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Solid CancersPhase 1/2NCT07371663

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

A Phase 1/2 study testing TCC1727 tablet 90mg, TCC1727 tablet 120mg and TCC1727 tablet 160mg in people with Solid Cancers and NSCLC (Advanced Non-small Cell Lung Cancer), run by Beijing Tide Pharmaceutical Co., Ltd at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TCC1727 tablet 90mg, TCC1727 tablet 120mg and TCC1727 tablet 160mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
3 sitesChina
Study dates
3 Dec 2025to 30 Jun 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Voluntarily participate in this study and sign the informed consent form.
  • At the time of signing the informed consent, subjects must be ≥18 years of age (inclusive).
  • Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or subjects must have no available standard therapy, be intolerant to or refuse standard therapy, or meet the specific requirements for the corresponding phase and group as follows:
  • Phase Ib :Subjects 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, subjects with the following specific tumor types (different population cohorts):
  • TCC1727 combined with Benmelstobart Group:
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  • The study will enroll subjects with advanced solid tumors lacking standard therapies, including but not limited to non-small cell lung cancer (NSCLC), endometrial cancer, and other advanced solid tumors (e.g., colorectal cancer, urothelial carcinoma, gastric cancer, and gastroesophageal junction cancer):
  • Cohort 1 (NSCLC):Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who are eligible for second- or third-line therapy. Patients must have received prior therapy with an anti-PD-(L)1-containing regimen (either as monotherapy or in combination) and a platinum-based doublet regimen for locally advanced or metastatic NSCLC.
  • Subgroup 1: ATM mutation. Subgroup 2: ATM wild-type, with or without other DDR functional defects.
  • Cohort 2 (Endometrial Cancer):Patients with histopathologically confirmed recurrent or metastatic advanced endometrial cancer who have received at least one prior platinum-based chemotherapy and immune checkpoint inhibitor (PD-1 or PD-L1) therapy (sequential or concurrent therapy allowed; sequential therapy refers to platinum-based chemotherapy followed by immune checkpoint inhibitor maintenance therapy).
  • Subgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.
  • Cohort 3 (Other Advanced Solid Tumors):Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard therapy, are intolerant to standard therapy, have no standard therapy available, or for whom standard therapy is currently unsuitable.
  • Subgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.
  • TCC1727 combined with Olaparib Tablets Group:
  • The study will enroll subjects with histopathologically confirmed recurrent ovarian cancer:
  • Cohort 4 (Ovarian Cancer):Subjects with histopathologically confirmed recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer:
  • Subgroup 1: Subjects who have experienced disease progression after prior Olaparib Tablets therapy (maintenance or subsequent therapy). Subjects must not have received further treatment after progression on Olaparib Tablets.
  • Subgroup 2: Subjects who have not received Olaparib Tablets and have primary platinum-resistant/refractory disease (recurrence within 6 months of last platinum-based therapy). Subjects must have received ≤3 prior lines of therapy since developing platinum resistance.
  • TCC1727 combined with Topotecan Hydrochloride for Injection Group:
  • The study will enroll subjects with histopathologically or cytologically confirmed small cell lung cancer (SCLC):
  • Cohort 5 (SCLC):Subjects who have progressed after platinum-based chemotherapy combined with PD-(L)1 therapy, or subjects with extensive-stage SCLC who have relapsed or progressed within ≤6 months after first-line therapy.
  • 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).
  • Subjects 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 randomization, unstained FFPE slides, or core needle biopsy tissue for biomarker testing.
  • 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 subjects with liver metastases);
  • ALT and AST ≤3 × ULN (≤5.0 × ULN for hepatocellular carcinoma or subjects 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 subjects not receiving anticoagulation therapy);
  • QTc <450 ms (male) or <470 ms (female), LVEF ≥50%.
  • For non-sterilized or fertile female subjects, 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. Non-sterilized female subjects must have a negative serum HCG test within 72 hours before the first dose and must not be breastfeeding. Male subjects with fertile partners must use effective contraception during the study and for 3 months after the last dose.

