Patients with Advanced Solid TumorsPhase 1/2NCT05970016
A Phase I/II Clinical Study in Patients with Advanced Solid Tumor.
A Phase 1/2 study testing TCC1727 tablet（1） and TCC1727 tablet（2） in people with Patients with Advanced Solid Tumors, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a 2-part, phase I/II, open-label, multicenter study designed to evaluate the safety, PK, PD and preliminary efficacy of TCC1727 tablets administered orally QD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients with Advanced Solid Tumors
- What is being tested?
- TCC1727 tablet（1） and TCC1727 tablet（2）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2023to 30 Dec 2025
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects who have provided voluntary informed consent for participation in the study and to follow the protocol requirements
- Male or female subjects 18-70 years of age
- Subjects with histologically or cytologically confirmed malignant advanced solid tumors who have progressed on (or have not been able to tolerate) standard therapy or for whom no suitable effective standard therapy exists
- For Phase I, all tumor types will be enrolled
- For Phase II, Patients with DDR defects detection at central laboratory will be enrolled
- Subject with at least one measurable lesion according to RECIST criteria (version 1.1) for solid tumors will be allowed to include in phase II (if there is no measurable lesion but there are assessable lesions then the subject will be allowed to be included after the judgment of the investigator in phase I only)
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subjects with life expectancy of ≥12 weeks
- Subjects 12-lead ECG evaluation of QT level using Fridericia formula (QTcF) < 450 mse
- Subjects must have the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
- Platelet count (PLT) ≥ 100 × 109/L;
- Hemoglobin (HB) ≥ 9.0 g/L;
- No blood transfusion or hematopoietic stimulating factor treatment within 14 days;
- Bilirubin total ≤ 1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (In case of liver metastasis, ALT and AST ≤ 5 × ULN);
- 24-hour or calculated creatinine clearance (CrCl) ≥ 60 mL/min (according to Cockcroft-Gault formula)*, or the 24-hour creatinine clearance measured in urine is ≥ 50 mL/min, the patient will still be selected. *For CrCl value, the eligibility should be determined using the Cockcroft-Gault formula:
- Male CrCl (mL/min) = body weight (kg) × (140 - age)/[72 × serum creatinine (mg/dL)]
- Female CrCl (mL/min) = male CrCl × 0.85
- International normalized ratio (INR) ≤ 1.5 × ULN, Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Women of childbearing potential agreed to use effective contraceptives during the study treatment period and within 3 months after the end of the study treatment period.
Who cannot join
- Subjects will be excluded from the study based on the following criteria:
- Imaging examination suggests intracranial metastasis, which requires local treatment (in case of asymptomatic or symptomatic brain metastasis requiring no local treatment based on the investigator's judgement, the subject can still be included), or currently taking steroid hormone prior to inclusion, such as >10 mg prednisone (or equivalent) for intracerebral edema from brain metastases; subjects with meningeal carcinomatosis will be excluded regardless of their clinical stability
- History of previously received major surgery or surgical therapy for any cause within 4 weeks of the first dose; radiotherapy, chemotherapy, other clinical trial drugs or other anti-tumor treatment, within 5 half-lives or 3 weeks (whichever is shorter), prior administering the first dose of study drug on Day 1
- History of previous treatment with ATR inhibitors or other DDR related inhibitors (except poly ADP ribose polymerase enzyme (PARP) inhibitors)
- Subjects with a history of another primary malignancy other than:
- carcinomas in situ, (e.g., breast, cervix, and prostate)
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- Locally excised non-melanoma skin cancer
- No evidence of disease from another primary cancer for two or more years and has not taken any anti-cancer treatment in two years. Exceptions are gonadotropin-releasing hormone (GnRH) therapy for prostate cancer and hormonal maintenance therapy for breast cancer.
