Actively Recruiting
A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors
Led by Shanghai AB PharmaTech Ltd. · Updated on 2026-01-07
110
Participants Needed
8
Research Sites
152 weeks
Total Duration
On this page
Sponsors
S
Shanghai AB PharmaTech Ltd.
Lead Sponsor
G
GCP ClinPlus Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Voluntarily sign informed consent and follow study rules
- Expected survival of at least 12 weeks
- ECOG performance status of 0 or 1
- Diagnosis of advanced solid tumors with disease progression, intolerance, or lack of effective standard therapy confirmed by pathology
- Priority enrollment for small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, renal cell carcinoma, or other sensitive tumor types
- For small cell lung cancer cohort, failure of at least two prior systemic therapies required
- At least one measurable tumor lesion per RECIST v1.1
- Recovery from toxic effects of previous treatment to Grade 1 or less (except some conditions like alopecia)
- Stable blood pressure (systolic ≤ 140 mmHg, diastolic ≤ 90 mmHg) without recent medication changes
- Adequate bone marrow, liver, kidney function, and coagulation parameters per detailed laboratory criteria
- Female participants of childbearing potential must have negative pregnancy test and agree to effective contraception during and 6 months after study
- Male participants with partners of childbearing potential must agree to effective contraception during and 6 months after study
You will not qualify if you...
- History or current other malignant tumors except certain fully resected cancers without recurrence
- Known allergy to study drug or similar agents or history of severe allergic reactions
- Major surgery or severe trauma within 4 weeks before first dose
- Use of Chinese herbal medicine for antitumor purposes within 2 weeks before first dose
- Antitumor therapy within 4 weeks before first dose (with exceptions for certain drugs and washout times)
- Use of strong CYP3A4 or CYP2C9 inhibitors/inducers or drugs prolonging QT interval within 1 week before first dose
- Concurrent use of antiplatelet or anticoagulant drugs that cannot be stopped
- Known or unstable brain or central nervous system metastases
- Advanced symptomatic visceral disease or recent fluid drainage procedures
- Tumor invasion causing risk of bleeding or fistula and prior tracheal stent placement
- Cardiovascular diseases meeting specified severe criteria within 6 months prior
- Electrolyte disturbances during screening
- Uncontrolled systemic diseases despite treatment
- Current acute pulmonary diseases including pneumonia or pulmonary fibrosis
- History or risk of gastrointestinal bleeding or unhealed perforation/fistula
- Active infections including hepatitis B or C, active tuberculosis, or recent systemic infections
- Positive HIV or syphilis tests
- Conditions impairing oral drug absorption
- History of neurological or psychiatric disorders
- Drug or alcohol dependence or inability to tolerate blood draws
- Habitual consumption of grapefruit juice or excess caffeine not discontinued during the trial
- Participation in other investigational drug studies within 4 weeks or concurrent clinical trials
- Pregnancy or breastfeeding
- Any other condition judged by investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Not Yet Recruiting
2
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Not Yet Recruiting
3
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
4
Liaocheng Second People's Hospital
Liaocheng, Shandong, China
Actively Recruiting
5
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
6
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
7
Neijiang First People's Hospital
Neijiang, Sichuan, China
Actively Recruiting
8
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
H
Haiping WANG, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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