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RecruitingNCT07321574ABP1011T-03Updated Jan 7, 2026

A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors

A Phase 2 interventional study of ABP1011T in SCLC, Extensive Stage and Advanced Solid Tumors, sponsored by Shanghai AB PharmaTech Ltd.. Recruiting at 8 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Shanghai AB PharmaTech Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a multicenter, open-label, multi-cohort investigation exploring the efficacy and safety of ABP1011T tablets in participants with specific target solid tumors, providing a foundation for subsequent clinical research.

Based on safety and efficacy data from the prior Phase I/IIa clinical trial (Protocol Number: ABP1011T-I/II-01), priority enrollment is given to participants with advanced solid tumors including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma (excluding osteosarcoma). Cohort A (Cohort A1, Cohort A2, Cohort A3) comprises the small cell lung cancer cohort: Participants must have failed at least two prior systemic therapies. Cohort B enrolls participants with other advanced solid tumors (excluding osteosarcoma).

ABP1011T tablets are administered as continuous therapy in clinical studies, with a 21-day treatment cycle. Participants take one tablet orally once daily on an empty stomach (with water, avoiding food for at least 1 hour before and after each dose).

02

Conditions studied

  • SCLC, Extensive Stage
  • Advanced Solid Tumors

Keywords

  • SLCL
  • Advanced Solid Tumors
03

In context

Lead sponsor

This is the only study on the registry with Shanghai AB PharmaTech Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily sign the informed consent form and comply with protocol requirements;
  2. Age 18 \<= age \<= 75 years, male or female;
  3. Expected survival >= 12 weeks;
  4. ECOG performance status \<= 1 point;
  5. Patients with advanced solid tumors who have experienced disease progression on standard therapy, intolerance to standard therapy, or lack of effective standard therapy, with histopathological or cytopathological confirmation (priority enrollment for small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, renal cell carcinoma, or other potentially sensitive tumor types. Cohort A is the small cell lung cancer cohort: includes patients who have failed at least two prior systemic therapies; Cohort B includes patients with other advanced solid tumors); At least one measurable lesion meeting RECIST v1.1 criteria;
  6. Recovery from toxic effects of the last prior treatment (CTCAE \<= Grade 1, except for specific conditions such as "alopecia" or "hyperpigmentation"), and the investigator determines that the corresponding AE poses no safety risk;
  7. Systolic blood pressure \<= 140 mmHg, diastolic blood pressure \<= 90 mmHg, with no changes in antihypertensive medications or dosages within 7 days prior to the first dose.
  8. Organ and bone marrow function levels must meet the following requirements: Bone marrow: Absolute neutrophil count (ANC) >= 1.5 × 10\^9/L, platelet count >= 75 × 10\^9/L, Hemoglobin >=90 g/L, with no transfusion of platelets or red blood cells within 14 days prior to the first dose, and no transfusion or treatment with biological response modifiers (e.g., granulocyte colony-stimulating factor, erythropoietin, interleukin-11) within 14 days prior to the first dose; Liver function: No history of liver cirrhosis (decompensated cirrhosis Child-Pugh B or C). For patients without liver metastases: serum total bilirubin (TBIL) \<= 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 × ULN. Patients with liver metastases must have TBIL \<= 2.5×ULN, ALT and AST \<= 5×ULN. Renal function: Serum creatinine \<= 1.5×ULN, or creatinine clearance > 60 mL/min (Cockcroft-Gault formula); Urine protein qualitative \<= 1+; If urine protein qualitative >= 2+, 24-hour urine protein quantification is required. The investigator will determine eligibility based on test results. Coagulation function: Prothrombin time (PT) \<= 1.5 × ULN; International Normalized Ratio (INR) \<= 1.5 × ULN, and activated partial thromboplastin time (APTT) \<= 1.5 × ULN.
  9. Female subjects of childbearing potential must undergo a serum pregnancy test within 3 days prior to initiating study medication, with negative results, and must agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study period and for 6 months after the last study dose. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study period and for 6 months after the last study dose.

