Advanced Solid TumorsPhase 1NCT07923214
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
A Phase 1 study testing CG-7321 in people with Advanced Solid Tumors and Breast Cancer, run by Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Breast Cancer, Ovarian Cancer
- What is being tested?
- CG-7321
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesChina
- Study dates
- 2 Jul 2024to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jin Tan, +86-18180770362, tanjin@cynogen.com
Ting Luo, MD
- Recruiting
Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116000
Jin Tan, +86-18180770362, tanjin@cynogen.com
Xiang Li, MD
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Jin Tan, +86-18180770362, tanjin@cynogen.com
Fan Wu, MD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jin Tan, +86-18180770362, tanjin@cynogen.com
Jian Zhang, MD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- CG-7321
- Keywords
- CDK inhibitor, Phase I, Dose escalation, Advanced solid tumors, Pharmacokinetics, Maximum tolerated dose
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-7321Drug
Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| CG-7321 2mg BID | Experimental | CG-7321 capsule 2mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. Receives: Drug: CG-7321 |
| CG-7321 6mg BID | Experimental | CG-7321 capsule 6mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. Receives: Drug: CG-7321 |
| CG-7321 12mg BID | Experimental | CG-7321 capsule 12mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. Receives: Drug: CG-7321 |
| CG-7321 20mg BID | Experimental | CG-7321 capsule 20mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. Receives: Drug: CG-7321 |
| CG-7321 30mg BID | Experimental | CG-7321 capsule 30mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. Receives: Drug: CG-7321 |
| CG-7321 40mg BID | Experimental | CG-7321 capsule 40mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. Receives: Drug: CG-7321 |
| CG-7321 50mg BID | Experimental | CG-7321 capsule 50mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. Receives: Drug: CG-7321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLTs)
Number of participants experiencing DLTs during DLT evaluation period.
Measured: DLT observation period [approximately 28 days]
Maximum Tolerated Dose (MTD)
The highest dose level at which ≤2/6 evaluable subjects experience DLT.
Measured: End of dose escalation phase [approximately 6-12 months]
Recommended Phase 2 Dose (RP2D)
The dose level recommended for Phase 2 studies.
Measured: End of dose escalation phase [approximately 6-12 months]
Adverse Events (AEs) and SAEs
Incidence and severity of AEs and SAEs, graded per NCI-CTCAE Version 5.0.
Measured: From first dose to 30 days after last dose [up to approximately 2 years]
Secondary outcomes (9)
Objective Response Rate (ORR)
Percentage achieving CR or PR per RECIST v1.1.
Measured: Every 8 weeks [up to approximately 2 years]
Disease Control Rate (DCR)
Percentage achieving CR, PR, or SD per RECIST v1.1.
Measured: Every 8 weeks [up to approximately 2 years]
Duration of Response (DoR)
Time from first documented response to disease progression or death.
Measured: From first documented response until disease progression or death [up to approximately 2 years]
Progression-Free Survival (PFS)
Time from first dose to disease progression per RECIST v1.1 or death.
Measured: From first dose until disease progression or death [up to approximately 2 years]
Overall Survival (OS)
Time from first dose to death from any cause.
Measured: From first dose until death [up to approximately 5 years]
Observed plasma maximum concentration (Cmax) of CG-7321 and its metabolite
Measured: 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
Measured: 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
Measured: 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
Measured: Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start2 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Accelerated titration combined with 3+3 dose escalation design. Single group assignment. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923214
- Sponsor's protocol ID
- CG-7321-001
- Other IDs
- CTR20240687/CTR20254836
- Status last verified
- Nov 2025
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07923214
- Acronym / sponsor ID
- CG-7321-001
- Keywords
- CDK inhibitor, Phase I, Dose escalation, Advanced solid tumors, Pharmacokinetics, Maximum tolerated dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Accelerated titration combined with 3+3 dose escalation design. Single group assignment. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID.
| Arm | Type | Receives |
|---|---|---|
| CG-7321 2mg BID | Experimental | Drug: CG-7321CG-7321 capsule 2mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. |
| CG-7321 6mg BID | Experimental | Drug: CG-7321CG-7321 capsule 6mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. |
| CG-7321 12mg BID | Experimental | Drug: CG-7321CG-7321 capsule 12mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. |
| CG-7321 20mg BID | Experimental | Drug: CG-7321CG-7321 capsule 20mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. |
| CG-7321 30mg BID | Experimental | Drug: CG-7321CG-7321 capsule 30mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. |
| CG-7321 40mg BID | Experimental | Drug: CG-7321CG-7321 capsule 40mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. |
| CG-7321 50mg BID | Experimental | Drug: CG-7321CG-7321 capsule 50mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG-7321Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle. | Drug | CG-7321 12mg BID, CG-7321 20mg BID, CG-7321 2mg BID, CG-7321 30mg BID, CG-7321 40mg BID, CG-7321 50mg BID, CG-7321 6mg BID |
Primary outcome
Dose-Limiting Toxicities (DLTs)
Time frame: DLT observation period [approximately 28 days]
Number of participants experiencing DLTs during DLT evaluation period.
Maximum Tolerated Dose (MTD)
Time frame: End of dose escalation phase [approximately 6-12 months]
The highest dose level at which ≤2/6 evaluable subjects experience DLT.
Recommended Phase 2 Dose (RP2D)
Time frame: End of dose escalation phase [approximately 6-12 months]
The dose level recommended for Phase 2 studies.
Adverse Events (AEs) and SAEs
Time frame: 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.
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: Every 8 weeks [up to approximately 2 years]
Disease Control Rate (DCR)
Time frame: Every 8 weeks [up to approximately 2 years]
Duration of Response (DoR)
Time frame: From first documented response until disease progression or death [up to approximately 2 years]
Progression-Free Survival (PFS)
Time frame: From first dose until disease progression or death [up to approximately 2 years]
Overall Survival (OS)
Time frame: From first dose until death [up to approximately 5 years]
Observed plasma maximum concentration (Cmax) of CG-7321 and its metabolite
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG-7321 in people with Advanced Solid Tumors and Breast Cancer, run by Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke Lan (+86-13982078904, lanke@cynogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (DLTs) (time frame: DLT observation period [approximately 28 days]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.