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New treatment option for Solid Cancers
Official title An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07371663
What this study is testing
What is TCC1727 tablet 90mg?
TCC1727 tablet 90mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid cancers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase Ib/II clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart /olaparib /topotecanfor patients with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- -Voluntarily participate in this study and sign the informed consent form.
- At the time of signing the informed consent, people must be ≥18 years of age (inclusive).
- people must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following...
- Phase Ib :people with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase...
- Phase II Study:Based on different combination therapy groups, people with the following specific tumor types (different population cohorts): TCC1727...
You likely can't join if
- Known primary central nervous system (CNS) tumors (including meningeal tumors); symptomatic brain metastases, spinal cord compression, carcinomatous...
- Major surgery, radiotherapy, chemotherapy, or other investigational anti-tumor therapy completed \ 5 half-lives or \>10 days before the first dose...
- Use of strong CYP3A4 inhibitors or inducers within 14 days before the first dose (e.g., rifampin, rifapentine, St. John's wort, carbamazepine...
- Any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) from prior anti-tumor therapy (except alopecia, pigmentation, or laboratory abnormalities meeting...
- Inability to swallow tablets, gastrointestinal dysfunction, or any condition that may affect drug absorption (per investigator's judgment).
- Uncontrolled severe diseases, including:
See the full eligibility criteria
Who can join
- -Voluntarily participate in this study and sign the informed consent form.
- At the time of signing the informed consent, people must be ≥18 years of age (inclusive).
- people must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or people must have no available...
- Phase Ib :people with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase II.
- Phase II Study:Based on different combination therapy groups, people with the following specific tumor types (different population cohorts): TCC1727 combined with Benmelstobart Group: The study will enroll people with...
- At least one measurable lesion (per RECIST v1.1; lesions previously treated with local therapy may be considered target lesions if they show clear progression per RECIST v1.1).
- people must provide sufficient tumor tissue samples, including but not limited to fresh specimens (preferred) or formalin-fixed, paraffin-embedded (FFPE) tumor tissue obtained within approximately 24 months prior to...
- ECOG performance status score of 0-1 within 7 days prior to the first dose of study drug.
- Expected survival ≥12 weeks.
- Ability to swallow tablets whole and maintain this method of administration.
- Organ function within the following ranges within 7 days prior to the first dose of study drug (no blood component or growth factor therapy within 14 days prior to the first dose):
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- White blood cell count (WBC) ≥3.0 × 10⁹/L;
- Platelet count ≥100 × 10⁹/L;
- Hemoglobin (Hb) ≥90 g/L;
- Serum albumin ≥30 g/L;
- Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for hepatocellular carcinoma or people with liver metastases);
- ALT and AST ≤3 × ULN (≤5.0 × ULN for hepatocellular carcinoma or people with liver metastases);
- Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if bone metastases are present);
- Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula);
- APTT ≤1.5 × ULN and INR or PT ≤1.5 × ULN (for people not receiving anticoagulation therapy);
- QTc \<450 ms (male) or \<470 ms (female), LVEF ≥50%.
- For non-sterilized or fertile female people, medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study and for 6 months after the last dose...
What rules you out
- Known primary central nervous system (CNS) tumors (including meningeal tumors); symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or uncontrolled CNS metastases. Exceptions: people with...
- Major surgery, radiotherapy, chemotherapy, or other investigational anti-tumor therapy completed \ 5 half-lives or \>10 days before the first dose, whichever is longer; palliative radiotherapy completed \>2 weeks before...
- Use of strong CYP3A4 inhibitors or inducers within 14 days before the first dose (e.g., rifampin, rifapentine, St. John's wort, carbamazepine, phenytoin, barbiturates, ketoconazole, itraconazole, clarithromycin...
- Any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) from prior anti-tumor therapy (except alopecia, pigmentation, or laboratory abnormalities meeting inclusion criteria).
- Inability to swallow tablets, gastrointestinal dysfunction, or any condition that may affect drug absorption (per investigator's judgment).
- Uncontrolled severe diseases, including:
- Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg);
- Clinically significant cardiovascular disease within 6 months before the first dose (e.g., myocardial infarction, severe/unstable angina, stroke, ≥Grade 2 congestive heart failure [NYHA classification]);
- Arrhythmia (≥Grade 2 per CTCAE v5.0, including QTcF ≥450 ms [male] or ≥470 ms [female]);
- Unexplained fever ≥38.5°C within 14 days before the first dose or active infection requiring systemic therapy;
- Active viral hepatitis (HBV DNA ≥500 IU/mL for HBsAg-positive and/or anti-HBc-positive people; HCV RNA-positive for anti-HCV-positive people; antiviral therapy required for eligible HBV/HCV-positive people);
- Active syphilis;
- Active tuberculosis;
- Immunodeficiency (e.g., HIV-positive, congenital/acquired immunodeficiency, organ transplant history);
- Poorly controlled diabetes (fasting blood glucose \>10 mmol/L).
- Uncontrolled pleural effusion, pericardial effusion, ascites, or recurrent ascites requiring drainage within 28 days before the first dose.
- Significant bleeding symptoms or tendency within 3 months before the first dose.
- Chronic systemic corticosteroid therapy (\>10 mg prednisone equivalent daily) or immunosuppressive therapy within 14 days before the first dose.
- Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., immunomodulators, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid...
- History of severe allergic reactions to study drugs or their excipients.
- Other malignancies within 3 years before screening (except cured basal cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma).
- Prior ≥Grade 3 immune-mediated adverse events (imAEs) or permanent discontinuation due to imAEs during anti-PD-(L)1 therapy.
- Prior treatment with TCC1727, other ATR inhibitors, or cell cycle checkpoint inhibitors (e.g., ATM inhibitors, WEE1 inhibitors, CHK1/CHK2 inhibitors).
- Other severe physical/mental illnesses or factors that may increase study risk or interfere with results, or any condition deemed unsuitable by the investigator. Additional exclusions:
- Phase II Cohort 1 (NSCLC):Exclude people with known EGFR, ALK, ROS1, BRAF, MET, RET, or RAS mutations; exclude mixed NSCLC/SCLC histology.
- Phase II Cohort 2 (Endometrial Cancer):Exclude uterine carcinosarcoma, endometrial leiomyosarcoma, or endometrial stromal sarcoma.
- Phase II Cohort 3 (Other Solid Tumors):Exclude KRAS/NRAS/BRAF mutations or MSI-H status.
- Phase II Cohort 4 (Ovarian Cancer) \& Ib Phase TCC1727 + Olaparib Tablets: Exclude prior myelodysplastic syndrome or acute myeloid leukemia.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Zhengzhou, Henan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Zhengzhou, Henan, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.