T-1201 / Taivex Therapeutics Corporation, Molecular Targeting Tech - LARVOL DELTA

Phase I multicenter, open-label, dose escalation study of T-1201, a small molecule drug conjugate, to assess safety, pharmacokinetics, and antitumor activity in advanced solid tumors. (ASCO 2025) - P1 | "This study is registered with ClinicalTrials.gov (NCT04866641). Dose escalation/de-escalation rule for the BOIN design.*The enrollment may stop when one of the following criteria is met: The planned sample size has been reached; at least 9 subjects have been treated and evaluable for DLT at one dose level; or all doses explored appear to be overly toxic, and the MTD cannot be determined."

Clinical • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor

Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Taivex Therapeutics Corporation | N=30 ➔ 40

Enrollment change • Solid Tumor

Safety and Tolerability Study for T-1201 Injection 100 Mg Kit in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Taivex Therapeutics Corporation | Trial completion date: Dec 2025 ➔ Jul 2027 | Trial primary completion date: Jun 2024 ➔ Jun 2026

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A novel phosphatidylserine-targeting small molecule drug conjugate (T-1201) for cancer therapy (KSMO 2024) - No abstract available

Oncology

First-in-human phase 1 study of a phosphatidylserine-targeting small molecule drug conjugate (T-1201) in patients with advanced solid tumors (AACR 2024) - P1 | "Once T-1201 via Zn-DPA targets tumor cells, then enzymatic cleavage releases the cytotoxic payload of SN38, the active metabolite of irinotecan. This study has begun enrolling patients and is continuing as planned in Taiwan. 77% of planned patients have been enrolled as of November 2023."

Clinical • Metastases • P1 data • Oncology • Solid Tumor

Taiwei Biotech successfully developed two new anti-cancer drugs to apply for phase II clinical trials by the end of this year [Google translation] (money.udn.com) - "Zhao Yusheng, general manager of Taiwei Biotechnology, said that the company currently has four First-in-Class/ Best-in-Class Targeted anti-cancer drugs, including T-1101 and T-1201, two new anti-cancer drugs with different mechanisms of action, are expected to be put forward for Phase II clinical trials by the end of this year....T-1501 is undergoing preclinical toxicology experiments. It is expected to apply for IND in Taiwan and the United States early next year and carry out the first phase of clinical trials."

IND • New P1 trial • New P2 trial • Oncology • Solid Tumor

Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Taivex Therapeutics Corporation | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Taivex Therapeutics Corporation | Trial completion date: Jul 2023 ➔ Dec 2023 | Trial primary completion date: Sep 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Taivex Therapeutics Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Taivex Therapeutics Corporation

Clinical • New P1 trial • Oncology • Solid Tumor