Who cannot join

  • Known primary central nervous system (CNS) tumors (including meningeal tumors); symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or uncontrolled CNS metastases. Exceptions: Subjects with completely resected and/or irradiated CNS metastases that are stable or improved for ≥4 weeks before screening (no evidence of brain edema and no need for corticosteroids or anticonvulsants). Asymptomatic brain metastases <1 cm in diameter without surrounding edema are also allowed.
  • Major surgery, radiotherapy, chemotherapy, or other investigational anti-tumor therapy completed <4 weeks before the first dose (exceptions: small-molecule anti-tumor therapy completed >5 half-lives or >10 days before the first dose, whichever is longer; palliative radiotherapy completed >2 weeks 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, phenytoin, barbiturates, ketoconazole, itraconazole, clarithromycin, voriconazole, atazanavir, ritonavir, saquinavir, grapefruit juice).
  • 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:
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  • 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 subjects; HCV RNA-positive for anti-HCV-positive subjects; antiviral therapy required for eligible HBV/HCV-positive subjects);
  • 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 replacement for adrenal/pituitary insufficiency) is allowed. (Applies only to Ib Phase and Phase II TCC1727 + Benmelstobart groups.)
  • 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 subjects 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhengbo Song contact

+86 13857153345

songzb@zjcc.org.cn

China3 sites, 3 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jian Fang, +86 13701224460, fangjian5555@yeah.net

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Zhengbo Song, +86 13857153345, songzb@zjcc.org.cn

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Yanqiu Zhao, +86 13938252350, 13938252350@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: An Open-Label, Multicenter Phase Ib/II Clinical Trial of TCC1727 in Combination With Benmelstobart/Olaparib/Topotecan for Advanced Solid Tumors

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.

The Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart /olaparib/topotecanin selected advanced solid tumor indications.

The study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.

Being tested
TCC1727 tablet 90mg, TCC1727 tablet 120mg, TCC1727 tablet 160mg, benmelstobart Injection
Keywords
Ataxia Telangiectasia and Rad3-related protein inhibitor, Advanced solid tumor
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Endometrial Neoplasms, Melanoma, Ataxia Telangiectasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCC1727 tablet 90mgDrug

    TCC1727 tablets 90 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression

  • TCC1727 tablet 120mgDrug

    TCC1727 tablets 120 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression

  • TCC1727 tablet 160mgDrug

    TCC1727 tablets 160 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression

  • benmelstobart InjectionCombination product

    Administer 1200 mg per dose via intravenous infusion on Day 1 of every 3-week cycle until disease progression.

Study groups in NCT07371663
Study groupRoleWhat they receive
TCC1727 + benmelstobart (Dose Level 1)ExperimentalTCC1727 tablets 90 mg orally twice daily (bid) in 21-day cycles combined with benmelstobart injection 1200 mg by intravenous infusion in 21-day cycles until disease progression
Receives: Drug: TCC1727 tablet 90mg; Combination Product: benmelstobart Injection
TCC1727 + benmelstobart (Dose Level 2)ExperimentalTCC1727 tablets 120 mg orally twice daily (bid) in 21-day cycles combined with benmelstobart injection 1200 mg by intravenous infusion in 21-day cycles until disease progression
Receives: Drug: TCC1727 tablet 120mg; Combination Product: benmelstobart Injection
TCC1727 + benmelstobart (Dose Level 3)ExperimentalTCC1727 tablets 160 mg orally twice daily (bid) in 21-day cycles combined with benmelstobart injection 1200 mg by intravenous infusion in 21-day cycles until disease progression
Receives: Drug: TCC1727 tablet 160mg; Combination Product: benmelstobart Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib：To determine dose-limiting toxicity (DLT) at each dose level

    Dose Escalation To observe the tolerability and safety of TCC1727 combination therapy.

    Measured: 21 Days

  2. MTD

    The maximum tolerated dose (MTD) of TCC1727 in combination with benmelstobart/olaparib/topotecan will be determined based on safety, tolerability, kinetics, preliminary efficacy, and other available data

    Measured: 21 days

  3. RP2D

    The recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart/olaparib/topotecan will be determined based on safety, tolerability, kinetics, preliminary efficacy, and other available data

    Measured: 21 days

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Adverse events (AEs) were assessed according to NCI-CTCAE v5.0, including severity grading of abnormal findings in laboratory tests, vital signs, physical examinations, and electrocardiograms (ECGs) from signing of informed consent through the end of the safety follow-up period or prior to the start of a new anticancer therapy