- Previously received treatment with strong CYP3A4, CYP2C8 and P-gp inhibitors or strong CYP3A4, CYP2C8 and P-gp inducers within 14 days prior to the first medication
- Patients with AE due to previous anti-tumor treatment that has not recovered to ≤ CTCAE grade 1 (except for alopecia, pigmentation and lymphopenia)
- Patients who are unable to swallow the tablets normally, or have abnormal gastrointestinal function that may affect the drug absorption, such as malabsorption syndrome or major resection of the stomach or bowels based on the judgment of the investigator
- Subjects with any severe and/or uncontrolled disease, including:
- Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg)
- Myocardial infarction, arrhythmia (CTCAE grade 2 and above, also including ≥ Class II congestive heart failure (CHF) (New York Heart Association (NYHA) classification) (refer to Appendix-A)
- Active infection or fever of unknown origin ≥ 38.5℃ within 7 days prior to the first medication
- Active viral hepatitis; positive hepatitis B surface antigen and/or hepatitis B core antibody and measured HBV DNA value ≥ 500 IU/ml; positive HCV antibody and measured HCV titer exceeding the upper limit of normal;
- Positive Treponema pallidum antibody;
- History of immunodeficiency, including positive HIV antibody or other acquired or congenital immunodeficiency diseases, or history of organ transplant;
- Poor control of diabetes (fasting blood glucose (FBG) > 10 mmol/L);
- Liver disease such as decompensated liver disease
- Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion as per the investigator opinion
- Patients with clinically significant hemorrhage symptoms or bleeding tendency within 3 months prior to the first study medication
- Known hypersensitivity or contraindication to any drug or any of the components of investigational product
- Any other clinically significant acute or chronic medical or psychiatric or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Lingying Wu, PHD, 86-01-87788996, wulingying@csco.org.cn
Guangwen Yuan, 86-01-87788996, william327@126.com
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TCC1727 Tablets in Patients with Advanced Solid Tumor.
This is a 2-part, phase I/II, open-label, multicenter study designed to evaluate the safety, PK, PD and preliminary efficacy of TCC1727 tablets administered orally QD.
Read the detailed description
The study will be divided into two stages: the first stage is a phase I dose finding study in patients with advanced solid tumors; the second stage is a phase II cohort expansion study.
- Conditions
- Patients with Advanced Solid Tumors
- Being tested
- TCC1727 tablet（1）, TCC1727 tablet（2）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCC1727 tablet（1）Drug
TCC1727 tablet will be administered orally once a day (QD) every morning for 3 days followed by discontinuation for 4 days, and 21 days/cycle on an empty stomach.
TCC1727 tablet（2）Drug
Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning , and 21 days/cycle on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| 5mg treatment group | Experimental | Administered orally once a day (QD) Receives: Drug: TCC1727 tablet（1） |
| 10mg treatment group | Experimental | Administered orally once a day (QD) Receives: Drug: TCC1727 tablet（1） |
| 20mg treatment group | Experimental | Administered orally once a day (QD) Receives: Drug: TCC1727 tablet（1） |
| 40mg treatment group | Experimental | Administered orally once a day (QD) Receives: Drug: TCC1727 tablet（1） |
| 60mg treatment group | Experimental | Administered orally once a day (QD) Receives: Drug: TCC1727 tablet（1） |
| 80mg treatment group | Experimental | Administered orally once a day (QD) Receives: Drug: TCC1727 tablet（1） |
| 100mg treatment group | Experimental | Administered orally once a day (QD) Receives: Drug: TCC1727 tablet（1） |
| 60mg BID treatment group | Experimental | Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning , and 21 days/cycle on an empty stomach. Receives: Drug: TCC1727 tablet（2） |
| 90mg BID treatment group | Experimental | Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning, and 21 days/cycle on an empty stomach. Receives: Drug: TCC1727 tablet（2） |
| 120mg BID treatment group | Experimental | Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning, and 21 days/cycle on an empty stomach. Receives: Drug: TCC1727 tablet（2） |
| 160mg BID treatment group | Experimental | Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning, and 21 days/cycle on an empty stomach. Receives: Drug: TCC1727 tablet（2） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: To determine dose-limiting toxicity (DLT) at each dose level and identify MTD and RP2D.
