Clinical Trial of TB511 in Advanced Solid Tumors (NCT06400160) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Clinical Trial of TB511 in Advanced Solid Tumors
12 participantsStarted 2026-03
Plain-language summary
1. Study population
\[TB511 Monotherapy Cohort for Phase 1 and Phase 2a Clinical Trial\] Patients with advanced solid tumors who are either refractory or intolerant to standard of care (SoC).
\[Immune checkpoint inhibitors (ICIs) Combination Therapy Cohort for Phase 2a Clinical Trial\] Patients with advanced solid tumors who are refractory to immune checkpoint inhibitors (ICIs) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 inhibitors or who have no available standard of care.
2. Objectives of the Clinical Trial
2.1 Primary Objectives \[Phase 1 Clinical Trial\]
* To evaluate the safety and tolerability of TB511 monotherapy in patients with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D).
\[Phase 2a Clinical Trial\]
* To evaluate the Objective Response Rate (ORR) of TB511 monotherapy and TB511 in combination with Pembrolizumab in patients with advanced solid tumors (based on Response Evaluation Criteria In Solid Tumors Version 1.1, RECIST v1.1).
2.2 Secondary Objectives \[Phase 1 Clinical Trial\]
* To evaluate the safety of TB511 monotherapy.
* To assess the Objective Response Rate (ORR) and anti-tumor activity of TB511 monotherapy (based on RECIST v1.1).
* To characterize the pharmacokinetic (PK) profile of TB511 monotherapy.
\[Phase 2a Clinical Trial\]
* To evaluate the Disease Control Rate (DCR), Duration of Response (DoR), and Progression-Free Survival (PFS) of TB511 monotherapy and TB511 in combination with Pembrolizumab.
* To assess the safety and tolerability of TB511 monotherapy and TB511 in combination with Pembrolizumab.
* To characterize the pharmacokinetic (PK) profile of TB511 monotherapy and TB511 in combination with Pembrolizumab.
2.3 Exploratory Objectives
* To compare changes in biomarker levels of TB511 monotherapy.
* To assess immunogenicity of TB511 by measuring anti-drug antibodies (ADA).
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Male and female adults who are 19 years old or older at the time of obtaining informed consent form.
✓. Patients with at least one measurable lesion by RECIST v1.1.
✓. Patients whose Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1.
✓. Female patients of childbearing potential who have not undergone sterilization surgery must agree to use appropriate contraception\* for 6 months after the end of administration of the investigational product and must satisfy one of the following conditions at the time of screening to establish that they are not pregnant.
✓. Male patients who have not undergone vasectomy must agree to use a barrier method of contraception (i.e., condom) and agree that both they and their partners will use an appropriate method of contraception\* through 6 months after the end of administration of the investigational product.
✓. Patients who have been provided with sufficient explanations on this clinical trial, have voluntarily decided to participate in this clinical trial and have agreed in writing to faithfully comply with the requirements of the clinical trial.
Exclusion criteria
What they're measuring
1
Phase I Clinical trial-Maximum tolerated dose (MTD).
Timeframe: 1 year
2
Phase I Clinical trial-Recommended Phase IIa dose (RP2D).
Timeframe: 1 year
3
Phase IIa Clinical trial-anti-tumor effect-to evaluate the Objective response rate (ORR) of TB511 monotherapy and combination therapy with Pembrolizumab in patients with advanced solid tumors (based on RECIST v1.1).
. Patients who have had other malignant tumors within 5 years prior to the screening (provided, however, that patients with basal cell carcinoma that requires only stable long-term follow-up without treatment can be enrolled).
✕. Patients who had been subject to chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to the screening.
✕. Patients who had undergone major surgery requiring general anesthesia within 4 weeks prior to the screening.
✕. Patients with brain metastasis who have symptoms or required treatment (provided, however, that patients with asymptomatic metastasis that does not require treatment \[excluding anticonvulsants used in maintenance therapy\] can be enrolled).
✕. Patients with systemic disease for which administration of anti-cancer drugs is deemed inappropriate by the investigator.
✕. Patients with the following cardiovascular disease at the screening
✕. Patients who are HIV-positive.
✕. Patients whose participation in the clinical trial is deemed inappropriate by the investigator based on their results of Hepatitis B virus and Hepatitis C virus test.(Not applicable to patients with hepatocellular carcinoma.)