Exclusion criteria

Exclusion Criteria:

1. History of or current presence of other malignant tumors, except for the following:

1) Completely resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ; 2) Completely resected secondary primary cancer with no recurrence within five years; 2. Patients with known hypersensitivity to any component of the study drug or similar agents, or with a history of severe allergic reactions; 3. Patients who have received any of the following treatments or medications prior to the first study treatment: 1) Major surgery or severe trauma within 4 weeks before the first study drug administration (Major surgery is defined as any invasive procedure involving extensive excision or breaching of the mesothelial barrier, such as the pleural cavity, peritoneum, or meninges. However, diagnostic tissue biopsies are permitted). Severe trauma refers to unhealed wounds, ulcers, or fractures; 2) Received Chinese herbal medicine or traditional Chinese medicine for antitumor indications within 2 weeks prior to the first study drug dose.

3) Received antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks prior to the first study drug dose; For oral fluoropyrimidine drugs and endocrine therapy, discontinuation \<= 2 weeks or 5 half-lives; for nitrosoureas and mitomycin, discontinuation \<= 6 weeks. If washout time is inadequate due to scheduling or drug PK characteristics, discussion with the sponsor is required; 4) Wthin 1 week prior to first dose, received potent CYP3A4 or CYP2C9 inhibitors or inducers; 5) Within 1 week prior to first dose, received drugs known to significantly prolong the QT interval (e.g., Class Ia and Class III antiarrhythmics); 6) Concurrent use of antiplatelet agents or anticoagulants during the screening period that cannot be discontinued; 4. Patients with known brain metastases, brainstem metastases, spinal cord metastases, and/or compression, or unstable central nervous system metastases. (However, the following situations may be determined through discussion between the investigator and sponsor: If asymptomatic, or with stable brain metastasis symptoms, and if steroids, anticonvulsants, or mannitol therapy has not been used or has been discontinued for >=4 weeks prior to the first study dose, and the investigator determines the benefits outweigh the risks, the subject may be considered for screening and enrollment); 5. Patients with symptomatic, disseminated visceral disease at an advanced stage who are at risk of life-threatening complications in the short term, or patients with pleural effusion, ascites, or pericardial effusion who underwent paracentesis or thoracentesis within three weeks prior to the first study dose; 6. Patients with imaging evidence of tumor encasement or infiltration of major vessels (e.g., pulmonary artery, pulmonary vein, superior vena cava, inferior vena cava), or significant tumor invasion into adjacent organs (aorta, trachea, gastrointestinal tract) adjacent to esophageal or gastrointestinal lesions, resulting in high risk of hemorrhage or fistula formation; and patients who have undergone tracheal stent placement.

7. Within 6 months prior to screening, presence of cardiovascular disease meeting any of the following criteria: 1) Congestive heart failure with cardiac function >= New York Heart Association (NYHA) Class II; left ventricular ejection fraction (LVEF) \< 50%; 2) Severe arrhythmia requiring medication; 3) QTcF (Fridericia formula) > 450 msec in males or > 470 msec in females, or presence of risk factors for torsades de pointes, such as clinically significant hypokalemia as determined by the investigator, history of familial long QT syndrome, or familial arrhythmia history (e.g., Wolff-Parkinson-White syndrome); and abnormal troponin levels; 4) Myocardial infarction, severe/unstable angina, cardiac revascularization, cerebrovascular accident, or similar events within six months prior to dosing; 5) History of >= Grade 3 thromboembolic events within the past 2 years, or currently receiving thrombolytic or anticoagulant therapy due to high thrombotic risk; 8. Electrolite disturbances during screening; 9. Uncontrolled systemic diseases despite treatment, such as diabetes; 10. Current acute pulmonary disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary disease, or treatable reflex interstitial pneumonia; 11. Patients with a clear tendency toward gastrointestinal bleeding, including the following conditions: presence of locally active ulcerative lesions with fecal occult blood test (>=2+); history of melena or hematemesis within the past 2 months; patients deemed by the investigator to be at risk for major gastrointestinal hemorrhage; 12. History of or current unhealed gastrointestinal perforation or visceral fistula; 13. Evidence of active infection:

