In short
TER-2013-01 is an investigational oral medicine being studied for solid tumours with changes in the AKT, PI3K, or PTEN genes. One Phase 1/2 trial (NCT07109726) is currently authorised and plans to enrol 370 participants. The trial is testing TER-2013-01 alone and in combination with other cancer medicines, including fulvestrant for HR+/HER2− breast cancer.
Key points
- TER-2013-01 is an investigational oral substance studied in solid tumours with AKT, PI3K, or PTEN pathway alterations.
- The single authorised trial is Phase 1/2 and plans to enrol 370 participants.
- The trial tests TER-2013-01 alone and in combination with fulvestrant or other ER antagonists/degraders.
- Phase 1 measures safety, tolerability, and dose-limiting toxicities according to NCI CTCAE v5.0.
- Phase 1 expansion and Phase 1b measure objective response rate, duration of response, progression-free survival, and overall survival.
- The trial includes a combination arm for HR+/HER2− breast cancer.
What is TER-2013-01?
TER-2013-01 is an investigational substance being developed as an oral treatment for cancer. It is not yet authorised as a medicine. The substance is being studied in people with solid tumours that carry alterations in the AKT, PI3K, or PTEN signalling pathway. These are genes that help control how cells grow and survive. The full name TER-2013-01 appears in the trial record, and the short label TER-2013 is used in the trial title.
The trial record lists TER-2013 as an oral drug under investigation. The record also names Inluriyo 200 mg film-coated tablets and Fulvestrant Ribosepharm 250 mg solution for injection as other interventions in the same trial. These are used as comparison or combination treatments, not as the studied substance itself. Fulvestrant is an ER antagonist/degrader used in the combination arm for HR+/HER2− breast cancer.
How does TER-2013-01 work?
The trial record does not describe the mechanism of action of TER-2013-01 in detail. The trial is designed for patients whose tumours have alterations in the AKT, PI3K, or PTEN pathway. These genes are part of a signalling network that controls cell growth, division, and survival. When the pathway is altered, cells can grow in an uncontrolled way. The trial aims to test whether TER-2013-01 can affect this pathway in people with such alterations.
Which conditions is TER-2013-01 studied for?
- Solid tumours with AKT/PI3K/PTEN pathway alterations — the main group studied in the trial. These are cancers that form solid masses and carry specific genetic changes in the AKT, PI3K, or PTEN genes.
- HR+/HER2− breast cancer — a type of breast cancer that is hormone-receptor positive and does not overexpress the HER2 protein. The combination part of the trial studies TER-2013-01 together with ER antagonists/degraders such as fulvestrant in this condition.
How is TER-2013-01 given?
TER-2013-01 is given by mouth as an oral drug. The trial record lists it as "Drug: TER-2013 (ORAL)". No specific pharmaceutical form, such as tablet or capsule, is stated in the registry data. The combination arm also includes fulvestrant, which is given as an intramuscular injection.
What do the clinical trials show?
There is one authorised clinical trial for TER-2013-01. It is a Phase 1/2 interventional study with a planned enrolment of 370 participants. The trial is not yet recruiting, as its status is listed as authorised.
The trial has two main parts. The Phase 1 dose escalation and Phase 1b combination dose escalation part aims to characterise the safety and tolerability of TER-2013-01 as monotherapy and in combination with ER antagonists/degraders. It also aims to determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of TER-2013-01 alone and with fulvestrant. The Phase 1 cohort expansion and Phase 1b combination cohort or dose expansion part aims to evaluate the preliminary clinical activity of TER-2013-01 in advanced solid tumours and in combination with ER antagonists/degraders in HR+/HER2− breast cancer.
In the Phase 1 dose escalation and safety lead-in part, the primary outcomes are the incidence of adverse events, the incidence of dose-limiting toxicities, and changes from baseline in safety parameters, all assessed according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. In the Phase 1 cohort expansion and Phase 1b combination part, the primary outcome is objective response rate (ORR). Secondary outcomes include duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
Who can take part in the trial?
The trial enrols patients with solid tumours harbouring AKT, PI3K, or PTEN pathway alterations. The combination part of the trial enrols patients with HR+/HER2− breast cancer. The registry record does not provide detailed eligibility criteria such as age limits, previous treatments, or specific tumour types beyond these pathway alterations.
What side effects are known?
The trial is designed to measure side effects as a primary outcome in its Phase 1 part. The record lists the incidence of adverse events, the incidence of dose-limiting toxicities, and changes from baseline in safety parameters as outcomes. However, the registry data do not describe specific side effects that have already been observed. No supplementary sources with side effect information were provided.