RightFit
RecruitingPhase 1 / Phase 2

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests TER-2013 alone or with fulvestrant in people with advanced solid tumors that have certain AKT/PI3K/PTEN changes. It looks at safety, how the body handles the drug, and whether it works against cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Cancer has spread or grown nearby, cannot be removed by surgery, and has no available treatment meant to cure it.
  • A study-approved test must find an eligible AKT/PI3K/PTEN change in the tumor.
  • Cancer must be able to be checked under study rules. Expansion groups require tumors that can be measured.
  • You must be fully active or able to do light work, and your organs must work well enough.
  • For TER-2013 alone, a tissue test must confirm a solid tumor. Expansion groups accept ovarian, cervical, or uterine lining cancer, or squamous cell cancer of the head and neck, lung, or esophagus.
  • For the TER-2013-alone dose-testing group, you must have received standard treatments unless they were unsafe, caused side effects you could not tolerate, or you refused them. Expansion groups allow no more than 3 past treatment courses for advanced cancer.
  • The TER-2013 plus fulvestrant dose-testing group requires tissue-confirmed advanced breast cancer that cannot be removed or has spread. It must be hormone receptor-positive and HER2-negative, meaning it uses hormones to grow and does not have high HER2 levels.
  • Combination groups require past treatment with an aromatase inhibitor, a drug that lowers estrogen. Combination expansion groups allow no more than 3 past treatment courses for advanced cancer.

Who can't join

  • Your tumor also has a known cancer-driving change in EGFR, KRAS, NRAS, HRAS, or BRAF.
  • You have a serious problem with how your body controls blood sugar.
  • You have active cancer spread to the brain or cancer in the lining around the brain and spinal cord.
  • You had serious coughing up of blood or other serious bleeding within 4 weeks before the first study dose.
  • You have trouble absorbing nutrients, nausea or vomiting not controlled by medicine, or a digestive illness that could affect how TER-2013 enters or is handled by your body.
  • For the TER-2013-alone dose-testing group: you previously took an AKT-blocking drug.
  • For TER-2013-alone expansion groups: you previously took a drug that blocks the AKT/PI3K/PTEN pathway.
  • For combination expansion groups: you previously took an AKT/PI3K/PTEN pathway blocker, fulvestrant or another SERD (a drug that breaks down estrogen receptors), or an mTOR blocker. Some groups with PIK3CA changes allow past PI3K-blocking treatment. Other study rules also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria * Metastatic or locally advanced, unresectable disease * No available treatment with curative intent * Presence of lesions to be evaluated per RECIST v1.1: a. 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 Key Inclusion Criteria for TER-2013 monotherapy arms: * Histologically confirmed diagnosis of: a. \[For TER-2013 dose escalation\]: 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: 1. \[For TER-2013 dose escalation\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused 2. \[For TER-2013 cohort expansion\]: No more than 3 prior lines of treatment in the advanced setting Key Inclusion Criteria for TER-2013 and fulvestrant combination arms * Histologically confirmed diagnosis of: a. \[For TER-2013 + fulvestrant dose escalation\]: 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) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting * Prior Therapy: a. \[For TER-2013 + fulvestrant dose escalation\]: 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) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting Key Exclusion Criteria: * 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. * History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug * 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 * Prior therapy: 1. \[For TER-2013 monotherapy escalation\]: AKT inhibitor 2. \[For TER-2013 monotherapy expansion\]: AKT/PI3K/PTEN pathway inhibitor 3. \[For TER-2013 + fulvestrant combination expansion\]: 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

Study sites (17)

CA

FL

IL

MA

MN

MO

NC

NE

OH

TN

TX

UT

VA

WI