  1. Hepatitis B (HBV) (requiring both positive hepatitis B surface antigen (HBsAg) and HBV-DNA levels exceeding the center's specified detection limit);
  2. Hepatitis C (requiring both HCV antibody [HCV-Ab] positivity and HCV-RNA levels exceeding the lower limit of detection for the analytical method);
  3. Active local or systemic infection requiring systemic antimicrobial therapy within 4 weeks prior to first dosing, or unexplained fever >38.5°C during screening/prior to first dosing;
  4. Active pulmonary tuberculosis infection identified through medical history or CT examination, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment; 14. Individuals with positive human immunodeficiency virus (HIV RNA) or Treponema pallidum antibody status; 15. Presence of multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or conditions judged by the investigator to severely impair gastrointestinal absorption; 16. History of confirmed neurological or psychiatric disorders, including epilepsy, dementia, depression, etc.; 17. Patients with alcohol or drug dependence, a history of needle phobia or blood phobia, or inability to tolerate venous blood collection; 18. Habitual consumption of grapefruit juice or excessive amounts of tea, coffee, and/or caffeinated beverages, with inability to discontinue during the trial period; 19. Received any investigational drug within 4 weeks prior to first dosing, or concurrent participation in another clinical study (except: participation in an observational, non-interventional clinical study; being in the follow-up period of an interventional clinical study; or completion of the previous study drug administration more than 5 half-lives ago); 20. Female patients who are pregnant or breastfeeding; 21. Patients deemed unsuitable for inclusion in this study by the investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    ABP1011T Tablets in Patients with Advanced Solid Tumor

    Drug: ABP1011T

Interventions

  • DrugABP1011T

    ABP1011T tablets are administered as continuous therapy in clinical studies, with a 21-day treatment cycle. Participants take one tablet orally once daily on an empty stomach (with water, avoiding food for at least 1 hour before and after each dose).

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

    Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Duration of Relief (DOR)

    DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.

    Time frame: Up to approximately 2 years

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

    Time frame: Up to approximately 2 years

  3. Disease Control Rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.

    Time frame: Up to approximately 2 years

  4. Sustained Response Rate

    Proportion of subjects with DoR ≥ 6 months after first dose (based on RECIST v1.1).

    Time frame: Up to approximately 2 years

  5. Overall Survival (OS)

    OS is the time from the date of first dosing date to death due to any cause.

    Time frame: Up to approximately 2 years

  6. Two-Year Overall Survival Rate

    Two-Year Overall Survival Rate

    Time frame: Up to approximately 2 years

  7. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Up to approximately 2 years

07

Study locations

3 of 8 sites recruiting
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan, China
    Not yet recruiting
  • The First Affiliated Hospital of Nanyang Medical College
    Nanyang, Henan, China
    Not yet recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
    Not yet recruiting
  • Liaocheng Second People's Hospital
    Liaocheng, Shandong, China
    Recruiting
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai Municipality, China
    Not yet recruiting
  • Shanxi Bethune Hospital
    Taiyuan, Shanxi, China
    • Huijing Feng, Head Physician · Contact · 14251244@qq.com · 86 15834121235
    Not yet recruiting
  • Neijiang First People's Hospital
    Neijiang, Sichuan, China
    • Shubin Tang, Head Physician · Contact · 11555043@qq.com · 86 13551529663
    Recruiting
  • Shanghai East Hospital
    Shanghai, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07321574
Lead sponsor
Shanghai AB PharmaTech Ltd.
Collaborators
GCP ClinPlus Co., Ltd.
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Dec 30, 2025
Primary completion
Nov 28, 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 7, 2026

Study contacts

Haiping WANG, PhD
Contact
hpwang@abpharma.com
+86 21 5442 6122 ext. 8006

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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