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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai AB PharmaTech Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form and comply with protocol requirements;

Age 18 <= age <= 75 years, male or female;

Expected survival >= 12 weeks;

ECOG performance status <= 1 point;

Disqualifiers

Hepatitis B (HBV) (requiring both positive hepatitis B surface antigen (HBsAg) and HBV-DNA levels exceeding the center's specified detection limit);

Hepatitis C (requiring both HCV antibody [HCV-Ab] positivity and HCV-RNA levels exceeding the lower limit of detection for the analytical method);

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;

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • ABP1011T

    Drug

    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).

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: ABP1011T Tablets in Patients with Advanced Solid TumorExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai AB PharmaTech Ltd.

Lead sponsor

GCP ClinPlus Co., Ltd.

Collaborator