No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
205 (estimated)
Sponsor
Terremoto Biosciences Inc. · Industry
Who this trial is looking for
This trial is looking for patients with advanced solid tumors that have specific changes in certain genes. Participants will receive the drug TER-2013 to see how it works and if it helps their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have a metastatic or locally advanced solid tumor.
I do not have any available treatment that can cure my disease.
I have been tested and have a specific gene alteration.
I have an ECOG performance status of 0 or 1.
I have measurable or evaluable disease.
I have adequate organ function.
I've received standard therapies for my cancer, if appropriate.
You may not be able to join if
I have a known mutation in genes like EGFR, KRAS, NRAS, HRAS, or BRAF.
I have clinically significant issues with glucose metabolism.
I have brain metastases or meningitis.
I have had major bleeding or hemoptysis in the last 4 weeks.
I have a condition that affects my gastrointestinal function significantly.
I have taken an AKT or PI3K/AKT/PTEN pathway inhibitor recently.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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.
Trial Locations
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City
State
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Status
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 Onc…
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
Contacts
Terremoto Biosciences, Inc. Clinical Trials Central Contact
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