capsules as monotherapy or in combination with fulvestrant in subjects with advanced solid tumors.

The study consists of:

  • Part Ia (Monotherapy): Dose escalation (accelerated titration followed by 3+3 design) from 2mg to 50mg twice daily (BID), plus dose expansion cohorts in advanced solid tumors including HR+/HER2- breast cancer, ovarian cancer, gastric cancer, and other tumor types.
  • Part Ib (Combination Therapy): Dose escalation of CG-7321 combined with fulvestrant in HR+/HER2- advanced breast cancer.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

CG-7321 is a novel oral small molecule inhibitor of cyclin-dependent kinases (CDKs), being developed for the treatment of advanced solid tumors. Preclinical studies have demonstrated potent anti-tumor activity in breast cancer, ovarian cancer, and gastric cancer models.

This Phase I study employs a dose escalation design to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of CG-7321.

Part Ia evaluates CG-7321 monotherapy with dose levels of 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, and 50mg BID in a 28-day cycle. Single dosing (Cycle 0) followed by multiple dosing (Cycle 1 onwards) will be evaluated.

Part Ib evaluates CG-7321 in combination with fulvestrant in HR+/HER2- advanced breast cancer patients.

Dose expansion cohorts will further evaluate safety, PK, and preliminary efficacy at or near the RP2D in specific tumor types.

Eligible subjects include patients with histologically/cytologically confirmed advanced or metastatic solid tumors who have failed, are intolerant to, or have no effective standard therapy available, or who refuse standard treatment.

The Part Ia (monotherapy dose escalation) will be conducted first.

研究の種類

介入

入学 (推定)

30

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

研究場所

  • 中国
    • Fujian
      • Fuzhou、Fujian、中国、350014
        • 募集
        • Fujian Cancer Hospital
        • 主任研究者：
          • Fan Wu, MD
        • コンタクト：
    • Liaoning
      • Dalian、Liaoning、中国、116000
        • 募集
        • Zhongshan Hospital of Dalian University
        • コンタクト：
        • 主任研究者：
          • Xiang Li, MD
        • 主任研究者：
          • Ruoyu Wang, MD
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
        • 募集
        • Fudan University Shanghai Cancer Center
        • 主任研究者：
          • Jian Zhang, MD
        • コンタクト：
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • 募集
        • West China Hospital, Sichuan University
        • コンタクト：
        • 主任研究者：
          • Ting Luo, MD
        • 主任研究者：
          • Ping Feng, MD

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 1. Voluntary signed informed consent and compliance with protocol requirements
  • 2. Age ≥18 years, any gender
  • 3. Life expectancy ≥12 weeks
  • 4. Eastern Cooperative Oncology Group（ECOG） performance status 0-1
  • 5. For Ia monotherapy dose escalation: patients with cytologically and/or histopathologically confirmed advanced or metastatic solid tumors who have failed, are intolerant to, or have no effective standard treatment, or who refuse standard treatment
  • 6. Voluntary provision of tumor tissue specimens (archived within 2 years or fresh tissue)
  • 7. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1（RECIST 1.1）
  • 8. Prior anticancer treatment-related toxicities resolved to ≤1 grade (except alopecia)
  • 9. Adequate organ and bone marrow function
  • 10. Negative serum pregnancy test within 7 days before first dose
  • 11. Agreement to use effective contraception from ICF signing to ≥6 months after last dose
  • 12. No breastfeeding during study and ≥6 months after last dose
  • 13. Understanding of study and voluntary written informed consent

Exclusion Criteria:

  • 1. Anticancer therapy (chemotherapy, targeted therapy, biologics, immunotherapy, radiotherapy) within 4 weeks before first dose, or participation in other interventional clinical studies (observational studies excluded)
  • 2. Strong Cytochrome P450 3A4（CYP3A4）inhibitors within 2 weeks before first dose
  • 3. Strong Cytochrome P450 2C8（CYP2C8） inhibitors within 2 weeks before first dose
  • 4. Other active malignancies within 3 years before first dose (except curable tumors treated radically)
  • 5. Primary Central Nervous System（CNS） tumors or CNS metastases that failed local treatment (stable asymptomatic CNS metastases allowed)
  • 6. Conditions affecting drug absorption or Pharmacokinetics（PK） parameters (e.g., uncontrolled nausea/vomiting, chronic diarrhea, malabsorption syndrome)
  • 7. Uncontrolled or significant cardiovascular disease,
  • 8. Active infection requiring systemic therapy within 2 weeks;
  • 9. Major surgery within 4 weeks before first dose (except minor procedures)
  • 10. Known allergy to study drug or excipients
  • 11. Mental or cognitive impairment affecting study compliance
  • 12. Known alcohol or drug dependence
  • 13. Pregnant or lactating women
  • 14. Investigator deems subject unsuitable for study participation