Phase I: Dose Escalation To observe the tolerability and safety of TCC1727 tablets and determine the maximum-tolerated dose (MTD) and the recommended phase II dose (RP2D) of TCC1727 tablets when administered orally once a day (QD) in 21-day cycle in patients with advanced solid tumors.
Measured: 21 days
Phase II: To evaluate the preliminary efficacy of TCC1727 tablets as measured by ORR in patients with advanced solid tumors with DNA damage response (DDR) defects
Phase II: Cohort Expansion ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for each tumor type. The overall response rate is defined as proportion of subjects who had the best overall response (BOR) of complete response (CR) or partial response (PR).
Measured: 6 months
Secondary outcomes (9)
Phase I: Dose Escalation To observe the preliminary efficacy of TCC1727 tablets as measured by overall response rate (ORR) in patients with advanced solid tumors.
To evaluate the preliminary efficacy by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression free survival (PFS) and overall survival (OS).
Measured: 6 months
Phase I: To evaluate the pharmacokinetic (PK) of TCC1727 tablets in patients with advanced solid tumors
Phase I: Dose Escalation Pharmacokinetic parameters: Tmax
Measured: 21 days
Phase I:
Phase I: Dose Escalation Pharmacokinetic parameters: Cmax
Measured: 21 days
Phase I:
Phase I: Dose Escalation Pharmacokinetic parameters: t1/2
Measured: 21 days
Phase I:
Phase I: Dose Escalation Pharmacokinetic parameters: AUC0-t,
Measured: 21 days
Phase I:
Phase I: Dose Escalation Pharmacokinetic parameters: Cmax,ss
Measured: 21 days
Phase I:
Phase I: Dose Escalation Pharmacokinetic parameters: AUCtau,ss,
Measured: 21 days
Phase I:
Phase I: Dose Escalation Pharmacokinetic parameters: Cmin,ss
Measured: 21 days
Phase II: To evaluate the safety and tolerability of TCC1727 tablets in patients with advanced solid tumors with DDR defects
Phase II: Cohort Expansion Assessment of all AEs, SAEs and TEAEs;
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start7 Aug 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients with 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970016
- Sponsor's protocol ID
- TCC1727-101
- Status last verified
- Mar 2025
- First submitted
- 14 Jul 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TCC1727 Tablets in Patients with Advanced Solid Tumor.
- ClinicalTrials.gov ID
- NCT05970016
- Acronym / sponsor ID
- TCC1727-101
- Conditions
- Patients with Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (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 2-part, phase I/II, open-label, multicenter study designed to evaluate the safety, PK, PD and preliminary efficacy of TCC1727 tablets administered orally QD.
Detailed description
The study will be divided into two stages: the first stage is a phase I dose finding study in patients with advanced solid tumors; the second stage is a phase II cohort expansion study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 5mg treatment group | Experimental | Drug: TCC1727 tablet（1）Administered orally once a day (QD) |
| 10mg treatment group | Experimental | Drug: TCC1727 tablet（1）Administered orally once a day (QD) |
| 20mg treatment group | Experimental | Drug: TCC1727 tablet（1）Administered orally once a day (QD) |
| 40mg treatment group | Experimental | Drug: TCC1727 tablet（1）Administered orally once a day (QD) |
| 60mg treatment group | Experimental | Drug: TCC1727 tablet（1）Administered orally once a day (QD) |
| 80mg treatment group | Experimental | Drug: TCC1727 tablet（1）Administered orally once a day (QD) |
| 100mg treatment group | Experimental | Drug: TCC1727 tablet（1）Administered orally once a day (QD) |
| 60mg BID treatment group | Experimental | Drug: TCC1727 tablet（2）Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning , and 21 days/cycle on an empty stomach. |
| 90mg BID treatment group | Experimental | Drug: TCC1727 tablet（2）Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning, and 21 days/cycle on an empty stomach. |
| 120mg BID treatment group | Experimental | Drug: TCC1727 tablet（2）Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning, and 21 days/cycle on an empty stomach. |
| 160mg BID treatment group | Experimental | Drug: TCC1727 tablet（2）Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning, and 21 days/cycle on an empty stomach. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female subjects who have provided voluntary informed consent for participation in the study and to follow the protocol requirements
- Male or female subjects 18-70 years of age
