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

2 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350014
        • Rekrytering
        • Fujian Cancer Hospital
        • Huvudutredare:
          • Fan Wu, MD
        • Kontakt:
    • Liaoning
      • Dalian, Liaoning, Kina, 116000
        • Rekrytering
        • Zhongshan Hospital of Dalian University
        • Kontakt:
        • Huvudutredare:
          • Xiang Li, MD
        • Huvudutredare:
          • Ruoyu Wang, MD
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Rekrytering
        • Fudan University Shanghai Cancer Center
        • Huvudutredare:
          • Jian Zhang, MD
        • Kontakt:
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Rekrytering
        • West China Hospital, Sichuan University
        • Kontakt:
        • Huvudutredare:
          • Ting Luo, MD
        • Huvudutredare:
          • Ping Feng, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: CG-7321

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

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

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

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

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

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

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dose-Limiting Toxicities (DLTs)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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]

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Response Rate (ORR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Biomarkers
Tidsram: 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
Tidsram: 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]

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 juli 2024

Primärt slutförande (Beräknad)

1 december 2026

Avslutad studie (Beräknad)

1 augusti 2027

Studieregistreringsdatum

Först inskickad

27 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

2 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2025

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CG-7321-001
  • CTR20240687/CTR20254836 (Registeridentifierare: ChinaDrugTrials)

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