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：非ランダム化
  • 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：CG-7321 2mg BID

CG-7321 capsule 2mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
薬：CG-7321

Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
実験的：CG-7321 6mg BID

CG-7321 capsule 6mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
薬：CG-7321

Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
実験的：CG-7321 12mg BID

CG-7321 capsule 12mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
薬：CG-7321

Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
実験的：CG-7321 20mg BID

CG-7321 capsule 20mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
薬：CG-7321

Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
実験的：CG-7321 30mg BID

CG-7321 capsule 30mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
薬：CG-7321

Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
実験的：CG-7321 40mg BID

CG-7321 capsule 40mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
薬：CG-7321

Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
実験的：CG-7321 50mg BID

CG-7321 capsule 50mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
薬：CG-7321

Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.

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
Dose-Limiting Toxicities (DLTs)
時間枠：DLT observation period [approximately 28 days]

Number of participants experiencing DLTs during DLT evaluation period.
DLT observation period [approximately 28 days]
Maximum Tolerated Dose (MTD)
時間枠：End of dose escalation phase [approximately 6-12 months]

The highest dose level at which ≤2/6 evaluable subjects experience DLT.
End of dose escalation phase [approximately 6-12 months]
Recommended Phase 2 Dose (RP2D)
時間枠：End of dose escalation phase [approximately 6-12 months]

The dose level recommended for Phase 2 studies.
End of dose escalation phase [approximately 6-12 months]
Adverse Events (AEs) and SAEs
時間枠：From first dose to 30 days after last dose [up to approximately 2 years]

Incidence and severity of AEs and SAEs, graded per NCI-CTCAE Version 5.0.
From first dose to 30 days after last dose [up to approximately 2 years]

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR)
時間枠：Every 8 weeks [up to approximately 2 years]

Percentage achieving CR or PR per RECIST v1.1.
Every 8 weeks [up to approximately 2 years]
Disease Control Rate (DCR)
時間枠：Every 8 weeks [up to approximately 2 years]

Percentage achieving CR, PR, or SD per RECIST v1.1.
Every 8 weeks [up to approximately 2 years]
Duration of Response (DoR)
時間枠：From first documented response until disease progression or death [up to approximately 2 years]

Time from first documented response to disease progression or death.
From first documented response until disease progression or death [up to approximately 2 years]
Progression-Free Survival (PFS)
時間枠：From first dose until disease progression or death [up to approximately 2 years]

Time from first dose to disease progression per RECIST v1.1 or death.
From first dose until disease progression or death [up to approximately 2 years]
Overall Survival (OS)
時間枠：From first dose until death [up to approximately 5 years]

Time from first dose to death from any cause.
From first dose until death [up to approximately 5 years]
Observed plasma maximum concentration (Cmax) of CG-7321 and its metabolite
時間枠：Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Area under the concentration-time curve (AUC) of CG-7321 and its metabolite
時間枠：Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Half-life (T1/2) of CG-7321 and its metabolite
時間枠：Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Time to maximum concentration（Tmax） of CG-7321 and its metabolite
時間枠：Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)

その他の成果指標

結果測定
メジャーの説明
時間枠
Biomarkers
時間枠：Baseline and during treatment as tissue samples become available [up to approximately 2 years]

Exploratory biomarker analysis including but not limited to CCNE expression levels.
Baseline and during treatment as tissue samples become available [up to approximately 2 years]
Tumor-to-blood drug concentration ratio
時間枠：At time of tumor biopsy during treatment [up to approximately 2 years]

Ratio of CG-7321 and CG1-Mp2 concentrations in tumor tissue versus peripheral blood.
At time of tumor biopsy during treatment [up to approximately 2 years]

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。

スポンサー

Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.

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 (実際)

2024年7月2日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年10月27日

QC基準を満たした最初の提出物

2026年11月2日

最初の投稿 (実際)

2026年11月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2025年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CG-7321-001
  • CTR20240687/CTR20254836 (レジストリ識別子：ChinaDrugTrials)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。

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