Twinpig Biolab, Inc.

Study population [TB511 Monotherapy Cohort for Phase I and Phase IIa Clinical Trial] Participants with an advanced solid tumor who are either refractory or intolerant to standard of care (SoC).
[Immune checkpoint inhibitors (ICIs) Combination Therapy Cohort for Phase IIa Clinical Trial] Participants with advanced solid tumor who have either not responded to or have relapsed after ICIs that are anti-PD-1 or PD-L1 inhibitors and who have no standard of care available.
Objectives of the Clinical Trial [Phase I Clinical Trial] 1) Primary Objective
To evaluate the safety and tolerability of TB511 monotherapy in Participants with advanced solid tumor to determine maximum tolerated dose (MTD) and recommended Phase IIa dose (RP2D).
2) Secondary Objectives
To evaluate the safety of TB511 monotherapy.
To evaluate the objective response rate (ORR) and anti-tumor effect (based on Response Evaluation Criteria in Solid Tumors Version 1.1, RECIST v1.1) of TB511 monotherapy.
To evaluate the pharmacokinetic characteristics of TB511 monotherapy. 3) Exploratory Objectives
To compare the changes in biomarker levels of TB511 monotherapy.
To evaluate immunogenicity by measuring anti-drug antibodies against TB511 [Phase IIa Clinical Trial]
1) Primary Objective
To evaluate the ORR of TB511 monotherapy and combination therapy with Pembrolizumab in Participants with advanced solid tumors (based on RECIST v1.1).
2) Secondary Objectives
To evaluate the disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) of TB511 monotherapy and combination therapy with Pembrolizumab.
To evaluate the safety and tolerability of TB511 monotherapy and combination therapy with Pembrolizumab.
To evaluate the pharmacokinetic characteristics of TB511 monotherapy and combination therapy with Pembrolizumab.
3) Exploratory Objectives
To compare the changes in biomarker levels of TB511 monotherapy.
To evaluate immunogenicity by measuring anti-drug antibodies against TB511