A Phase 1 interventional study of CG-7321 in Advanced Solid Tumors, Breast Cancer and Ovarian Cancer, sponsored by Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.. Recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Phase 1, Interventional, and Treatment
Among 1,927 studies in Breast Neoplasms with a site in China — 865 open to participants now, 1,063 under way, 210 of them phase 3. Breast Neoplasms · China.
Among the 1,927 studies in Breast Neoplasms with a site in China, this one is the 1,309th largest by planned enrollment of the 1,518 interventional ones, is one of 222 that started in 2024, is one of 171 in phase 1, reaches primary completion later than 515 of the 1,062 other live ones, and was the 1,925th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →865 of the 1,927 studies in Breast Neoplasms with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,927 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 222 started in 2024.
Median enrollment 120 across the 1,518 interventional studies, 240 across the 407 observational. Of the 444 that completed or were terminated, 77 (17%) have results posted.
488 of 1,927 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. as lead sponsor.
Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
256 of the studies in Breast Neoplasms with a site in China that are under way reach primary completion within a year, 43 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT06954961Phase 3InventisBio Co., LtdA Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer | 2026-11-30 |
| NCT06968585Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy | 2026-11-30 |
| NCT05780567Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer | 2026-12 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
Among the 1,927 studies in Breast Neoplasms with a site in China, from their registry updates:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CG-7321 capsule 2mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
Drug: CG-7321
CG-7321 capsule 6mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
Drug: CG-7321
CG-7321 capsule 12mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
Drug: CG-7321
CG-7321 capsule 20mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
Drug: CG-7321
CG-7321 capsule 30mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
Drug: CG-7321
CG-7321 capsule 40mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
Drug: CG-7321
CG-7321 capsule 50mg, orally twice daily, 28-day cycle. Cycle 0: Single dose on Day 1. Cycle 1 onwards: Continuous dosing.
Drug: CG-7321
Novel oral cyclin-dependent kinase (CDK) inhibitor. Dose levels: 2mg, 6mg, 12mg, 20mg, 30mg, 40mg, 50mg BID. 28-day cycle.
Dose-Limiting Toxicities (DLTs)
Number of participants experiencing DLTs during DLT evaluation period.
Time frame: DLT observation period [approximately 28 days]
Maximum Tolerated Dose (MTD)
The highest dose level at which ≤2/6 evaluable subjects experience DLT.
Time frame: End of dose escalation phase [approximately 6-12 months]
Recommended Phase 2 Dose (RP2D)
The dose level recommended for Phase 2 studies.
Time frame: 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.
Time frame: From first dose to 30 days after last dose [up to approximately 2 years]
Objective Response Rate (ORR)
Percentage achieving CR or PR per RECIST v1.1.
Time frame: Every 8 weeks [up to approximately 2 years]
Disease Control Rate (DCR)
Percentage achieving CR, PR, or SD per RECIST v1.1.
Time frame: Every 8 weeks [up to approximately 2 years]
Duration of Response (DoR)
Time from first documented response to disease progression or death.
Time frame: 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.
Time frame: 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.
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)
Biomarkers
Exploratory biomarker analysis including but not limited to CCNE expression levels.
Time frame: Baseline and during treatment as tissue samples become available [up to approximately 2 years]
Tumor-to-blood drug concentration ratio
Ratio of CG-7321 and CG1-Mp2 concentrations in tumor tissue versus peripheral blood.
Time frame: At time of tumor biopsy during treatment [up to approximately 2 years]
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.
Of 388 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's planned 29 months is below that.
Counting every sponsor, half of 759 studies reached it within 44 months; a quarter within 25 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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