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Taking people in PortugalPhase 1/2

Tests TER-2013 in advanced solid tumors with PI3K pathway changes

Tests TER-2013 in adults with advanced solid tumors having AKT, PI3K or PTEN changes.

Key facts

Who runs it
Terremoto Biosciences Inc.
Where
Braga and Lisbon, PortugalSee the 2 sitesAlso in 4 other countries, 23 sites
Trial code
Registry title
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Status
Recruiting
Phase
Phase 1/2
People taking part
248 people, planned
Started
23 Sept 2025
Expected to end
28 Feb 2029
Type of study
Interventional, 4 groups
Treatments tested
  • TER-2013
  • Fulvestrant injection
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors that have a change in the AKT/PI3K/PTEN pathway. They get TER-2013, alone or with fulvestrant.

Age
18 years or older
Sex
All sexes can join
Disease stage
Cancer that has spread or is locally advanced and cannot be removed by surgery, with no treatment available that aims to remove all of the disease. Breast cancer must be HR+/HER2-. Expansion cohorts: ovarian, cervical, or squamous cell cancer of the head and neck, lung or esophagus; or endometrial adenocarcinoma.
Earlier treatment
Dose escalation: standard therapies for the tumor type and stage, unless not possible, not tolerated, or refused. Expansion: no more than 3 prior lines of treatment in the advanced setting. Breast cancer with fulvestrant: prior AI-containing treatment; in expansion also a CDK4/6 inhibitor, and a PARP inhibitor if germline BRCA-mutated. People cannot have had an AKT inhibitor or other AKT/PI3K/PTEN pathway inhibitor, depending on the arm.
Biomarker or test result
An AKT/PI3K/PTEN pathway change found by a sponsor approved test. A known EGFR, KRAS, NRAS, HRAS or BRAF driver mutation together with it is not allowed.

Main reasons for not taking part

  • Known EGFR, KRAS, NRAS, HRAS or BRAF driver mutation together with a PI3K/AKT/PTEN change
  • Clinically significant problems with glucose metabolism
  • Active brain metastases or carcinomatous meningitis
  • Significant coughing up of blood or bleeding within 4 weeks before the first dose
  • Gut problems that could stop the drug from being absorbed, such as malabsorption or uncontrolled vomiting

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Metastatic or locally advanced, unresectable disease
  • No available treatment with curative intent
  • Presence of lesions to be evaluated per RECIST v1.1:; Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Advanced solid tumor malignancy harboring an eligible AKT/PI3K/PTEN pathway alteration detected by a sponsor approved test
  • Histologically confirmed diagnosis of:; [For TER-2013 dose escalation]: solid tumor malignancy b. [For TER-2013 cohort expansion]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma
  • Prior therapy:; [For TER-2013 dose escalation]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused; [For TER-2013 cohort expansion]: No more than 3 prior lines of treatment in the advanced setting
  • Histologically confirmed diagnosis of:; [For TER-2013 + fulvestrant dose escalation]: HR+/HER2- advanced unresectable or metastatic breast cancer b. [For TER-2013 + fulvestrant cohort expansion]: i. Received treatment with an AI containing regimen (single agent or in combination), CDK4/6 inhibitor, and PARP inhibitor (if germline BRCA-mutated) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting
  • Prior Therapy:; [For TER-2013 + fulvestrant dose escalation]: Received treatment with an AI containing regimen (single agent or in combination) b. [For TER-2013 + fulvestrant cohort expansion]: i. Received treatment with an AI containing regimen (single agent or in combination), CDK4/6 inhibitor, and PARP inhibitor (if germline BRCA-mutated) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting

Who cannot take part

  • History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug
  • Prior therapy:; [For TER-2013 monotherapy escalation]: AKT inhibitor; [For TER-2013 monotherapy expansion]: AKT/PI3K/PTEN pathway inhibitor; [For TER-2013 + fulvestrant combination expansion]: AKT/PI3K/PTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor; Other protocol-defined Inclusion/Exclusion Criteria apply
  • Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013
  • Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration
  • Clinically significant abnormalities of glucose metabolism
  • Active brain metastases or carcinomatous meningitis

Where in Portugal

Also in 4 other countries, 23 sites

  • Centro Clínico Académico de BragaBraga, PortugalContact: Jorge Rodrigues, MDNot yet recruiting
  • START LisboaLisbon, PortugalContact: Recruitment SpecialistTaking people

About the trial

What the trial wants to find out

This is a Phase 1/2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT/PI3K/PTEN pathway alterations.

The 4 groups in the trial

  • Monotherapy Dose EscalationTreatment being tested

    Treatment: TER-2013

  • Combination Therapy Dose EscalationTreatment being tested

    Dose Escalation of TER-2013 with recommended dose of fulvestrant

    Treatment: TER-2013 and Fulvestrant injection

  • Monotherapy Dose ExpansionTreatment being tested

    Treatment: TER-2013

  • Combination Therapy Dose ExpansionTreatment being tested

    Dose Expansion of TER-2013 with recommended dose of fulvestrant

    Treatment: Fulvestrant injection and TER-2013

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Plain-language title
Tests TER-2013 in advanced solid tumors with PI3K pathway changesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 October 2026