- Subjects with histologically or cytologically confirmed malignant advanced solid tumors who have progressed on (or have not been able to tolerate) standard therapy or for whom no suitable effective standard therapy exists
- Subject with at least one measurable lesion according to RECIST criteria (version 1.1) for solid tumors will be allowed to include in phase II (if there is no measurable lesion but there are assessable lesions then the subject will be allowed to be included after the judgment of the investigator in phase I only)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (24 listed)
- Imaging examination suggests intracranial metastasis, which requires local treatment (in case of asymptomatic or symptomatic brain metastasis requiring no local treatment based on the investigator's judgement, the subject can still be included), or currently taking steroid hormone prior to inclusion, such as >10 mg prednisone (or equivalent) for intracerebral edema from brain metastases; subjects with meningeal carcinomatosis will be excluded regardless of their clinical stability
- History of previously received major surgery or surgical therapy for any cause within 4 weeks of the first dose; radiotherapy, chemotherapy, other clinical trial drugs or other anti-tumor treatment, within 5 half-lives or 3 weeks (whichever is shorter), prior administering the first dose of study drug on Day 1
- History of previous treatment with ATR inhibitors or other DDR related inhibitors (except poly ADP ribose polymerase enzyme (PARP) inhibitors)
- Subjects with a history of another primary malignancy other than:
- Previously received treatment with strong CYP3A4, CYP2C8 and P-gp inhibitors or strong CYP3A4, CYP2C8 and P-gp inducers within 14 days prior to the first medication
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 |
|---|---|---|
| TCC1727 tablet（1）TCC1727 tablet will be administered orally once a day (QD) every morning for 3 days followed by discontinuation for 4 days, and 21 days/cycle on an empty stomach. | Drug | 100mg treatment group, 10mg treatment group, 20mg treatment group, 40mg treatment group, 5mg treatment group, 60mg treatment group, 80mg treatment group |
| TCC1727 tablet（2）Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning , and 21 days/cycle on an empty stomach. | Drug | 120mg BID treatment group, 160mg BID treatment group, 60mg BID treatment group, 90mg BID treatment group |
Primary outcome
Phase I: To determine dose-limiting toxicity (DLT) at each dose level and identify MTD and RP2D.
Time frame: 21 days
Phase I: Dose Escalation To observe the tolerability and safety of TCC1727 tablets and determine the maximum-tolerated dose (MTD) and the recommended phase II dose (RP2D) of TCC1727 tablets when administered orally once a day (QD) in 21-day cycle in patients with advanced solid tumors.
Phase II: To evaluate the preliminary efficacy of TCC1727 tablets as measured by ORR in patients with advanced solid tumors with DNA damage response (DDR) defects
Time frame: 6 months
Phase II: Cohort Expansion ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for each tumor type. The overall response rate is defined as proportion of subjects who had the best overall response (BOR) of complete response (CR) or partial response (PR).
9 secondary outcomes
Phase I: Dose Escalation To observe the preliminary efficacy of TCC1727 tablets as measured by overall response rate (ORR) in patients with advanced solid tumors.
Time frame: 6 months
Phase I: To evaluate the pharmacokinetic (PK) of TCC1727 tablets in patients with advanced solid tumors
Time frame: 21 days
Phase I:
Time frame: 21 days
Phase I:
Time frame: 21 days
Phase I:
Time frame: 21 days
Phase I:
Time frame: 21 days
Phase I:
Time frame: 21 days
Phase I:
Time frame: 21 days
Phase II: To evaluate the safety and tolerability of TCC1727 tablets in patients with advanced solid tumors with DDR defects
Time frame: 6 months
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 21 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TCC1727 tablet（1） and TCC1727 tablet（2） in people with Patients with Advanced Solid Tumors, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site 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 21 inclusion and 24 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lingying Wu, PHD (86-01-87788996, wulingying@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: To determine dose-limiting toxicity (DLT) at each dose level and identify MTD and RP2D. (time frame: 21 days). The study lists 2 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 21 Mar 2025.