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NCT07923214

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

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 3 months later.

See at-risk trials from Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 30 → 66 participants Show 7 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Primary completion pushed from Dec 2026 to Apr 2027
    • Study completion pushed from Aug 2027 to Dec 2027
    • Interventions modified
    • Trial arms changed: 7 → 13
    • Study description expanded, about 11 words
    • Study title expanded, about 2 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Dose-Limiting Toxicities (DLTs)
Timeframe: DLT observation period [approximately 28 days]
Maximum Tolerated Dose (MTD)
Timeframe: End of dose escalation phase [approximately 6-12 months]
Recommended Phase 2 Dose (RP2D)
Timeframe: End of dose escalation phase [approximately 6-12 months]
Adverse Events (AEs) and SAEs
Timeframe: From first dose to 30 days after last dose [up to approximately 2 years]

Secondary (9)

Objective Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Response (DoR)
Progression-Free Survival (PFS)
Overall Survival (OS)
Show 4 moreShow less
Observed plasma maximum concentration (Cmax) of CG-7321 and its metabolite
Area under the concentration-time curve (AUC) of CG-7321 and its metabolite
Half-life (T1/2) of CG-7321 and its metabolite
Time to maximum concentration（Tmax） of CG-7321 and its metabolite

Arms and interventions

CG-7321 2mg BIDExperimental

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

CG-7321 6mg BIDExperimental

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

CG-7321 12mg BIDExperimental

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

CG-7321 20mg BIDExperimental

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

CG-7321 30mg BIDExperimental

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

CG-7321 40mg BIDExperimental

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

CG-7321 50mg BIDExperimental

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

CG-7321 30mg BID + FulvestrantExperimental

CG-7321 30mg orally twice daily + Fulvestrant 500mg IM. HR+/HER2- advanced breast cancer.

CG-7321 40mg BID + FulvestrantExperimental

CG-7321 40mg orally twice daily + Fulvestrant 500mg IM. HR+/HER2- advanced breast cancer.

CG-7321 50mg BID + FulvestrantExperimental

CG-7321 50mg orally twice daily + Fulvestrant 500mg IM. HR+/HER2- advanced breast cancer.

CG-7321 30mg BID + LetrozoleExperimental

CG-7321 30mg orally twice daily + Letrozole 2.5mg orally once daily. HR+/HER2- advanced breast cancer.

CG-7321 40mg BID + LetrozoleExperimental

CG-7321 40mg orally twice daily + Letrozole 2.5mg orally once daily. HR+/HER2- advanced breast cancer.

CG-7321 50mg BID + LetrozoleExperimental

CG-7321 50mg orally twice daily + Letrozole 2.5mg orally once daily. HR+/HER2- advanced breast cancer.

Drugs: CG-7321, Fulvestrant, Letrozole

Sites

4 sites in 1 country