    Measured: 21days

Secondary outcomes (14)

  1. Assess objective response rate (ORR: complete response + partial response), based on RECIST 1.1

    Efficacy evaluation was performed every 6 weeks (± 7 days), extended to 9 weeks (± 7 days) after 8 cycles for efficacy evaluation, and patients were assessed for tumor by the investigator according to RECIST v1.1

    Measured: 6 month

  2. PK parameters of TCC1727

    Blood samples were collected before and after administration of C1, C2 to evaluate the kinetic (PK) parameters of TCC1727: Cmax

    Measured: Day1, Day22

  3. PK parameters of TCC1727

    Blood samples were collected before and after administration of C1, C2 to evaluate the kinetic (PK) parameters of TCC1727: Tmax

    Measured: Day1, Day22

  4. PK parameters of TCC1727

    Blood samples were collected before and after administration of C1, C2 to evaluate the kinetic (PK) parameters of TCC1727: Trough concentration (minimum concentration at steady state)-Ctrough

    Measured: Day1, Day22

  5. AUC0-t

    Blood samples were collected before and after administration of C1, C2 to evaluate the kinetic (PK) parameters of TCC1727:AUC0-t

    Measured: Day1, Day22

  6. AUC0-∞

    Blood samples were collected before and after administration of C1, C2 to evaluate the kinetic (PK) parameters of TCC1727:AUC0-∞

    Measured: Day1, Day22

  7. PK parameters of TCC1727

    Blood samples were collected before and after administration of C1, C2 to evaluate the kinetic (PK) parameters of TCC1727:t1/2

    Measured: Day1, Day22

  8. PK parameters of TCC1727

    Blood samples were collected before and after administration of C1, C2 to evaluate the kinetic (PK) parameters of TCC1727:Clearance

    Measured: Day1, Day22

  9. PK parameters of TCC1727

    Blood samples were collected before and after administration of C1, C2 to evaluate the kinetic (PK) parameters of TCC1727:Volume of distribution at steady state （Vss）

    Measured: Day1, Day22

  10. Assess disease control rate (DCR) based on RECIST 1.1;

    Efficacy evaluation was performed every 6 weeks (± 7 days), extended to 9 weeks (± 7 days) after 8 cycles for efficacy evaluation, and patients were assessed for tumor by the investigator according to RECIST v1.1

    Measured: 6 month

  11. Assess duration of response (DoR) based on RECIST 1.1

    Efficacy evaluation was performed every 6 weeks (± 7 days), extended to 9 weeks (± 7 days) after 8 cycles for efficacy evaluation, and patients were assessed for tumor by the investigator according to RECIST v1.1

    Measured: 6 month

  12. Assess time to response (TTR) based on RECIST 1.1

    Efficacy evaluation was performed every 6 weeks (± 7 days), extended to 9 weeks (± 7 days) after 8 cycles for efficacy evaluation, and patients were assessed for tumor by the investigator according to RECIST v1.1

    Measured: 6 month

  13. Assess progression-free survival (PFS) based on RECIST 1.1

    Efficacy evaluation was performed every 6 weeks (± 7 days), extended to 9 weeks (± 7 days) after 8 cycles for efficacy evaluation, and patients were assessed for tumor by the investigator according to RECIST v1.1

    Measured: 6 month

  14. Assess overall survival (OS) of subjects

    Survival follow-up assessments will be conducted at 12-week intervals (±7 days) to document Overall survival(OS) and subsequent anticancer therapies, with follow-up terminating at the earliest occurrence of study completion, death, loss to follow-up, or patient withdrawal

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start3 Dec 2025
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07371663
Sponsor's protocol ID
TCC1727-II-01
Status last verified
Oct 2025
First submitted
15 Dec 2025
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TCC1727 tablet 90mg, TCC1727 tablet 120mg and TCC1727 tablet 160mg in people with Solid Cancers and NSCLC (Advanced Non-small Cell Lung Cancer), run by Beijing Tide Pharmaceutical Co., Ltd at 3 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 39 inclusion and 29 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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 Zhengbo Song (+86 13857153345, songzb@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib：To determine dose-limiting toxicity (DLT) at each dose level (time frame: 21 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?

On the ClinicalTrials.gov record for NCT07371663.

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 28 Jan 2026.

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